Reported trial results for Asthma

179 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT04609878 · results posted 30 June 2026

  According to the results reported on ClinicalTrials.gov, this trial (known as KALOS) enrolled 2,144 adults with asthma across four treatment groups. The groups tested two different dose combinations of a triple-ingredient inhaler called BGF MDI (at lower and higher doses of one ingredient), a double-ingredient inhaler called BFF MDI, and a commonly used comparator inhaler called Symbicort. The trial ran for 24 weeks and primarily measured two things: changes in lung function (specifically how much air participants could forcefully breathe out in one second, known as FEV1) and the rate of severe asthma flare-ups. A total of 1,968 participants completed the study. The reported data shows that, after 24 weeks, all four groups showed improvements from their starting lung function scores. The average improvement in a lung function measure taken over a three-hour window was 0.281 litres for the lower-dose BGF group, 0.316 litres for the higher-dose BGF group, 0.249 litres for the BFF group, and 0.220 litres for the Symbicort group. For severe asthma flare-ups — which were counted across this trial and a companion trial combined — the reported rates per person per year were 0.533 for lower-dose BGF, 0.541 for higher-dose BGF, 0.604 for BFF, and 0.662 for Symbicort. Secondary measures of lung function before the morning dose and at just five minutes after the first dose also showed small increases across all groups, with figures ranging from roughly 0.07 to 0.16 litres depending on the group and timepoint. The reported data also shows that, at week 24, the number of participants whose asthma control questionnaire scores improved by a meaningful amount (a drop of 0.5 or more on two different versions of the questionnaire) ranged from 207 to 394 participants depending on the group and questionnaire used, though the total number of participants per group varied, so direct comparisons of those raw numbers require care. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03926741 · results posted 20 May 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 48 people in total — 10 healthy participants and 38 with asthma. The study was investigating how the lungs process a substance called GSNO (S-nitrosoglutathione), which occurs naturally in the airways. To do this, researchers measured two things in participants' breath and lung function: the level of nitric oxide in exhaled breath (called FeNO, a by-product of GSNO breakdown), and the amount of air a person can forcefully breathe out in one second (called FEV1, a standard check of how well the lungs are working). All 10 healthy participants and 19 of the 38 asthma participants completed the study; the remaining 19 asthma participants did not complete it, though the reason was not detailed in the reported data. The reported data shows that, before receiving GSNO, the exhaled nitric oxide level averaged 14.3 parts per billion in the healthy group and 34.3 parts per billion in the asthma group. After receiving GSNO, those figures rose to 36.0 and 49 parts per billion respectively, with a later reading of 25 and 42 parts per billion. For lung function, the reported data shows the healthy group averaged 3.55 litres before and 3.57 litres after GSNO, while the asthma group averaged 3.21 litres before and 3.27 litres after. The reported data also shows results from a separate analysis of airway tissue samples, which looked at the activity levels of three enzymes involved in breaking down GSNO. In the healthy bronchoscopy group, the three enzymes measured 938, 96, and 376 relative fluorescence units respectively, compared with 1,062, 115, and 308 in the asthma bronchoscopy group. The researchers noted that this part of the analysis was limited by a low number of usable tissue samples. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04718389 · results posted 18 May 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04718389) enrolled 859 people in the depemokimab group and 858 people in the comparison group, who received either mepolizumab or benralizumab — all existing asthma medicines given by injection under the skin. The trial ran for 52 weeks and was designed to compare how often participants in each group experienced serious asthma flare-ups (defined as episodes needing steroid medicines, a hospital stay, or an emergency department visit). Around 763–772 people in each group completed the full study period. The reported data shows that, on average, people in the depemokimab group had 0.57 serious asthma flare-ups per person per year, while people in the comparison group had 0.49 flare-ups per person per year. For the secondary measures — which looked at quality of life, asthma symptom control, and a breathing test (how much air a person can forcefully breathe out in one second) — the reported changes from the start of the trial were very small in both groups. Quality of life scores (measured using the St. George's Respiratory Questionnaire, where a lower score means better health) changed by about −0.69 in the depemokimab group and −0.86 in the comparison group. Asthma symptom control scores (where lower means better control) changed by +0.03 and +0.06 respectively. The breathing test result changed by −0.014 litres and −0.018 litres in each group. The reported data shows that these numbers were broadly similar across both groups for all measures, though this summary does not include any formal statistical comparison between the groups, as that was not provided in the submitted data. No conclusions about which treatment performed better, or about safety, should be drawn from this plain description alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00861926 · results posted 7 May 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 857 participants in each of two groups — a total of 1,714 people — all of whom had asthma. One group used an inhaler called Foster (Treatment A) on its own, while the other group used Foster together with a reliever inhaler called Ventolin (Treatment B). The trial was primarily measuring how long it took before participants had a severe asthma flare-up, defined as a flare-up serious enough to require a hospital visit, an emergency room visit, or at least three days of steroid tablets. The reported data shows that the time to a first severe flare-up could not be summarised as a single middle-point figure, because not enough participants reached that point during the study. Instead, the researchers tracked how many people in each group had experienced a severe flare-up by the end of each stage of the trial. By the final time point, the reported numbers show 99 participants in the Foster-only group and 152 participants in the Foster-plus-Ventolin group had experienced at least one severe flare-up. For secondary measures, the reported rate of severe flare-ups was approximately 17.6 events per 100 patients per year in the Foster-only group, compared with about 26.8 in the Foster-plus-Ventolin group. Hospital or emergency room visits due to asthma were reported at roughly 9.1 events per 100 patients per year for Foster only, versus about 13.5 for Foster plus Ventolin. Both groups also showed changes in their asthma control questionnaire scores (a self-reported measure of symptom burden, ranging from 0 meaning fully controlled to 6 meaning severely uncontrolled), with both groups reporting lower — that is, improved — scores over time compared to where they started, though the specific figures at each time point varied slightly between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02296411 · results posted 22 April 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT02296411) involved 98 people in total — 50 in one group and 48 in the other. It used a "crossover" design, meaning each participant received both the active inhaler (CHF5259 pMDI) and a placebo inhaler at different times, in a different order. The trial was measuring lung function, specifically how much air a person could forcefully breathe out in one second (known as FEV1). Researchers tracked this over 12 hours after a dose, on both the first day and after 42 days of use. The reported data shows that on Day 42, the average FEV1 reading tracked across 12 hours was 2.470 litres for those on the active inhaler and 2.373 litres for those on the placebo (in the main analysis group). A similar pattern was seen in a second analysis group: 2.480 litres versus 2.365 litres. When looking at the single highest FEV1 reading on Day 42, the reported data shows that participants on the active inhaler had an average increase from their starting point of 0.394 litres, compared with 0.278 litres for those on the placebo. On Day 1, the 12-hour average FEV1 was reported as 2.482 litres for the active inhaler group and 2.356 litres for the placebo group. Over the first 3 hours on Day 1, the reported averages were 2.496 litres and 2.344 litres respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05091385 · results posted 28 January 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 106 adults with severe asthma in Poland who were receiving treatment with a biological medicine called mepolizumab through a national drug programme. All 106 participants completed the study. The trial tracked several things over 52 weeks, including how often participants had serious asthma flare-ups, how many needed daily steroid tablets, and scores from questionnaires about asthma control and quality of life, as well as a breathing test and a blood cell count. The reported data shows that in the year before treatment, participants had on average 3 asthma flare-ups (episodes serious enough to need steroid treatment), and this figure was reported as 0 at both the 24-week and 52-week points during treatment. The number of participants needing ongoing daily steroid tablets was reported as 70 at the start, dropping to 20 at 24 weeks and 15 at 52 weeks. For the asthma control questionnaire (scored 0–6, where higher means worse control), the average score started at 3.48 and was reported as 1.53 at 24 weeks and 1.31 at 52 weeks — the questionnaire's authors consider a change of 0.5 or more to be meaningful. The quality-of-life questionnaire (scored 1–7, where higher means better quality of life) started at an average of 2.47 and was reported as 5.8 at 24 weeks and 5.3 at 52 weeks. The breathing test result (measuring how much air participants could forcefully breathe out in one second, expressed as a percentage of what would be expected for a healthy person of the same age and size) started at 62% and was reported at 76% at both the 24- and 52-week marks. Finally, a type of immune cell in the blood called eosinophils — which are often elevated in this type of asthma — started at an average of 605 cells per microlitre of blood and was reported as 60 cells per microlitre at both later time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05243680 · results posted 15 January 2026

  According to the results reported on ClinicalTrials.gov, this extension trial (NCT05243680) enrolled 641 participants in total — 214 who had previously received a placebo in earlier studies, and 427 who had previously received the study drug, GSK3511294 (given as an injection under the skin). Both groups then received GSK3511294 100 mg injections during this extension phase. The trial was measuring tolerability-related events, immune responses to the drug, and several measures of asthma symptoms and quality of life over time. The reported data shows that, among participants who previously received placebo and then switched to GSK3511294, 147 out of 210 experienced at least one adverse event (an unwanted medical occurrence during the study), and 21 experienced a serious adverse event (one that was life-threatening, required hospitalisation, or caused significant disability). In the group that continued on GSK3511294, 301 out of 419 experienced at least one adverse event, and 38 experienced a serious adverse event. Regarding immune responses to the drug itself, 15 participants in the placebo-switcher group and 40 in the continuing group developed detectable antibodies against GSK3511294; neutralising antibodies (a specific type that can interfere with a drug) were found in 0 and 5 participants respectively. For asthma flare-ups requiring steroids or hospitalisation, both groups had a reported rate of approximately 0.55–0.58 episodes per person per year. On the asthma symptom control questionnaire (scored 0–6, where lower is better), both groups showed small reductions from their starting scores across the study period. On the quality-of-life questionnaire (scored 0–100, where lower is better), both groups also showed modest reductions from their starting scores at the measured timepoints. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05660850 · results posted 16 December 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05660850) involved 49 people in the main part of the study (Part A), split into two groups in a "crossover" design — meaning each person received both the study drug (GDC-6599) and a dummy treatment (placebo) at different points in time, so they acted as their own comparison. A very small pilot group (Part B) included just 2 people. The trial was mainly measuring how often participants coughed over a 24-hour period, recorded by a wearable device called the VitaloJAK®. It also looked at how severe participants felt their cough was, using two self-rating scales, and tracked any unwanted medical events (called adverse events) that occurred during the study. The reported data shows that when participants were taking GDC-6599, they coughed an average of about 14.9 times per hour, compared to about 17.3 times per hour when taking the placebo — both measured at the start of each treatment period. By the end of each treatment period, those figures were approximately 12.6 coughs per hour on GDC-6599 and 13.2 coughs per hour on placebo. For the self-rated cough severity scales, the reported data shows that both groups improved from their starting scores: on the visual scale (0–100), scores fell by about 11.2 points on GDC-6599 and 9.6 points on placebo; on the 0–10 numeric scale, scores fell by about 1.2 points on GDC-6599 and 1.0 points on placebo. Regarding blood levels of GDC-6599, the reported data shows measurable drug concentrations in participants who received GDC-6599, while those on placebo had levels at or below the detection limit; some time-point figures were listed as "not available" and were not reported. The reported data shows that 18 out of the participants who received GDC-6599 experienced at least one adverse event, compared with 13 out of those who received placebo; the data as submitted does not provide a breakdown of what those events were. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03560466 · results posted 21 November 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03560466) involved 378 participants in total. The main study enrolled 365 people split into two groups: 125 who received a placebo first and then switched to the study drug dupilumab, and 240 who received dupilumab throughout. A smaller sub-study based in Japan enrolled 13 additional participants, all of whom received dupilumab. The trial was measuring, among other things, how many people experienced unwanted medical events during treatment (called treatment-emergent adverse events), how well participants could breathe out air from their lungs (measured using a breathing test called FEV1 — essentially a score of lung function), and how often participants had severe asthma flare-ups requiring steroid treatment or a hospital visit. The reported data shows that in the main study, 85 out of 125 participants in the placebo-then-dupilumab group, and 147 out of 240 participants in the dupilumab-throughout group, experienced at least one treatment-emergent adverse event during the study period. In the Japan sub-study, all 13 participants experienced at least one such event. Regarding lung function in the Japan sub-study, the reported data shows an average improvement of 7.08 percentage points in the FEV1 breathing score from the starting point to week 12. For severe asthma flare-ups, the reported rate was approximately 0.11 events per person per year in the placebo-then-dupilumab group, 0.12 in the dupilumab-throughout group, and 0.46 in the Japan sub-study group. Changes in lung function (FEV1) over time were also reported across multiple time points, with the dupilumab-throughout group generally showing slightly higher improvements in breathing scores compared to the placebo-then-dupilumab group, though the full breakdown of individual time points was not clearly separated in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03545906 · results posted 8 September 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03545906) involved 326 participants in total, split into two groups of 163 people each. One group received the TEAM-UP intervention, while the other received what was called "enhanced care" for comparison. The trial tracked a condition's symptoms over time, with the main thing being measured being the average number of days out of the previous 14 days that participants were free of symptoms. The reported data shows that across four separate measurement points during the study, the TEAM-UP intervention group reported the following average symptom-free days (out of a possible 14): 9.21 days, 10.4 days, 10.1 days, and 9.6 days. The enhanced care comparison group reported averages of 8.21 days, 9.1 days, 8.9 days, and 8.9 days at those same time points. By the end of the study, 139 participants in the TEAM-UP group and 137 in the enhanced care group had completed the trial, with 24 and 26 people respectively not completing it. No secondary outcome data was included in the submitted results. It is worth noting that the reported results do not include information about how confident researchers were in these numbers, or whether the differences between the two groups were considered statistically meaningful (that is, unlikely to be due to chance). That additional detail was not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05292586 · results posted 4 September 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 576 participants in total — 287 in the CHF 1535 pMDI group and 289 in the CHF 718 pMDI group. The trial was comparing two inhaler treatments over 12 weeks in people with a breathing condition. The main thing being measured was lung function, specifically a test called FEV1 (how much air a person can forcefully breathe out in one second), tracked over a 12-hour period after taking the inhaler. A total of 276 participants completed the study in the CHF 1535 group and 267 in the CHF 718 group. The reported data shows that for the primary measure — the average change in lung function over 12 hours at the 12-week mark, compared to where participants started — the CHF 1535 group showed an average increase of 0.279 litres, while the CHF 718 group showed an average increase of 0.174 litres. These are changes from each participant's own starting point, not comparisons between groups. For the secondary measures, the reported data shows similar patterns: the best single lung function reading in the first three hours after dosing at week 12 increased by an average of 0.419 litres in the CHF 1535 group and 0.295 litres in the CHF 718 group. Lung function measured just before the next dose at week 12 (called "trough," meaning the lowest point before the next dose) increased by an average of 0.212 litres and 0.143 litres respectively. Results at earlier time points (weeks 4 and 8) and on the first day of dosing followed a broadly similar pattern across both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04643158 · results posted 28 August 2025

  According to the results reported on ClinicalTrials.gov, this trial tested an inhaled medicine called AZD1402 in adults with asthma. It was run in two parts. Part 1 included 50 people split across three different dose levels of AZD1402 or a placebo (a dummy treatment with no active ingredient), and focused on tracking unwanted events (called adverse events) that participants experienced. Part 2 included 22 people across two dose levels of AZD1402 or a placebo, and focused on measuring a breathing test called FEV1 — which measures how much air a person can forcefully breathe out in one second — before using a reliever inhaler. The reported data shows that in Part 1, the number of participants who experienced adverse events was 4 out of 11 in the lowest dose group, 6 out of 10 in the middle dose group, 10 out of 13 in the highest dose group, and 8 out of 16 in the placebo group. No serious adverse events or deaths were recorded in the data provided. For Part 2, the reported change in the FEV1 breathing test from the start of the trial was a small decrease of 0.02 litres in the lowest AZD1402 dose group, an increase of 0.15 litres in the higher dose group, and a small decrease of 0.04 litres in the placebo group. The reported data also shows that the drug was detectable in participants' blood, with peak blood levels and the time the drug remained in the body varying across dose groups; some figures for certain groups were not reported in the data. Antibody responses to the drug (where the body recognises the medicine as a foreign substance) were also measured and detected in some participants across both parts of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05457855 · results posted 11 August 2025

  According to the results reported on ClinicalTrials.gov, this trial looked at whether there was a difference in the rate of dementia diagnoses — including Alzheimer's disease and other forms of dementia — among people taking one of two existing medications: montelukast (commonly used for asthma and allergies) or fluticasone (a steroid inhaler). Around 12,575 people were in the montelukast group and 38,958 were in the fluticasone group at the start. By the end of the study period, 12,572 people from each group were counted as having completed the study. The trial used existing health records rather than assigning new treatments to participants. The reported data shows that the main thing being measured was how often dementia was diagnosed over time, expressed as a rate per 1,000 person-years (meaning: out of every 1,000 people followed for one year, how many received a dementia diagnosis). The results included several sets of figures across what appear to be different subgroups or time points. For the montelukast group, the reported rates were 9.1, 14.5, 11.4, and 3.5 per 1,000 person-years. For the fluticasone group, the corresponding reported rates were 5.6, 14.2, 8.6, and 1.8 per 1,000 person-years. No further breakdown or labels for these subgroups were provided in the submitted data, so the data was not reported in enough detail to explain what each set of numbers specifically refers to. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03927157 · results posted 1 July 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03927157) enrolled 400 adults with asthma — 201 received tezepelumab (210 mg every four weeks by injection) and 199 received a placebo (an inactive treatment). The trial ran for 52 weeks and was primarily measuring how often participants had asthma flare-ups (called "exacerbations") over the course of a year. It also measured several secondary things, including a lung function test, asthma symptom scores, asthma control scores, and quality of life scores. By the end of the study, 186 people in the tezepelumab group and 168 in the placebo group had completed the trial. The reported data shows that the tezepelumab group had an average of 0.42 asthma flare-ups per year, compared to 1.63 per year in the placebo group. For the lung function test — which measured how much air a person can forcefully breathe out in one second (called FEV1) — the tezepelumab group showed an average increase of 0.35 litres from their starting point, while the placebo group showed an increase of 0.11 litres. Regarding time to first flare-up, 45 out of 201 participants in the tezepelumab group experienced at least one flare-up, compared to 89 out of 199 in the placebo group. The reported data also shows changes in questionnaire scores over 52 weeks. On the asthma quality of life questionnaire (scored 1–7, where higher means better quality of life), the tezepelumab group improved by 1.29 points on average, compared to 0.94 points in the placebo group. On the asthma control questionnaire (scored 0–6, where lower means better control), the tezepelumab group's score decreased by 1.34 points and the placebo group's decreased by 1.03 points. On the daily asthma symptom diary (scored 0–4, where lower means fewer symptoms), the tezepelumab group's score decreased by 0.61 points compared to 0.44 points in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04007198 · results posted 18 April 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 18 people in total, split across three groups: 7 received a lower dose of the study drug EQ001 (0.8 mg/kg), 7 received a higher dose (1.6 mg/kg), and 4 received a placebo (an inactive substance used for comparison). Of those who started, 16 completed the study — one person from each of the two active-dose groups did not finish, while all four placebo participants completed it. The trial was primarily measuring how many participants experienced unwanted health events (called "adverse events") that appeared after receiving the treatment, and was also intended to measure how the drug moved through the body over time. The reported data shows that, for the primary outcome — the number of participants who experienced treatment-related adverse events — 6 out of 7 people in the lower-dose group, 7 out of 7 in the higher-dose group, and 1 out of 4 in the placebo group had such events recorded. These events were assessed using a standard medical checklist called CTCAE v5.0. It is important to note that recording an adverse event does not on its own indicate whether it was serious or minor — only that it was noted and attributed to treatment. For all of the secondary outcomes — which were intended to measure things like how quickly the drug reached its peak level in the blood, what that peak level was, how long it stayed in the body, and how it spread through the body — the reported data shows that no results were submitted to ClinicalTrials.gov. These figures are simply not available in the data as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05552508 · results posted 25 March 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05552508) enrolled 45 people who were all given a medicine called benralizumab. Of those, 42 completed the study and 3 did not. There was only one group — everyone received the same treatment — so there was no comparison group. The trial was measuring changes in the airways over 13 weeks, using a specialised type of lung imaging to look at things like mucus (sticky fluid that can block airways), air trapping (air getting stuck in the lungs), and the size of the airways. The reported data shows the following changes from the start of the study to 13 weeks later. For the main (primary) measure — the total volume of mucus in the airways as measured at full lung capacity — several measurements were reported, all showing small reductions ranging from around −0.006 mL to −0.182 mL. For the secondary measures: the mucus plug score (a system that counts how many of the 18 main airway segments contain a full blockage, where higher numbers mean more blockages) showed a reported average reduction of 11.0 points. The amount of air trapping in the lungs showed a reported reduction of 0.141 percentage points. The volume of the walls of the smaller airways decreased by a reported 0.939 mL. Two measures of the space inside the smaller airways showed reported increases of 1.122 mL and 0.508 mL respectively. These numbers represent changes within a single group of participants; because there was no separate comparison (control) group in the data as reported, it is not possible from these figures alone to say how much of any change may have been due to the medicine itself. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04728711 · results posted 17 February 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04728711) enrolled 8 people with asthma, split into two groups of 4. It was a crossover study, meaning each person received both the investigational drug ADX-629 and a placebo (a dummy treatment) at different times. Seven of the 8 participants completed the study; one person in the "placebo first" group did not finish. The trial was measuring serious unwanted health events (called serious adverse events) as its main focus, and also tracked asthma control, and levels of certain immune cells in mucus samples collected after participants were exposed to an allergen through their airways. The reported data shows that for the primary (main) outcome — the number of participants who experienced a serious adverse event — zero participants had such an event in either the ADX-629 group or the placebo group. For the secondary (additional) outcomes, the reported data shows the following numbers: on the Asthma Control Questionnaire (scored 0–6, where lower means better control), the average change from the starting score was −0.20 for ADX-629 and −0.05 for placebo. Regarding a type of immune cell in mucus called eosinophils, the reported change at 7 hours after allergen exposure was +6.4% for ADX-629 and +11.6% for placebo, and at 24 hours was +0.1% for ADX-629 and +16.2% for placebo. For another immune cell type called neutrophils, the reported change at 7 hours was −8.5% for ADX-629 and +4.3% for placebo, and at 24 hours was +3.2% for ADX-629 and +7.8% for placebo. It is worth noting that this was a very small trial with only 8 participants, and the results as reported on ClinicalTrials.gov reflect that limited scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04718103 · results posted 29 November 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04718103) enrolled 263 people in the GSK3511294 group and 134 people in the placebo (dummy treatment) group, with 233 and 117 respectively completing the full 52 weeks. The trial was measuring how often participants had serious asthma flare-ups over one year, as well as several other things including quality of life, asthma symptom control, lung function (how much air a person can forcefully breathe out in one second), and daily and nightly symptom scores. The reported data shows that, for the main measure — serious asthma flare-ups over 52 weeks — the GSK3511294 group had an average of 0.56 flare-ups per person per year, compared with 1.08 in the placebo group. For the secondary measures at 52 weeks: on a quality-of-life questionnaire scored 0 (best) to 100 (worst), both groups improved from their starting scores, with the GSK3511294 group reporting a drop of about 14.8 points and the placebo group a drop of about 12.5 points. On an asthma symptom control questionnaire scored 0 (best) to 6 (worst), the GSK3511294 group improved by 0.81 points and the placebo group by 0.70 points. Lung function (air breathed out in one second) increased by 0.240 litres in the GSK3511294 group and 0.184 litres in the placebo group. On the daytime and nighttime symptom diaries (each scored 0–10, where higher means worse), both groups reported reductions, with the GSK3511294 group showing slightly larger decreases (around 1.13–1.18 points) compared to the placebo group (around 0.93–0.97 points). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03032159 · results posted 1 November 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03032159) involved 221 participants split into two groups — 110 people in the Control Group and 111 people in the Text2Breathe Study Group. The trial was looking at a text message-based program (Text2Breathe) for parents of children with asthma, and it measured things like how often children visited the emergency department for asthma, how many days they experienced asthma symptoms, how often they saw their regular doctor for asthma care, and how well parents understood asthma self-management and felt confident communicating with healthcare providers. By the end of the study, 91 people in the Control Group and 77 in the Text2Breathe group had completed the trial. The reported data shows that, for the main outcome — emergency department visits for asthma — the Control Group averaged 1.65 visits, while the Text2Breathe group averaged 1.95 visits over the study period. For asthma symptom days (a measure of how many days or nights children experienced impairment from asthma), the Control Group reported an average of 3.36 days and the Text2Breathe group reported an average of 4.45 days. The reported data also shows that the Text2Breathe group had a higher average number of scheduled doctor visits for asthma care (2.80 visits) compared to the Control Group (2.07 visits). For the additional measures, the reported data shows that scores on the asthma self-management knowledge questionnaire (rated 0–100, where higher means more knowledge) were similar between the two groups — 59.68 for the Control Group and 58.67 for the Text2Breathe group. Scores measuring how confident parents felt communicating with healthcare providers were also very close — 78.72 for the Control Group and 78.63 for the Text2Breathe group. Results for the measure of parental expectations about their child's asthma treatment were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05036733 · results posted 23 October 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all of whom completed the study — none dropped out. All 15 received the medication dupilumab. The trial was measuring how the community of bacteria living in the airways (called the respiratory microbiota) changed over time while participants were taking dupilumab. To do this, researchers collected sputum (mucus coughed up from the lungs) at three points: before starting the medication (baseline), after 1 month, and after 4 months. They used two different ways of measuring the bacterial community — one looking at variety *within* a single sample at a given time point, and one looking at how different the community was *between* two time points. The reported data shows the following numbers. For the first measure — called the Shannon Diversity Index, which captures how many different types of bacteria are present and how evenly spread they are (a higher number means more variety, zero means only one type) — the reported change from baseline to 1 month was +0.13, from baseline to 4 months was +0.14, and from 1 month to 4 months was −0.09. For the second measure — called the Bray-Curtis Distance, which runs from 0 to 1 and shows how different the bacterial community looked between two time points (a score closer to 1 means the communities looked very different from each other) — the reported scores were 0.82 between baseline and 1 month, 0.82 between baseline and 4 months, and 0.81 between 1 month and 4 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05791565 · results posted 23 September 2024

  According to the results reported on ClinicalTrials.gov, this trial involved 28 people in total, split into two groups of 14. It was a "crossover" study, meaning everyone tried both versions of a salbutamol inhaler — one using a propellant called HFA-152a and one using the more traditional propellant HFA-134a — with a washout break of at least 72 hours in between. The trial was mainly measuring how much of the medicine salbutamol entered the bloodstream and how quickly, by taking blood samples and tracking the drug's levels over time. One participant did not complete the washout period and did not continue to the second treatment phase. The reported data shows the following numbers for how salbutamol moved through the body. For the amount of drug in the bloodstream in the first 30 minutes after the dose, the HFA-152a inhaler recorded 0.622 and the HFA-134a inhaler recorded 0.536 (measured in units of hour×nanogram per millilitre — essentially a way of tracking the total drug exposure over time). Looking at total drug exposure across the full measurement period, the HFA-152a inhaler recorded 19.0 and the HFA-134a inhaler recorded 13.7 in the same units, and when extended out to account for remaining drug in the body, those figures were 21.1 and 15.0 respectively. The peak level of salbutamol detected in the blood was reported as 2.36 ng/mL for the HFA-152a inhaler and 1.80 ng/mL for the HFA-134a inhaler. The time taken to reach that peak level was reported as 2.00 hours for HFA-152a and 1.50 hours for HFA-134a. The reported data also shows how long it took for the drug level to fall by half: approximately 7.65 hours for HFA-152a and 7.30 hours for HFA-134a. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03562195 · results posted 19 September 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03562195) enrolled 300 people with asthma — 149 received mepolizumab (100mg) and 151 received a placebo (a dummy treatment with no active ingredient). The trial ran for 52 weeks and was primarily measuring how often participants experienced serious asthma flare-ups — defined as episodes bad enough to need steroid tablets, a hospital visit, or an emergency department visit. The reported data shows that, on average, people in the mepolizumab group had 0.45 such flare-ups per year, compared with 1.31 per year in the placebo group. For the secondary measures, the trial also tracked the likelihood of having a first flare-up at three points in time. By week 16, the reported probability was around 14% in the mepolizumab group versus about 35% in the placebo group; by week 32, around 18% versus 48%; and by week 52, around 28% versus 54%. Regarding hospitalisations specifically (without counting emergency department visits alone), 3 people in the mepolizumab group had one hospitalisation compared with 10 in the placebo group, and no one in the mepolizumab group had three hospitalisations compared with one person in the placebo group. The trial also measured lung function (how much air participants could breathe out in one second) and quality of life using a standard questionnaire. The reported data shows the mepolizumab group had an average improvement in lung function of about 263 millilitres versus about 126 millilitres in the placebo group, and quality-of-life scores improved by an average of about 14 points in the mepolizumab group versus about 7 points in the placebo group (on a scale where a lower score means better health). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04908384 · results posted 21 June 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04908384) involved children with asthma and their parents, split into two groups: one that received the IMPACT intervention and one that received usual care. A total of 21 children and 21 parents started in the intervention group, and 31 children and 31 parents started in the usual care group. The trial was measuring two main things: how responsibility for asthma management was shared between parents and children, and how confident (self-efficacious) both parents and children felt in managing asthma — tracked at the start of the study, at 8 weeks, and at 16 weeks. A breathing test (spirometry) was also used as a secondary measure. The reported data shows that for the responsibility questionnaire (scored 1–5, where 3 means parent and child share responsibility equally), scores across all groups sat close to the midpoint throughout the study. At 8 weeks, intervention children scored 2.72, intervention parents scored 2.72, control children scored 2.79, and control parents scored 2.31. At 16 weeks, those figures were 2.88, 2.63, 2.90, and 2.40 respectively. For the self-confidence (self-efficacy) questionnaire (also scored 1–5, with higher meaning more confident), scores at 8 weeks were: intervention children 3.79, intervention parents 4.27, control children 3.74, and control parents 4.41. At 16 weeks, those figures were 3.69, 4.36, 3.49, and 4.52. For the breathing test, intervention children scored 85.18% at 8 weeks and 85.38% at 16 weeks, while control children scored 82.87% and 81.82% at those same time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04981717 · results posted 11 June 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 446 people — 222 in the placebo group and 224 in the REGN1908-1909 group. The trial was measuring symptoms related to what appears to be an allergic condition, comparing a medicine called REGN1908-1909 against a placebo (an inactive treatment). The main thing being measured was a combined daily score that added together how severe a person's symptoms were and how much symptom-relieving medication they needed, known as the Combined Symptom and Medication Score (CSMS), on a scale from 0 (no symptoms or medication) to 38 (most severe). A number of secondary measures looked at specific nasal symptoms such as congestion, itching, runny nose, and sneezing. The reported data shows that the vast majority of participants — 214 in the placebo group and 220 in the REGN1908-1909 group — did not complete the trial, with only 8 and 4 people completing it in each group respectively. Regarding the actual outcome scores, no numerical results were reported in the data submitted to ClinicalTrials.gov for any of the measures — neither the primary CSMS score nor any of the secondary symptom scores. This means the specific numbers for these outcomes are not available to describe. Because no outcome measurement data was reported, it is not possible to describe what the scores showed for either group. If you are interested in the full findings of this trial, it may be worth checking whether results have been published elsewhere, such as in a medical journal. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02062463 · results posted 22 March 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02062463) had two stages. In Stage 1, around 485 people took part in a crossover comparison of two inhaler devices — an empty Spiromax and an empty Turbohaler — to see how easily people could learn to use them correctly through a step-by-step training process. In Stage 2, 197 people used a budesonide/formoterol (BF) Spiromax inhaler and 197 used a Symbicort Turbohaler over 12 weeks, to see how many could continue using the devices correctly after that time. The reported data shows that in Stage 1, 94.4% of participants reached what the trial called "device mastery" (meaning a trained healthcare professional observed no errors in their technique) with the Spiromax, compared with 86.9% for the Turbohaler, both achieved by the end of the third training step. When looking at how quickly people picked up correct technique, 33.3% of participants used the Spiromax correctly right away with no training at all, compared with 11.4% for the Turbohaler. After just reading the device information leaflet, those figures rose to 80.2% for Spiromax and 64.0% for Turbohaler. The median number of training steps needed was reported as 1 for Spiromax and 2 for Turbohaler, and the average number of observed errors was 1.91 for Spiromax and 2.36 for Turbohaler. The reported data for Stage 2 shows that after 12 weeks of real-world use, 58.9% of participants in the BF Spiromax group were still using the device with no observed errors, compared with 53.2% in the Symbicort Turbohaler group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02910401 · results posted 9 January 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02910401) enrolled three groups of participants: 6 people with asthma, 17 people with allergic rhinitis (hay fever), and 15 healthy volunteers — 38 people in total. The study was looking at what happens when participants were exposed to rhinovirus (the common cold virus), specifically measuring the symptoms they experienced afterwards, such as a blocked nose, nasal discharge, cough, and facial pain or pressure. Not everyone finished the study — 1 person in the asthma group and 2 in the healthy volunteer group did not complete it, while all 17 people in the allergic rhinitis group did. The reported data shows that symptoms were tracked using a scoring system called the Jackson criteria, where participants rated four symptoms (nasal discharge, congestion, cough, and pain/pressure) twice a day on a scale from 0 (none) to 3 (severe), giving a possible daily total of 0 to 24. According to the results reported on ClinicalTrials.gov, the average overall symptom scores recorded were 5.0 for the asthma group, 4.2 for the allergic rhinitis group, and 2.8 for the healthy volunteer group. No further breakdown of the scores over the four-week period was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01803555 · results posted 8 December 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 605 people in total — 303 in the BF Spiromax group and 302 in the Symbicort Turbohaler group. The trial was comparing these two inhaler treatments over 12 weeks in people with asthma. The main thing being measured was a breathing test called Peak Expiratory Flow (PEF) — essentially how fast a person can breathe out forcefully — recorded by participants each morning before taking their medication. Changes in evening PEF readings, adverse events (unwanted medical occurrences during the trial), and signs of oral thrush (a fungal mouth infection sometimes associated with inhaled medicines) were also tracked. The reported data shows that, on average, morning PEF improved from the starting point by about 18.8 litres per minute in the BF Spiromax group and about 21.8 litres per minute in the Symbicort Turbohaler group over the 12-week period. For evening PEF readings, the reported improvements were similar — around 18.7 litres per minute for BF Spiromax and 21.7 litres per minute for Symbicort Turbohaler. Regarding adverse events, the reported data shows that 117 out of 303 participants in the BF Spiromax group and 106 out of 299 participants in the Symbicort Turbohaler group experienced at least one adverse event during the study. For oral thrush, very small numbers of participants showed signs or positive swab results across both groups, with the totals across all recorded time points amounting to a handful of individuals in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01027143 · results posted 8 September 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT01027143) involved 98 children in total — 77 were given omega-3 fatty acids and 21 were in the control group (meaning they did not receive the omega-3 supplement). Of those who started, 68 in the omega-3 group and 17 in the control group completed the trial. The study was measuring asthma control in children, using several different tools including questionnaires, a breathing test, and blood and urine samples taken over the course of the trial. The reported data shows that on the main measure — the Asthma Control Questionnaire, which runs from 0 (best) to 6 (worst) — both groups started at similar scores (omega-3 group: 1.13; control group: 1.08). Scores in both groups changed very slightly over the study period, with the reported changes well below the 0.4-point threshold that the researchers described as a meaningful difference. On a second questionnaire (the Asthma Control Test, scored 5–25 where higher is better), scores were also similar across both groups at all time points, hovering around 19–20. The breathing test result — measuring how much air participants could breathe out forcefully in one second — was likewise similar between the two groups throughout the trial (roughly 90–92% of what would be expected for their age and size). The reported data also shows changes in the ratio of omega-3 to omega-6 fats measured in blood cells, with the omega-3 group showing a higher ratio by the end of the study compared to the control group. Urine measurements of a substance called leukotriene E4 (a marker measured from urine) were also recorded across time points for both groups, though the figures varied across the different measurement points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04589663 · results posted 27 July 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04589663) enrolled 24 adult participants, and all 24 completed the study with none dropping out. The trial was designed to compare how much of a medicine called mometasone furoate (an inhaled corticosteroid) entered the bloodstream when it was delivered by two different inhaler devices — an existing device called the Twisthaler, and a newer device called Concept 1 (which also contained a second medicine, indacaterol). Researchers measured the levels of these medicines in participants' blood at various time points to understand how the body absorbed them from each device. The reported data shows two main measurements for mometasone furoate in the blood. The first was the peak blood concentration (the highest level detected): this was reported as 51.9 pg/mL (pictograms per millilitre — a very small unit of measurement) for the Twisthaler device, and 53.5 pg/mL for the Concept 1 device. The second measurement was the total amount of the medicine in the blood over the first six hours after inhalation: this was reported as 208 h\*pg/mL for the Twisthaler and 176 h\*pg/mL for the Concept 1 device. For the second medicine in the Concept 1 inhaler, indacaterol, blood levels were also measured at several time points — the reported figures were 0 pg/mL (before the dose), 102.0 pg/mL, and 62.3 pg/mL at later time points. It is worth noting that the researchers applied a mathematical correction to all these figures to account for the fact that brand-new, first-use inhalers may deliver slightly less medicine than inhalers that have been used before. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03734861 · results posted 7 April 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 75 children in total — 50 in the BreatheSmart System group (a digital inhaler feedback tool) and 25 in the Standard of Care group (usual treatment without the device). All 75 participants completed the study. The trial was measuring how well children took their asthma medication over six months, along with several other things including asthma symptom control, a breathing test result, emergency room visits, and days missed from school. The reported data shows that for the main measure — medication adherence calculated using pharmacy refills — the BreatheSmart group covered an average of 0.39 (roughly 39%) of days with their medication, compared to 0.33 (roughly 33%) in the Standard of Care group. For the Asthma Control Test (a questionnaire scored from 5 to 25, where scores of 19 or below suggest poorly controlled asthma), both groups scored below 19 at the start of the study. By six months, the BreatheSmart group reported an average score of 21.2, while the Standard of Care group reported 20.0. The breathing test (which measures how much air someone can forcefully breathe out in one second, expressed as a percentage of what would be expected for a healthy person of the same age and size) showed the BreatheSmart group at 90.5% and the Standard of Care group at 103.6% at six months. For emergency room visits, the reported data shows 3 participants in each group had an ER visit over the study period. Average school days missed in the past 30 days at six months were reported as 2.1 days for the BreatheSmart group and 3.3 days for the Standard of Care group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02192827 · results posted 30 March 2023

  According to the results reported on ClinicalTrials.gov, this trial involved 308 children in total — 154 in each of two groups. Both groups received a steroid medicine called dexamethasone for the treatment of asthma symptoms in a hospital emergency department. One group received a single dose, while the other received two doses given one day apart. The trial was measuring whether patients came back for unplanned medical care after leaving the emergency department, how many days it took for symptoms to go away, and what side effects participants reported. The reported data shows that when it came to unplanned return visits to a doctor or emergency department, 14 out of 154 participants in the single-dose group and 12 out of 154 in the two-dose group had such a visit. For symptom resolution, the reported average was 2.4 days for the single-dose group and 2.5 days for the two-dose group. Side effects were also tracked — the numbers reported for individual side effects (such as vomiting, mood changes, appetite changes, sweating, and headache) varied between the two groups, though the trial report does not clearly label which specific number belongs to which side effect, so those individual breakdowns cannot be described in full detail here. It is also worth noting that 38 participants in each group did not complete the study, and the data does not report the reasons for this. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04545385 · results posted 13 March 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04545385) enrolled 65 people with asthma — 32 in the placebo group and 33 in the TEV-48574 group. The main thing the trial was measuring was how many participants experienced a "loss of asthma control" (LoAC) during the treatment period. This was defined as a meaningful drop in breathing ability on two days in a row, a big increase in the use of a reliever inhaler, a large increase in preventer medication, the need for steroid tablets, or an emergency department visit or hospital admission due to asthma. The trial also looked at several secondary measures, including how long it took for a loss of control to occur, changes in an asthma symptom score (rated 0–6, where higher means worse control), changes in a lung function test, changes in daily reliever inhaler use, and the number of people who had a more serious asthma flare-up. The reported data shows that 13 out of 31 people in the placebo group and 17 out of 33 in the TEV-48574 group experienced a loss of asthma control during the treatment period. For the time taken to reach that point, a figure was not reported for the placebo group, while the TEV-48574 group had a reported median of 109 days. On the asthma symptom score (0–6 scale), both groups improved from their starting point: the placebo group's score changed by −0.56 and the TEV-48574 group's by −0.83 (lower numbers mean better control). For the lung function measure, the placebo group showed a change of +0.12% predicted and the TEV-48574 group showed +4.84% predicted. Daily reliever inhaler use changed by −0.24 puffs per day in the placebo group and −0.31 puffs per day in the TEV-48574 group. Finally, 2 people in the placebo group and 3 people in the TEV-48574 group had a more serious clinical asthma flare-up during the treatment period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03706079 · results posted 9 February 2023

  According to the results reported on ClinicalTrials.gov, this trial (called DESTINATION) was a long-term follow-up study for people with asthma who had previously taken part in one of two earlier trials — NAVIGATOR or SOURCE. Participants had been randomly assigned in those earlier trials to receive either a medicine called tezepelumab or a placebo (a dummy treatment with no active ingredient). In total, across both earlier trials, over 1,200 people started the predecessor phase, and hundreds then continued into the long-term follow-up. The study was tracking how often participants experienced adverse events (unwanted health events that occurred during the study period) and how often asthma flare-ups (called exacerbations) happened. The reported data shows that the primary outcome — the rate of adverse events adjusted for how long each person was in the study — was measured as the number of patients experiencing such events per 100 person-years (a way of accounting for different lengths of follow-up). For participants from the NAVIGATOR trial who had been on tezepelumab, this figure was reported as approximately 49.6, compared with approximately 62.7 for those who had been on placebo. For participants from the SOURCE trial, the figures were approximately 47.2 (tezepelumab group) and approximately 70.0 (placebo group). Serious adverse events were also reported separately at lower rates across all groups, though the exact breakdown across all sub-categories is complex. For the secondary outcome — the yearly rate of asthma flare-ups — the reported data shows approximately 0.82 events per year in the NAVIGATOR tezepelumab group versus 1.93 in the NAVIGATOR placebo group, and approximately 1.07 versus 1.76 in the SOURCE tezepelumab and placebo groups respectively. It is important to note that these figures simply describe what was recorded and counted during the study period for the people who took part. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02545998 · results posted 8 February 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 88 people in total — 44 in a standard face-to-face asthma care group and 44 in a telehealthcare (remote/digital care) group. The trial was measuring how the two approaches compared across several areas, including how patients felt about their care experience, their quality of life, how well their asthma was controlled, how long appointments took, how many people dropped out, and whether participants had any asthma flare-ups in the six months after their review. The reported data shows that, by the end of the study, 29 people in the standard care group and 39 people in the telehealthcare group completed the trial. For the main outcome — overall patient experience, scored out of 400 (where 400 is the best possible score) — the standard care group recorded a median score of 390 and the telehealthcare group recorded 400. On the secondary measures: 11 people dropped out of the standard care group compared to 2 in the telehealthcare group; average appointment length was reported as 20 minutes for standard care and 15 minutes for telehealthcare. Both groups scored 6.4 out of 7 on the asthma quality-of-life questionnaire at six months. Asthma control scores at six months were 24 out of 25 for the standard care group and 23 out of 25 for the telehealthcare group. The reported number of asthma flare-ups in the six months following the review was zero in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02230189 · results posted 16 August 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 28 people across three groups: 22 people with allergic asthma, 2 people with allergic conditions but no asthma, and 4 people without allergies or asthma. Of those who started, 17 allergic asthma participants, 2 allergic non-asthma participants, and 3 non-allergic non-asthma participants completed the study. The trial was a mechanistic study — meaning it was designed to understand what is happening in the body at a biological level, not to test a treatment. Specifically, it looked at tiny molecules called miRNAs (microRNAs) in the cells lining the airways, to see whether these molecules changed after a small, controlled dose of allergen was introduced directly into one part of the lung, compared to a harmless saltwater solution (diluent) introduced into another part. The reported data shows that in the allergic asthma participants, the researchers measured the activity levels of several specific miRNAs — recorded as normalised log2 copy numbers, which is simply a scientific unit for measuring how much of a molecule is present — at two time points: 24 hours after the challenge, and again at 7 days after the challenge. At 24 hours, the reported values across the six measured miRNAs ranged from roughly 7.02 to 9.63 in the allergen-exposed lung segment, and from roughly 6.56 to 9.01 in the diluent-exposed segment. At 7 days, the reported values ranged from approximately 5.03 to 14.14 in the allergen segment, and from approximately 5.83 to 12.73 in the diluent segment. The researchers noted that the direction of any change in these numbers does not carry direct clinical meaning, as this was a study aimed at understanding biological processes rather than measuring patient outcomes. The reported data does not include further detail on what these specific numerical differences mean in a broader health context, and no treatment outcomes were measured or reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01397162 · results posted 23 June 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT01397162) enrolled 29 people in total across five groups: a placebo group (8 people), three groups receiving different doses of an investigational inhaler called BI 54903 (5, 4, and 6 people respectively), and a group receiving a comparator inhaler called fluticasone propionate (6 people). The trial ran for 8 weeks and was measuring changes in lung function — specifically how much air participants could breathe out — in people with asthma. Very few participants completed the study: only 1 person finished in each of the four smaller groups, and 3 in the fluticasone group. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — neither the primary measure (change in how much air participants could forcefully breathe out in one second, measured before their morning dose) nor any of the secondary measures (which included other breathing tests and records of how often participants used their rescue inhaler). All of these data fields were left empty in the submitted results. Because the trial had very low completion numbers and no outcome data was reported, the reported data shows there are no figures available to describe for any of the measured outcomes across any of the five groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01092143 · results posted 31 May 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 389 people across five groups to compare different doses of an investigational medicine called BI 671800 against both a placebo (a dummy treatment with no active ingredient) and an established inhaled steroid called fluticasone, in people with asthma. The five groups were: placebo (78 people), BI 671800 at 50 mg twice daily (77 people), BI 671800 at 200 mg twice daily (84 people), BI 671800 at 400 mg twice daily (79 people), and fluticasone at 220 mcg twice daily (71 people). The trial ran for six weeks and measured lung function and asthma symptom control. The reported data shows that the main thing being measured was a lung function test called FEV1 — essentially how much air a person can forcefully breathe out in one second, expressed as a percentage of what would normally be expected for someone of their age and size. After six weeks, the reported change from the starting point was: placebo group, a decrease of 2.01 percentage points; BI 671800 50 mg group, an increase of 1.07 points; BI 671800 200 mg group, an increase of 1.58 points; BI 671800 400 mg group, an increase of 1.97 points; and the fluticasone group, an increase of 6.61 points. The reported data also shows results for a second measure — a seven-question asthma symptom questionnaire scored from 0 (well controlled) to 6 (extremely poorly controlled). After six weeks, all groups showed a reduction in score from their starting point, meaning symptoms moved in a lower (more controlled) direction. The reported changes were: placebo, −0.62; BI 671800 50 mg, −0.54; BI 671800 200 mg, −0.70; BI 671800 400 mg, −0.68; and fluticasone, −0.95. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01997463 · results posted 23 March 2022

  According to the results reported on ClinicalTrials.gov, this trial involved two groups of participants with asthma: 192 people in a "Regular Therapy" group and 250 people in a "Supervised Therapy" group, giving a total of 442 participants at the start. The trial was measuring asthma control using a tool called the Juniper Asthma Control Questionnaire (ACQ) — a scoring system where a score above 1.5 suggests asthma is not well controlled, and a score of 1.5 or below suggests it is well controlled. The reported data shows the number of participants falling into different ACQ score categories at various points during the study. Across the measurement time points reported, the numbers of participants recorded with ACQ scores varied — for example, figures ranging from 54 to 75 participants were recorded at different time points in the Regular Therapy group, and from 70 to 99 in the Supervised Therapy group. It is worth noting that not all participants who started the trial completed it: 85 people in the Regular Therapy group and 103 in the Supervised Therapy group did not finish. The data does not include average ACQ scores or a breakdown of how many participants fell above or below the 1.5 threshold at each time point, so those specific comparisons were not reported in the structured results submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04613739 · results posted 9 March 2022

  According to the results reported on ClinicalTrials.gov, this trial looked at an "insurance navigation" programme — a service designed to help people find and enrol in health insurance coverage. A total of 56 people took part: 19 were placed in the Insurance Navigation group and 37 in a wait-list control group (people who waited rather than receiving the programme straight away). The trial focused on adults managing asthma and measured whether the programme made a difference to their insurance coverage, their ability to afford and stick to their asthma medications, and whether cost stopped them from seeking care or paying medical bills. By the end, 12 people in the navigation group and 25 in the wait-list group had completed the study. The reported data shows the following numbers at the end of the study period. For insurance coverage, 11 out of 12 completers in the navigation group had some form of insurance, compared with 17 out of 25 in the wait-list group; 1 person in the navigation group and 8 in the wait-list group had no coverage. On the question of using less asthma medication than prescribed because of cost, 3 people in the navigation group reported doing this, compared with 8 in the wait-list group (with 9 and 17 respectively reporting they did not). For financial burden — meaning trouble paying medical bills or needing to borrow money for asthma care — 5 people in the navigation group reported this, versus 15 in the wait-list group. Regarding delayed or avoided care due to cost, 4 people in the navigation group reported this, compared with 13 in the wait-list group. The data as submitted does not include further statistical analysis figures (such as confidence intervals or p-values) beyond these participant counts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01902290 · results posted 28 February 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT01902290) enrolled 210 people in the placebo group and 211 people in the brodalumab 210 mg group, for a total of 421 participants. The trial ran for 24 weeks and was primarily measuring changes in asthma control using a standardised questionnaire called the Asthma Control Questionnaire (ACQ), which scores asthma symptoms on a scale from 0 (fully controlled) to 6 (extremely poorly controlled). A lower score over time means fewer reported symptoms, and a drop of at least 0.50 points on this scale is considered meaningful. The reported data shows that both groups had lower ACQ scores at 24 weeks compared to where they started — meaning both groups reported fewer asthma symptoms on average. The placebo group's score dropped by 0.815 points, while the brodalumab group's score dropped by 0.865 points. For asthma flare-ups (episodes serious enough to need steroid treatment for at least three days), the placebo group had a reported rate of 0.57 flare-ups per person per year, while the brodalumab group had a reported rate of 0.81 flare-ups per person per year. Similar patterns were seen in a smaller subgroup of participants who were also taking a combination of two inhaler medicines. The reported data also shows small reductions in daily symptom diary scores and small improvements in a breathing test (measuring how much air a person can forcefully breathe out in one second) in both groups, with the brodalumab group going from 0.207 litres improvement in the placebo group to 0.237 litres in the brodalumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04046939 · results posted 22 December 2021

  According to the results reported on ClinicalTrials.gov, this trial tested a drug called dexpramipexole in people with asthma who had raised levels of a type of white blood cell called eosinophils. The trial compared three different twice-daily doses of the drug (37.5 mg, 75 mg, and 150 mg) against a placebo (a dummy treatment with no active ingredient). A total of 534 people entered the initial screening phase, 144 went through a run-in period receiving placebo only, and 103 were eventually split across the four groups for the main 12-week treatment period — 27 in the placebo group, 22 in the 37.5 mg group, 26 in the 75 mg group, and 28 in the 150 mg group. The main thing being measured was the change in the number of eosinophils in the blood after 12 weeks. The reported data shows that eosinophil counts changed in all four groups over the 12 weeks, expressed as a ratio compared to where each participant started (a ratio of 1.0 would mean no change). The placebo group's count sat at roughly 0.90 of their starting level, meaning a small reduction. The three dexpramipexole groups showed ratios of approximately 0.40, 0.31, and 0.21 for the 37.5 mg, 75 mg, and 150 mg doses respectively, meaning the counts were reported as lower compared to baseline, with the largest numerical difference seen at the highest dose. For the secondary measures, lung function (the amount of air forcibly breathed out in one second) showed reported changes ranging from small to modest across all groups. Asthma control questionnaire scores and quality-of-life scores also shifted across all groups, including the placebo group. For a blood test looking at potentially significant changes in blood cell counts, zero participants in the placebo, 37.5 mg, and 75 mg groups met those criteria for most measures, while 1–2 participants in the 150 mg group were flagged on one measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03347279 · results posted 26 November 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03347279) enrolled 1,061 adults and adolescents with uncontrolled asthma — 529 assigned to receive tezepelumab (210 mg every four weeks) and 532 assigned to receive a placebo (an inactive injection). The trial ran for 52 weeks and was primarily measuring how often participants had asthma flare-ups (called exacerbations) over the course of a year. It also looked at lung function, asthma control, quality of life, and daily symptom scores. The reported data shows that, for the overall group, the tezepelumab group had a reported average of 0.93 flare-ups per year, compared with 2.10 per year in the placebo group. Among participants who had a lower level of a particular type of blood cell (eosinophils below 300 cells per microlitre — a measure sometimes used to categorise asthma type), the reported figures were 1.02 flare-ups per year for tezepelumab and 1.73 for placebo. For lung function, the tezepelumab group showed a reported average improvement of 0.23 litres in the amount of air they could forcefully breathe out in one second, compared with 0.10 litres in the placebo group. On a quality-of-life questionnaire scored from 1 to 7 (higher meaning better), the reported average score improvement was 1.48 for tezepelumab versus 1.14 for placebo. On an asthma control scale of 0 to 6 (lower meaning better control), scores changed by −1.53 for tezepelumab and −1.20 for placebo. On a daily symptom diary scored 0 to 4 (lower meaning fewer symptoms), changes were −0.70 for tezepelumab and −0.59 for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03705273 · results posted 8 November 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03705273) involved 40 participants in total, split evenly into two groups of 20. One group received dexamethasone in tablet form, and the other received a dexamethasone solution made from an intravenous (IV) preparation given by mouth (sometimes called "IV for PO"). All 40 participants completed the trial with no dropouts. The trial was measuring nausea after taking the medication, as well as whether participants needed a second dose — for example, because they vomited or spat out the first one. The reported data shows that, for the primary outcome of nausea after taking the medication, 3 out of 20 participants in the tablet group reported experiencing nausea, while 0 out of 20 participants in the liquid solution group reported nausea. For the secondary outcome — how many participants needed a second dose of dexamethasone — the reported data shows 0 out of 20 in the tablet group and 0 out of 20 in the liquid solution group required a repeat dose. No other outcome data appears to have been reported in the structured results submitted to ClinicalTrials.gov, so no further figures are available beyond those described above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03187119 · results posted 22 October 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03187119) enrolled 45 children with asthma and their parents — 22 in a group given a **pictorial asthma action plan** (one that uses images) and 23 in a group given a **written asthma action plan** (text-based). Of those who started, 20 and 18 participants respectively completed the study. The trial was measuring how well children and parents understood their asthma action plan, how well asthma was being controlled, how consistently participants used their daily preventer inhaler, and how their lungs were functioning over time. The reported data shows the following numbers across the main outcomes: - **Knowledge about the asthma action plan (children):** Children in the pictorial group scored an average of about 76–77% correct on a knowledge quiz, while children in the written group scored about 61–62% correct, across the time points measured. - **Knowledge about the asthma action plan (parents):** Parents in the pictorial group scored around 64–74% correct, and parents in the written group scored around 66–70% correct. - **Asthma control:** The trial tracked how many participants fell into a "poor control" category (a score of 19 or below on a standard asthma questionnaire). The reported data shows the counts of participants above and below that cut-off at several time points, but a summary figure for each group was not reported in a way that allows a straightforward single comparison. - **Daily inhaler use:** The reported data shows the percentage of prescribed doses taken on certain days. Figures varied considerably across time points and between groups — for example, ranging from 0% to 100% on individual measurement days — suggesting the numbers fluctuated a great deal. The trial notes that the final time point (day 180) was not included due to too few participants remaining. - **Lung function (breathing tests):** Average lung function scores were reported at two time points. For the main breathing measure (FEV1), the pictorial group recorded averages of about 2.60 and 2.68, and the written group about 2.39 and 2.66. For a related airflow measure (FEF 25–75), figures were similarly close between the two groups across time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02948959 · results posted 20 October 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 408 participants in total — 135 received a placebo (an inactive treatment used for comparison) and 273 received dupilumab, a medicine being studied for asthma. The trial ran for 52 weeks and was primarily measuring how often participants had severe asthma flare-ups (episodes serious enough to need steroid tablets for three or more days, or a hospital or emergency visit). Two specific groups within the trial were tracked separately: people whose blood showed higher levels of a certain immune cell called eosinophils (300 or more per microlitre), and people classed as having a "Type 2 inflammatory" pattern of asthma — a way of categorising asthma based on certain markers in the blood and breath. The reported data shows that, for the higher-eosinophil group, the placebo group had an average of 0.665 severe flare-ups per person per year, compared with 0.235 in the dupilumab group. In the Type 2 inflammatory group, the placebo group averaged 0.748 flare-ups per person per year, compared with 0.305 in the dupilumab group. On the secondary outcomes, lung function was also measured — specifically how much air a person can breathe out forcefully in one second (called FEV1). By week 12, the reported improvement in the higher-eosinophil group was around 4.83 percentage points for placebo and 10.15 for dupilumab; in the Type 2 group, it was 5.32 versus 10.53 percentage points. Asthma symptom control was tracked using a questionnaire scored from 0 (fully controlled) to 6 (severely uncontrolled), where a lower score means better control. By week 24, scores in the higher-eosinophil group dropped by 0.88 points in the placebo group and 1.34 points in the dupilumab group; in the Type 2 group, the drops were 0.99 and 1.32 points respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02566902 · results posted 6 May 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 118 children who came to an emergency department with breathing difficulties (60 in one group, 58 in the other). The study compared two different types of nebuliser devices — a standard T-piece nebuliser and a breath-enhanced nebuliser — both used to deliver a single dose of albuterol sulfate (a common reliever medicine). The main thing being measured was the change in a lung function test called FEV1 (how much air a person can forcefully breathe out in one second, expressed as a percentage of what would be expected for someone their age and size), taken before and 10 minutes after the treatment. The reported data shows that lung function scores changed by an average of 13.8 percentage points in the T-piece group and 9.1 percentage points in the breath-enhanced group. For two separate symptom scoring scales used by clinicians (the PAS and PASS scores, which rate things like breathing rate, wheezing, and effort to breathe on numbered scales), the reported data shows small reductions in both groups — for example, PAS scores fell by 1 point in the T-piece group and 2 points in the breath-enhanced group, while PASS scores fell by 1 point in both groups. The reported data also shows that 11 participants in each group were admitted to hospital, and the average time spent in the emergency department was almost identical — about 246 minutes in both groups. Regarding reported side effects (such as nausea, vomiting, or palpitations), 5 participants in each group were recorded as experiencing them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02808819 · results posted 13 April 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02808819) enrolled 446 people in total — 220 in a group receiving a medicine called benralizumab (referred to here as "Benra") every 4 weeks, and 226 receiving the same medicine every 8 weeks. By the end of the study, 189 and 195 people in each group respectively had completed it, with 31 people in each group not finishing. The trial was focused on measuring changes in blood cell counts — specifically several types of cells found in the blood — to understand how the body's blood profile changed over the course of treatment. The reported data shows the following average changes in blood cell levels (measured in billions of cells per litre of blood) from the start of the study to the end. For white blood cells overall (leukocytes), the count went down by an average of 0.254 in the 4-weekly group and 0.498 in the 8-weekly group. A specific type of white blood cell called neutrophils also decreased, by 0.237 and 0.392 respectively. Lymphocytes (another white blood cell type) decreased by 0.098 and 0.142. Basophils (yet another white blood cell type) showed a small increase of 0.014 and 0.012. Monocytes (a further white blood cell type) increased slightly by 0.055 in both groups. Platelets — the cells involved in clotting — increased by an average of 9.1 in the 4-weekly group and 11.9 in the 8-weekly group. It is important to note that this summary only describes the numbers as recorded — it does not indicate whether these changes are meaningful, expected, or unusual in the context of treatment. No secondary outcome data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02782065 · results posted 16 February 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 58 children with asthma, and all 58 completed the study. The trial was not testing a medication — instead, it was comparing two scoring tools that healthcare providers use to rate how severe a child's asthma episode appears to be. The two tools were the Hospital Asthma Severity Score (HASS) and the Pediatric Respiratory Assessment Measure (PRAM). The study looked at how consistently different clinicians agreed with each other when using these tools, and how well the tools lined up with a breathing test called FEV1 (which measures how much air a person can forcefully breathe out in one second). The reported data shows that when two different clinicians independently used the HASS on the same patient, they agreed with each other 29% of the time. For the PRAM tool, two clinicians agreed with each other 28% of the time. The study also looked at how well each clinician's HASS rating matched their own PRAM rating for the same patient (called "intra-rater" agreement, meaning agreement within a single rater). The reported figures for this were 71% for one rater and 64% when data from multiple second raters were combined. When the tools were compared against the FEV1 breathing test, the reported correlation figures (a measure of how closely two things move together, on a scale from -1 to +1) were -0.31 for the HASS and -0.30 for the PRAM. A negative number here indicates that higher severity scores on the tools tended to correspond with lower FEV1 readings, as would be expected, though the strength of that relationship as reported appears modest. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03528577 · results posted 22 January 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 128 participants and was carried out in four sequences (stages), with participants completing each sequence at different points throughout the study. The trial was measuring what is called "PC20" — this is the amount of a substance called methacholine needed to cause a noticeable drop in how much air a person can breathe out forcefully in one second. In other words, it was testing how sensitive participants' airways were after inhaling different doses of a medicine called albuterol (a common inhaler medicine, also known as salbutamol in Australia) or a dummy (placebo) inhaler. Most participants completed the trial, with only a small number — between one and three per sequence — not finishing. The reported data shows that the primary measurement was taken from a group called the "Primary Analysis Group," which included 114 participants. The specific PC20 result for this group was reported as a single figure, but the data submitted to ClinicalTrials.gov does not include the actual numerical value for that result — only the number of participants (114) in that analysis. No further breakdown of the PC20 numbers, nor results from any secondary outcome measures, appear to have been reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02134028 · results posted 2 November 2020

  According to the results reported on ClinicalTrials.gov, this long-term follow-up trial (NCT02134028) enrolled a total of 2,282 participants who had previously taken part in one of four earlier studies of dupilumab (a medicine being investigated for asthma). Participants were grouped depending on which earlier trial they came from and whether they had originally received dupilumab or a placebo (a dummy treatment) in that earlier trial before switching to dupilumab in this study. The trial was measuring a range of things, including how many people experienced unwanted medical events during the study period, and also tracked things like blood pressure, blood test results, the number of severe asthma flare-ups (episodes serious enough to need extra medication or hospital care), and a breathing test called FEV1 (which measures how much air a person can breathe out in one second). The reported data shows that the primary thing being tracked was the number of participants who experienced any medical event during the treatment period. Across the groups from the four parent studies, the numbers ranged widely — for example, in the largest group (from the EFC13579 study, who had been on dupilumab from the start), 789 out of 1,013 participants recorded at least one such event, while in the smallest group (PDY14192, dupilumab from the start), 13 out of 14 did. For the secondary outcomes, the reported data shows the number of severe asthma flare-up events ranged from 1 (PDY14192 dupilumab group) to 437 (EFC13579 dupilumab group), with annualised rates (that is, the average number of flare-ups per person per year) ranging from 0.077 to 0.391 across all groups. For the breathing test (FEV1), the reported data shows changes from participants' starting point ranged from around 0.01 to 0.36 litres across groups at week 48, and from 0.22 to 0.33 litres at week 96 in the groups where data was available. Some additional measurements — including certain blood pressure and blood test abnormalities — were reported in smaller numbers of participants across the groups, and not all group data was reported for every time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03393806 · results posted 23 October 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 17 people in total — 9 received a placebo (an inactive treatment) and 8 received the study drug, GSK3772847. All 8 participants in the GSK3772847 group completed the trial, while 8 of the 9 in the placebo group completed it. The trial was measuring two main things: changes in the number of eosinophils (a type of white blood cell linked to inflammation) in the blood, and changes in a measure called fractional exhaled nitric oxide, or FeNO — a reading taken from a person's breath that can indicate airway inflammation. The reported data shows that for blood eosinophil levels, the placebo group saw increases from their starting levels at early time points (for example, around +31% and +16%), while the GSK3772847 group also showed an early rise (+28%) but later recorded decreases (around −31% and −11% at later time points). For FeNO, the placebo group's readings went up early (roughly +33% and +14%) before eventually falling (around −37%), while the GSK3772847 group showed reductions across most time points measured (ranging from approximately −13% to −46%). For the secondary measures, the reported data shows that free ST2 levels (a protein in the blood) dropped to very low values in the GSK3772847 group compared to the placebo group, while total soluble ST2 levels rose substantially in the GSK3772847 group over time. Blood concentrations of GSK3772847 itself were also measured at various points and are reported in the data. No participants in either group tested positive for antibodies against GSK3772847 at any time point measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01951378 · results posted 2 September 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled children who came to an emergency department with acute asthma. A total of 40 children took part — 23 were assigned to receive treatment delivered through a Hudson RCI® nebuliser (a device that turns liquid medicine into a fine mist for breathing in), and 17 through a NebuTech® HDN® nebuliser. The trial was designed to compare how long children spent in the emergency department depending on which nebuliser was used, and also planned to look at things like how many children were admitted to hospital, whether they needed extra treatments, and whether they returned for unscheduled visits. The reported data shows that no numerical results were submitted for any of the outcome measures — including the main measure of time spent in the emergency department, or any of the secondary measures such as hospital admission rates or need for additional therapies. The data fields for all of these outcomes are empty in the results as lodged on ClinicalTrials.gov. It is also noted that none of the 40 enrolled participants were recorded as having "completed" the study, with all participants listed under "not completed," though no explanation for this is provided in the submitted data. Because no actual measurement figures were reported, it is not possible to describe what the trial found about any of its intended questions. The reported data shows only that the study ran as a pilot phase — meaning it was an early-stage effort intended partly to help plan a larger study — but the specific numbers that were meant to come from that process were not included in the ClinicalTrials.gov submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02555683 · results posted 18 May 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 894 adults with asthma across three groups: 301 people received a lower dose of the investigational medicine QAW039 (150 mg), 295 received a higher dose (450 mg), and 298 received a placebo (a dummy treatment with no active ingredient). The trial ran for 52 weeks and was primarily measuring how often participants had moderate-to-severe asthma flare-ups — meaning episodes serious enough to need several days of steroid medication, a hospital visit, or an emergency department visit. Results were reported both for all participants and for a subgroup of participants who had higher-than-normal levels of a type of white blood cell called eosinophils (a marker sometimes linked to a particular type of asthma). The reported data shows that, across all participants, the average rate of moderate-to-severe flare-ups per year was 0.92 in the 150 mg group, 0.75 in the 450 mg group, and 0.96 in the placebo group. In the higher-eosinophil subgroup, the reported rates were 0.97, 0.77, and 0.93 flare-ups per year for the 150 mg, 450 mg, and placebo groups respectively. For the secondary outcomes in the higher-eosinophil subgroup, the reported data shows changes in quality-of-life scores (on a 7-point scale, where higher is better) from the start to week 52 of +0.75, +0.81, and +0.68 for the 150 mg, 450 mg, and placebo groups. Asthma control scores (on a 0–6 scale, where lower means better control) changed by −0.88, −0.94, and −0.76 respectively. Lung function (measured as the volume of air a person can forcibly breathe out in one second) increased by 0.169, 0.153, and 0.103 litres in the same groups. Similar quality-of-life score improvements were reported across all participants: +0.68, +0.73, and +0.61. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02980133 · results posted 18 March 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02980133) enrolled 841 participants across four groups. Each group received a different inhaled treatment twice daily for 12 weeks: a placebo (inactive treatment), a low dose of fluticasone propionate (Fp MDPI 25 mcg), a higher dose of fluticasone propionate (Fp MDPI 50 mcg), or a combination of fluticasone propionate and salmeterol (FS MDPI 50/12.5 mcg). The trial was measuring changes in lung function — specifically how much air participants could forcefully breathe out — along with other measures such as peak airflow, asthma symptom scores, use of reliever medication (salbutamol/albuterol), and an asthma control questionnaire score for children. The reported data shows that for the main lung function measure (a morning breathing test taken one hour after a dose at week 12), the change from the starting point was reported as an improvement of 16.8 percentage points in the low-dose Fp group, 16.4 in the higher-dose Fp group, and 18.2 in the combination FS group. For a separate primary measure — a daily home-recorded morning breathing test averaged over the week at week 12 — the reported changes from baseline were 7.3 percentage points in the placebo group, 13.3 in the low-dose Fp group, and 14.2 in the higher-dose Fp group. For the secondary measures, the reported data shows that morning peak airflow (the speed of a forced breath out) increased from baseline by 12.3 litres per minute in the placebo group, 28.9 in the low-dose Fp group, 26.3 in the higher-dose Fp group, and 32.0 in the combination group. Changes in daily reliever inhaler use were small across all groups (ranging from −0.2 to −0.5 puffs per day). Asthma symptom scores on a 0–9 scale changed by −0.1 to −0.2 across all groups. The children's asthma control questionnaire (scored 0–27) showed changes of 4.5 points in the placebo group and approximately 5.1 to 5.5 points across the active treatment groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02333630 · results posted 11 March 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02333630) enrolled 200 people with asthma — 100 in the AsthmaCare group (who used a mobile health application) and 100 in a control group. The study ran over six months and was mainly measuring how often participants visited an emergency room due to asthma. It also looked at the number of asthma flare-ups, hospital admissions, and how frequently the app was used. The reported data shows that, on average, people in the AsthmaCare group had 0.31 emergency room visits for asthma over the six months, compared with 0.33 visits in the control group. For hospital admissions related to asthma, the AsthmaCare group averaged 0.14 admissions, while the control group averaged 0.10 admissions. Regarding the number of asthma flare-ups (measured by courses of a steroid medicine called prednisone that were prescribed) and how often participants used the app, the data for those two outcomes was not reported in the results submitted to ClinicalTrials.gov. By the end of the study, 95 out of 100 participants completed the AsthmaCare group, and 98 out of 100 completed the control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02924688 · results posted 21 February 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 2,436 people across six treatment groups, each receiving a different inhaled combination of medicines used in asthma management — some groups received two active ingredients (fluticasone furoate and vilanterol, abbreviated FF/VI) and others received three (fluticasone furoate, umeclidinium, and vilanterol, abbreviated FF/UMEC/VI, at two different doses of umeclidinium). The main thing the trial was measuring was a change in lung function — specifically how much air participants could forcefully breathe out in one second (called FEV1, measured in litres) — taken before their morning dose at 24 weeks. The trial also tracked asthma flare-ups, symptom scores, and quality of life over the same period. The vast majority of participants in each group completed the study. The reported data shows that, for the primary lung function measure at 24 weeks, all six groups showed an increase in FEV1 from their starting point. The two-ingredient groups (FF/VI) showed increases of 0.024 litres (lower steroid dose) and 0.076 litres (higher steroid dose). The three-ingredient groups showed larger reported increases, ranging from 0.120 to 0.168 litres in the lower steroid groups and 0.157 to 0.168 litres in the higher steroid groups. When lung function was measured three hours after taking the study treatment at week 24, the reported increases were larger across all groups, ranging from 0.132 litres (FF/VI lower dose) up to 0.286 litres (FF/UMEC/VI higher doses). For asthma flare-ups per year, the reported data shows 0.70 per year for the two-ingredient group, 0.68 for the lower-dose three-ingredient group, and 0.61 for the higher-dose three-ingredient group. The reported data shows that scores on three questionnaires — covering asthma control, quality of life related to breathing, and respiratory symptoms — all moved in a favourable direction from baseline across every group, though the numbers reported were broadly similar between groups. For example, the quality-of-life questionnaire (scored 0–100, where lower is better) changed by approximately −11 points in the two-ingredient group, −10 points in the lower-dose three-ingredient group, and −12 points in the higher-dose three-ingredient group; the trial notes that a change of 4 points is considered meaningful on that scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03215758 · results posted 12 February 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 339 people in the QAW039 (investigational medicine) group and 336 people in the placebo (dummy treatment) group — a total of 675 participants. The trial was measuring changes in lung function and asthma symptoms over 12 weeks. The main thing being measured was a lung function test called FEV1 — essentially how much air a person can forcefully breathe out in one second — comparing where participants started (their "baseline") to where they were at week 12. Secondary measurements included daytime asthma symptom scores, how often participants used their reliever puffer (called a SABA, or short-acting rescue inhaler), and a quality-of-life questionnaire score. The reported data shows that, for the primary lung function measure, the QAW039 group's FEV1 increased by an average of 0.112 litres from baseline, while the placebo group's increased by an average of 0.071 litres. For daytime asthma symptoms (scored 0–6, where higher means worse), both groups showed a reduction: the QAW039 group's score fell by 0.56 points on average, compared to 0.51 points in the placebo group. For reliever puffer use, the QAW039 group used an average of 1.11 fewer puffs per day, while the placebo group used 1.02 fewer puffs per day. For the quality-of-life questionnaire (scored 1–7, where higher means better quality of life), the QAW039 group's score rose by an average of 0.91 points, compared to 0.89 points in the placebo group. No data beyond these average change figures was reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03380429 · results posted 5 February 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 437 people across five groups, with between 86 and 88 participants starting in each group. Between 77 and 82 people in each group completed the full six months. All participants used an inhaler called ELLIPTA (brand names Relvar or Breo) for their respiratory condition, and a clip-on electronic sensor tracked each time the inhaler was opened and closed. The trial was measuring whether sharing that sensor data — with the patient, their doctor, or both — made any difference to how consistently people took their daily doses, compared to a control group where no data was shared with anyone. The reported data shows that, in the final two months of the study (months four to six), the group where both the patient and their doctor received the inhaler usage data took their doses on approximately 80.9% of days, while the group where no data was shared at all recorded approximately 69.0% of days. The secondary outcome results followed a similar pattern across the earlier and full study periods: groups that received some form of data feedback generally showed reported daily dose rates ranging from about 75% to 86%, while the no-data group consistently sat around 69–76%. For rescue inhaler use (a separate quick-relief puffer), the reported data shows that the percentage of days participants did not need their rescue inhaler ranged from about 81% to 86% across the feedback groups, compared to about 76% in the no-data group. The number of total rescue inhaler doses used between months four and six ranged from approximately 27 to 55 doses across the groups; the data was not reported in a way that allows a simple directional conclusion to be drawn without further context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02555371 · results posted 5 February 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02555371) looked at mepolizumab, an injectable medicine, in people with severe asthma. The study ran across several stages. In the first stage (Parts A and B), 306 people received mepolizumab injections for up to about two and a half years. In the next stage (Part C), 151 people were randomly assigned to receive a placebo (dummy) injection and 144 received mepolizumab, for up to 52 weeks. A final open-label stage (Part D) followed, where participants continued or switched to mepolizumab. The main thing being measured in Part C was how many participants had a significant asthma flare-up — defined as one serious enough to need steroid tablets for at least three days, a hospital admission, or an emergency department visit. The reported data shows that, over the course of Part C, the percentage of participants who experienced at least one significant flare-up grew over time in both groups. By around the 52-week mark, the reported figures were approximately 47% in the mepolizumab group and 61% in the placebo group. For flare-ups serious enough to require a hospital stay or emergency department visit specifically, the reported percentages at the end of Part C were around 8% in the mepolizumab group and 6% in the placebo group. Regarding a type of white blood cell called eosinophils (which are linked to airway inflammation in some people with asthma), the reported data shows that levels in the placebo group were roughly six times their starting level at various time points, while in the mepolizumab group they remained close to starting levels. For a questionnaire measuring asthma symptom control (scored 0–6, where higher means worse control), the reported data shows that by around 52 weeks, approximately 63% of the mepolizumab group and 79% of the placebo group had their score worsen by 0.5 points or more from their starting score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02774941 · results posted 31 January 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 220 children in total — 110 in each group. One group received asthma treatment through a standard jet nebuliser (the control group), while the other group received treatment through a vibrating mesh nebuliser (the study group). The trial was measuring whether the type of nebuliser used made a difference to how often children needed to be admitted to hospital, and how many rounds of treatment were needed before a child's asthma symptoms were mild enough to be sent home. The reported data shows that, of the 109 children who completed the trial in the jet nebuliser group, 22 were hospitalised. In the vibrating mesh nebuliser group, 15 out of 108 children who completed the trial were hospitalised. Regarding the number of treatment rounds needed before children reached the level where they could be discharged, the reported data shows an average of 3 treatments for the jet nebuliser group and 2 treatments for the vibrating mesh nebuliser group. It is worth noting that this trial was conducted in a specific clinical setting and involved a particular group of participants. The reported data shows the numbers as recorded during the trial, but no broader conclusions should be drawn from these figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03478657 · results posted 9 December 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 222 children in total — 88 children aged 5 to 7 years (Stratum 1) and 134 children aged 8 to 11 years (Stratum 2). The trial was measuring whether children in these two age groups could correctly use an inhaler device called the ELLIPTA dry powder inhaler (DPI), and whether they found it easy to use. Children used the inhaler once daily for 28 days with a placebo (an inactive substance with no medicine in it), and were assessed at the start and end of the study period. The reported data shows that, after 28 days of use, 92% of the younger children (aged 5–7) and 93% of the older children (aged 8–11) were able to demonstrate correct use of the inhaler on their first attempt, without any prompting. When both age groups were looked at together, the figure was 93%. Among those who demonstrated correct use at that 28-day visit, 98% in both age groups reported rating the inhaler as easy to use. The reported data also shows results from the very first day of the trial (before any home practice): at that point, 24% of the younger children and 50% of the older children could use the inhaler correctly on their first attempt. On that same first day, 51% of the younger group and 25% of the older group made at least one "critical error" — meaning a mistake in a key step of using the inhaler. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02495168 · results posted 29 November 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,147 people in total — 504 in the generic budesonide/formoterol group, 516 in the brand-name Symbicort group, and 127 in the placebo (inactive inhaler) group. The trial was measuring lung function in people with asthma, comparing a generic version of a combination inhaler to the brand-name product (Symbicort) and to a placebo. The main thing being measured was how well air moved in and out of the lungs — specifically using a breathing test called FEV1 (the amount of air a person can forcefully breathe out in one second) — both shortly after the first dose and after six weeks of treatment. The reported data shows that on the first day of treatment, when lung function was tracked over 12 hours after dosing, the generic inhaler group recorded an average score of approximately 3.637 litre-hours (a combined measure of how much lung function improved and for how long), compared to 3.584 litre-hours for the Symbicort group and 1.460 litre-hours for the placebo group. For the six-week (end of treatment) measure, the reported data shows that lung function before a dose had risen by an average of 0.278 litres above starting levels in the generic group, 0.283 litres in the Symbicort group, and 0.094 litres in the placebo group. These figures were used to assess whether the generic and brand-name inhalers performed similarly to one another, and whether both performed differently from placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03135899 · results posted 27 November 2019

  According to the results reported on ClinicalTrials.gov, this trial looked at an investigational medicine called BI 443651, tested at three different doses (100, 400, and 1,200 micrograms), compared against a placebo (an inactive treatment). The trial was conducted in two parts and involved a total of 38 participants across both parts — 4 in Part 1 and 34 in Part 2. The main thing being measured was how much a breathing test called FEV1 (which measures how much air a person can forcefully breathe out in one second) changed after participants were given a substance called methacholine, which is used in controlled clinical settings to temporarily trigger airway narrowing. The trial was essentially examining how the different doses of BI 443651 influenced this airway response. The reported data shows that in Part 1, the maximum drop in FEV1 after the methacholine challenge, compared to a starting measurement (baseline), was: placebo group +0.018 litres, 100 μg dose +0.390 litres, 400 μg dose −0.195 litres, and 1,200 μg dose +0.272 litres. In Part 2, those figures were: placebo +0.005 litres, 100 μg +0.064 litres, 400 μg −0.032 litres, and 1,200 μg −0.152 litres. The secondary outcomes looked at two additional things: how lung function behaved over a period of time after the challenge (reported as a ratio compared to baseline), and how long it took for breathing to return close to the pre-challenge level. The reported data shows recovery times (in hours) ranging from around 0.32 to 0.78 hours across the different groups and doses in both parts of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02224157 · results posted 25 November 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 2,095 people in one group and 2,094 in another — just over 4,000 participants in total. One group used a Symbicort inhaler only when needed (with a dummy/placebo taken twice daily as a regular dose), while the other group took a regular twice-daily dose of Pulmicort plus a Terbutaline reliever inhaler to use when needed. The trial was primarily measuring how often participants had a severe asthma attack — defined as one serious enough to require steroid tablets for at least three days, a hospital stay, or an emergency department visit needing steroids. The reported data shows that, on average, the "as-needed Symbicort" group had 0.11 severe attacks per person per year, compared with 0.12 in the regular Pulmicort group. Looking at individuals, 177 people in the Symbicort as-needed group and 184 people in the Pulmicort group experienced at least one severe attack. The trial also measured lung function (how much air participants could breathe out in one second, before using any inhaler). The reported average improvement from the starting point was 104 millilitres in the Symbicort as-needed group and 136.6 millilitres in the Pulmicort group. Both groups reduced how often they used their reliever inhaler each day by a similar amount (roughly 0.84–0.87 fewer puffs per day on average). The percentage of days where no reliever inhaler was needed increased by about 41 percentage points in the Symbicort as-needed group and about 48 percentage points in the Pulmicort group. The reported data also shows that zero participants in the Symbicort as-needed group were withdrawn from treatment due to asthma-related safety rules set by the trial, compared with four participants in the Pulmicort group — however, what this difference means clinically was not elaborated on in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00180661 · results posted 4 October 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 39 adults in total — 19 with non-severe asthma and 20 with severe asthma. All 39 participants completed the study with no dropouts. The trial was measuring lung function, and looking at how well a steroid medicine (dexamethasone) was able to dial down the activity of certain immune cells (monocytes and alveolar macrophages) in laboratory tests using participants' own cells. It also looked at the effect of corticosteroids (a type of anti-inflammatory medicine) on the release of signalling molecules called cytokines from those immune cells. The reported data shows that for lung function — measured as how much air a person can forcefully breathe out in one second (called FEV1, expressed as a percentage of what would be expected for a healthy person of the same age and size) — the non-severe asthma group recorded an average of 84.9%, while the severe asthma group recorded an average of 59.9%. For the immune cell suppression measure, the reported data shows that dexamethasone suppressed a particular signalling molecule (IL-8, involved in inflammation) by around 30% in the non-severe asthma group, compared to around 10% in the severe asthma group. For the third primary outcome — the effect of corticosteroids on cytokine release from macrophages — no numerical results were reported in the submitted data. For the three secondary outcomes (exhaled nitric oxide, eosinophils measured from biopsies, and eosinophils measured from sputum — all different ways of looking at airway inflammation), no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02374138 · results posted 23 September 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 217 children — 110 in the "usual care" group and 107 in an "intervention" group. The trial followed participants over six and twelve months, tracking how asthma affected their daily lives. The main thing being measured was the number of "symptom-free days" — days in the past two weeks where a child had no coughing, wheezing, chest tightness, shortness of breath, and no need for a reliever puffer. The trial also looked at night-time symptoms, medication use, emergency department visits, and courses of steroid treatment for flare-ups. The reported data shows that for the primary measure — symptom-free days out of the last 14 — the usual care group averaged 11.4 days and the intervention group averaged 11.6 days. For night-time symptom days (out of 14), the reported figures were 1.7 (usual care) and 1.9 (intervention) at one time point, and 2.1 (usual care) and 1.5 (intervention) at another. The reported data shows that emergency department visits averaged 0.32 per child in both groups at six months, and 0.33 (usual care) versus 0.42 (intervention) at twelve months. For courses of steroid treatment, the numbers reported were 0.30 (usual care) and 0.29 (intervention) at one point, and 0.26 (usual care) and 0.30 (intervention) at another. No numerical data was reported for the asthma severity and control outcome measure. Medication use figures were reported as numbers of participants rather than averages, and the specific time points for those figures were not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02153359 · results posted 12 September 2019

  According to the results reported on ClinicalTrials.gov, 23 people took part in this trial, which looked at whether using an air cleaner in the home made a difference to the level of indoor dust particles and to asthma-related symptoms. It was a "crossover" trial, meaning each participant used both a real air cleaner and a dummy (sham) air cleaner for one month each, with a break of at least a month in between. The trial measured two types of airborne particles — fine particles (called PM2.5, which are very tiny) and coarser particles (called PM2.5-10, which are slightly larger) — as well as several asthma symptom measures recorded in daily diaries. The reported data shows that when participants were using the real air cleaner, the average level of fine particles in their homes was measured at 18.95 micrograms per cubic metre, compared with 32.73 when using the sham device. For coarser particles, the figures were 7.89 with the real air cleaner versus 13.93 with the sham. Regarding symptoms, the reported data shows that participants recorded an average of 4 symptom-free days per month with the real air cleaner and 3.76 with the sham. Days where activities were limited due to asthma averaged 2.48 (real) versus 2.33 (sham). Nights disrupted by asthma symptoms averaged 0.95 (real) versus 1.14 (sham). Days of school or work missed averaged 0.10 (real) versus 0.24 (sham). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02605824 · results posted 20 August 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02605824) was set up to compare two inhaled treatments — a 20% solution of N-acetylcysteine (NAC, a mucus-thinning agent) and a 0.9% saline (salt water) solution — in people with a lung condition. The trial aimed to measure two things: changes in a standard breathing test called FEV1 (which captures how much air a person can forcefully breathe out in one second, taken after using a reliever inhaler), and changes in a CT scan score that counts how many sections of the lungs are affected by mucus. The reported data shows that only one participant was enrolled in the NAC group and no participants were enrolled in the saline group. That single participant did not complete the study. Because of this, no results were recorded or submitted for either the primary outcome (the breathing test) or the secondary outcome (the CT mucus score) — the data for both measures was not reported. Given that the trial enrolled just one participant and collected no outcome data, the reported results do not allow any conclusions to be drawn about how the two treatments compared. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00200850 · results posted 12 June 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people in total — 10 in a low-dose group, 10 in a high-dose group, and 11 in a placebo group (a group that received a dummy treatment with no active ingredient). Not everyone finished the study: 7 people completed it in the low-dose group, 9 in the high-dose group, and 5 in the placebo group. The trial was investigating a treatment placed under the tongue (sublingual) containing house dust mite allergen. It was measuring how much house dust mite allergen participants could inhale before their lung function dropped by a set amount — a test used to assess sensitivity to that allergen. The reported data shows that this sensitivity test was carried out at the start of the study (called "baseline") and again after 12–18 months of treatment. The unit used to measure allergen tolerance was "cumulative breath units" — the higher the number, the more allergen a person could tolerate before their breathing was affected. At baseline, the low-dose group recorded 75.0 units, the high-dose group 69.5 units, and the placebo group 141.4 units. At the 12–18 month point, the reported figures were 74.8 units for the low-dose group, 100.9 units for the high-dose group, and 83.3 units for the placebo group. No additional outcome measures were reported in the submitted data. It is worth noting that the three groups started with noticeably different baseline values, and the trial had a small number of participants, which the reported data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03052725 · results posted 21 March 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT03052725) enrolled 391 people with asthma — 194 who had previously received a placebo in an earlier study and 197 who had previously received the medicine being studied, reslizumab 110 mg. All participants received reslizumab as a subcutaneous injection (a shot under the skin) in this follow-on study. The trial was primarily measuring how many participants experienced unexpected medical events (called adverse events) while on the treatment, and also tracked things like blood test results, injection site reactions, vital signs, and the rate of asthma flare-ups. The reported data shows that, among those who had previously received placebo, 102 out of 194 participants experienced at least one adverse event during the study, compared with 114 out of 196 in the group who had previously received reslizumab. Serious adverse events were reported in 7 participants in the first group and 6 in the second. For injection site reactions, the vast majority in both groups — 191 and 194 participants respectively — had no reaction noted, with only a small number recording any response. Abnormal blood test results (for things like blood cell counts and kidney or liver markers) were recorded in small numbers across both groups. The reported rate of asthma flare-ups was 0.42 episodes per year in the group that previously had placebo, and 0.70 episodes per year in the group that had previously received reslizumab. Around 46–47 participants in each group completed the full study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02452190 · results posted 6 February 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02452190) enrolled 232 people in the placebo group and 236 people in the reslizumab 110 mg group, with 197 and 212 participants respectively completing the full 52-week study. The trial was measuring how often participants had serious asthma flare-ups (called clinical asthma exacerbations — periods where asthma got bad enough to need steroids, a hospital stay, or an emergency department visit) over one year, as well as several other asthma-related measures including lung function, quality of life, symptom scores, and the proportion of well-controlled days. The reported data shows that for the primary outcome — the rate of asthma flare-ups over 52 weeks — the placebo group had an adjusted average of 0.52 flare-up events, while the reslizumab group had an adjusted average of 0.41 events. For lung function (how much air participants could breathe out forcefully in one second), the placebo group improved by an average of 0.225 litres from their starting point, compared with 0.368 litres in the reslizumab group. On the quality-of-life questionnaire (scored 1–7, where higher means better), both groups improved from their starting scores by similar amounts: 1.06 points for placebo and 1.14 points for reslizumab. On the asthma control questionnaire (scored 0–6, where lower means better controlled), both groups also showed similar reductions: minus 1.14 for placebo and minus 1.22 for reslizumab. The reported data also shows that total asthma symptom scores (day and night combined, on a 0–9 scale where lower is better) decreased by 1.4 points in the placebo group and 1.5 points in the reslizumab group. The percentage of days classed as "well-controlled" increased by 7.1 percentage points in the placebo group and 8.0 percentage points in the reslizumab group over the course of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02258542 · results posted 6 February 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02258542) enrolled participants from several related asthma studies (known as SIROCCO, CALIMA, and ZONDA) who received the medicine benralizumab at a dose of 30 mg. Participants were split into groups based on which parent study they came from and how often they received the medicine — either every 4 weeks or every 8 weeks. In total, across all four groups, roughly 2,123 people started the trial, including a smaller sub-group of 86 adolescents from the SIROCCO/CALIMA studies. The trial was measuring changes in certain blood cell counts — specifically basophils (a type of immune cell), leukocytes (white blood cells overall), and lymphocytes (another type of immune cell) — from the start of treatment to the end. The reported data shows small changes in these blood cell counts across all groups. For basophils, the reported average change from starting levels ranged from about −0.005 to −0.007 (measured in billions of cells per litre of blood), with one adolescent sub-group showing a very small increase of +0.001. For leukocytes (overall white blood cells), the reported changes were larger in some groups — ranging from about −0.128 to −0.808 — meaning counts were generally slightly lower at the end of the study than at the start, with the ZONDA every-4-weeks group showing the largest reported decrease. For lymphocytes, the reported changes ranged from −0.180 to +0.007 across the different groups. These are small numerical shifts in blood measurements, and the trial was designed to track these figures rather than to measure symptom outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01370317 · results posted 25 January 2019

  According to the results reported on ClinicalTrials.gov, this trial looked at a drug called MK-1029 and involved 27 people in total — 18 received MK-1029 and 9 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring two things: how many participants experienced any unexpected or unwanted medical events (called adverse events) during the study, and how many people stopped taking the study treatment because of such an event. It also tracked how the drug moved through the body over time, including how much of the drug was in the blood and how quickly it reached its peak level. The reported data shows that 9 out of 18 participants in the MK-1029 group experienced at least one adverse event, compared with 3 out of 9 participants in the placebo group. Importantly, no participants in either group stopped taking their treatment because of an adverse event — that figure was zero in both groups. For the blood-level measurements in the MK-1029 group, the reported data shows that the amount of drug in the blood over a 6-hour period (a measure of overall exposure) was 745 on Day 1 and 505 on Day 28 (measured in ng\*hr/mL). The highest level of the drug recorded in the blood was 295 ng/mL on Day 1 and 167 ng/mL on Day 28. The time it took to reach that peak blood level was 2 hours on Day 1 and 3 hours on Day 28. No placebo group figures were reported for these blood-level measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02766374 · results posted 3 January 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 68 people in total — 35 in a group receiving HRV (heart rate variability) biofeedback and 33 in a group receiving EEG+ biofeedback. Biofeedback is a technique where people are given real-time information about their body's signals to help them learn to influence certain physical responses. Of those who started, 25 people in the HRV group and 30 in the EEG+ group completed the trial. The trial was measuring changes in airway reactivity — essentially, how sensitive or reactive the airways are — using a test called methacholine PC20FEV1. This test measures how much of a substance (methacholine) is needed to cause a notable change in breathing capacity, and a higher number generally means less reactive airways. The reported data shows that, after the biofeedback sessions, the average change in airway reactivity scores was 2.98 mg/ml in the HRV biofeedback group and 2.12 mg/ml in the EEG+ biofeedback group. These figures represent the magnitude of change from each participant's starting measurement to their measurement after the biofeedback period. It is worth noting that the group labels in the outcome data are listed as "HRV-BF" and "PBO-BF" (where PBO may refer to a placebo-style comparison condition), which does not perfectly match the group names described elsewhere in the record — the data as submitted does not fully clarify this discrepancy. No other outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02253433 · results posted 14 November 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02253433) involved 264 adults with asthma — 130 in a group receiving enhanced clinic care, and 134 in a group receiving enhanced clinic care plus a home-based intervention. By the end of the study, 114 people in the first group and 79 in the second group had completed the trial. The trial was measuring changes in asthma control (using a standard 5-question survey called the Asthma Control Test, or ACT), changes in asthma-related quality of life (using a 15-question survey called the MiniAQLQ), and changes in the number of emergency department or urgent care visits related to asthma. The reported data shows that both groups started with similar ACT scores — around 12.5 out of 25 for each group — which, based on the scale described, would suggest poor asthma control at the start. By the end of the study, the reported scores had risen to 16.2 for the enhanced clinic care group and 16.8 for the enhanced clinic care plus home intervention group. For the quality-of-life questionnaire (scored from 1 to 7, where higher is better), both groups started at around 3.2–3.3, and by the end the reported scores were 4.3 and 4.5 respectively. Regarding emergency visits in the 12 months before and after the study, the enhanced clinic care group reported an average of 2.2 visits at the start and 1.3 at the end, while the combined group reported 2.6 visits at the start and 1.1 at the end. It is worth noting that the numbers above describe what was measured and recorded — they do not indicate why those numbers changed or whether the change was due to any particular part of the program. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02414854 · results posted 23 October 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,902 adults across four groups to study dupilumab, a medicine given by injection every two weeks, in people with moderate-to-severe asthma. Participants were randomly assigned to receive either dupilumab (at one of two doses — 200 mg or 300 mg) or a placebo (inactive injection) every two weeks for 52 weeks. The trial was measuring two main things: how often participants had severe asthma flare-ups (episodes serious enough to need steroid tablets or a hospital/emergency visit) over the year, and how much their lung function — specifically the amount of air they could forcefully breathe out in one second (called FEV1) — changed after 12 weeks of treatment. The reported data shows that for severe flare-ups, the placebo groups had rates of approximately 0.87 and 0.97 flare-ups per person per year, while the dupilumab groups had rates of approximately 0.46 and 0.52 flare-ups per person per year respectively. For lung function at 12 weeks, the placebo groups showed an average improvement of about 0.15–0.18 litres from their starting point (roughly a 10–12% increase), while the dupilumab groups showed an average improvement of about 0.28–0.31 litres (roughly a 19–21% increase). In a subgroup of participants who had higher levels of a particular immune cell (eosinophils) in their blood at the start of the trial, the reported flare-up rates followed a similar pattern. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01385306 · results posted 10 October 2018

  According to the results reported on ClinicalTrials.gov, this trial involved 6 people who were treated with a device called the AlphaCore System, which delivers non-invasive nerve stimulation (gentle electrical signals applied to the skin without needles or surgery). All 6 participants completed the trial. The study was measuring things like unwanted side effects, changes in breathing ability, changes in how breathless participants felt, how long they stayed in the emergency department, and whether they needed other medications. The reported data shows that 2 out of 6 participants experienced adverse events (unwanted effects) during or after the procedure, with follow-up checks at 7 days and a phone call at 30 days. For breathing ability — measured using a standard lung test called FEV1, which checks how much air a person can forcefully breathe out in one second — 4 out of 6 participants showed an improvement of 12% or more compared to their starting level, measured 30 minutes after the second stimulation. For breathlessness, the reported data shows an average score of 6.75 out of 10 before treatment and 3.10 out of 10 afterwards (where 0 means no breathlessness and 10 means very severe breathlessness). The reported average time to leave the emergency department after the stimulation was 193 minutes. Regarding other medications, the data shows 5 participants received medications before the stimulation and 6 received medications after — though further detail on this was not reported. It is worth noting that with only 6 participants, this was a very small study, and the reported figures reflect a very limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02501629 · results posted 13 September 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02501629) enrolled 177 adults — 89 in a placebo group and 88 receiving a fixed dose of reslizumab (110 mg). The trial was looking at whether reslizumab could reduce the amount of daily steroid tablets (oral corticosteroids, or OCS) that people with asthma needed to take, while still keeping their asthma under control. Participants who did not finish the study numbered 5 in the placebo group and 7 in the reslizumab group. The reported data shows that for the main question the trial was trying to answer — how much participants' daily steroid tablet dose changed over weeks 20 to 24 — results were spread across five categories ranging from "no decrease" to large reductions. In the placebo group, 48 out of 89 participants showed no decrease, compared with 42 out of 88 in the reslizumab group. Smaller numbers in each group showed reductions of varying sizes. For the secondary measures, 44% of the reslizumab group and 36% of the placebo group were reported to have cut their steroid tablet dose by at least half while keeping asthma under control. The reported data also shows that 42% of the reslizumab group and 38% of the placebo group reached a daily steroid tablet dose of 5 mg or less while maintaining asthma control. Using a statistical modelling approach, the average percentage reduction in daily steroid tablet dose was reported as approximately 58% for the reslizumab group and approximately 40% for the placebo group. The reported rate of asthma flare-ups per year was 1.51 for the reslizumab group and 1.86 for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02567708 · results posted 1 August 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people in total — 24 were assigned to receive a placebo first and then the study drug (GSK2269557), while 26 received the study drug first and then the placebo. The trial used a "crossover" design, meaning everyone received both the real drug and the placebo at different times, with a washout break in between. The main thing being measured was a lung function test called FEV1 — how much air a person can forcefully breathe out in one second — specifically looking at whether that number changed after 28 days of treatment. The reported data shows that, for the primary measure, participants taking the placebo showed an average increase of 0.027 litres in their FEV1 from their starting point, while those taking GSK2269557 showed an average increase of 0.035 litres. In a slightly stricter analysis (looking only at participants who closely followed the trial rules), the placebo group showed an increase of 0.029 litres and the GSK2269557 group showed an increase of 0.042 litres. The reported data shows that for secondary measures — including lung function readings taken at Day 7 and Day 14, the average FEV1 measured over four hours after dosing on Day 28 (2.672 litres for placebo versus 2.722 litres for GSK2269557), and measures of total air exhaled — the numbers across both groups were broadly similar and in some cases moved in different directions at different time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02066129 · results posted 11 July 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 254 children with asthma — 127 in each of two groups. One group used a lower-dose fluticasone inhaler (44 micrograms) and the other used a higher-dose fluticasone inhaler (220 micrograms) during periods when their asthma symptoms worsened (called "yellow zone" episodes). The trial ran for 48 weeks and was primarily measuring how often children had serious asthma flare-ups that needed steroid tablets to treat them. The reported data shows that for the main outcome — serious asthma flare-ups requiring steroid tablets — the lower-dose group had a reported rate of 0.37 flare-ups per year, while the higher-dose group had a reported rate of 0.48 flare-ups per year. For the secondary outcomes, symptom scores during yellow-zone episodes (rated on a scale of 0 to 252, where higher means more symptoms) were reported as 20 for the lower-dose group and 23 for the higher-dose group. The number of puffs of reliever (rescue) medication used during yellow-zone episodes was reported as 13 puffs for the lower-dose group and 15 puffs for the higher-dose group. Unscheduled emergency department or urgent care visits were reported at a rate of 0.47 per year in the lower-dose group and 0.64 per year in the higher-dose group. The reported data also shows that no participants in the lower-dose group were hospitalised for asthma during the study period, compared with 4 participants in the higher-dose group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03099096 · results posted 29 June 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 159 adults who used a mepolizumab liquid autoinjector — a self-injection device — over an eight-week period. The trial was measuring how often participants (or their caregiver) were able to successfully inject themselves with the device on their own. Because different countries have different labelling rules, two versions of the device label were tested: one that included a pictogram (a small instructional picture) alongside standard text, and one with standard text only. Of the 159 people who started, 157 completed the study and 2 did not finish. The reported data shows that the main thing being measured was whether participants could successfully self-administer their third dose at Week 8, watched by clinic staff. For those using the label with a pictogram, 99% of participants recorded a successful injection at that visit. For those using the standard label only, 98% recorded a successful injection. The trial also measured how people went with an unsupervised injection done at home at Week 4. The reported data shows that 98% of the pictogram-label group and 96% of the standard-label-only group recorded a successful self-injection at home. It is worth noting that this trial had only one group — everyone used the mepolizumab autoinjector — so there was no comparison group receiving a different treatment or a dummy injection. The results simply describe how often the injection was recorded as successful under each labelling condition. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01691859 · results posted 22 May 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 347 people, all of whom received a 100 mg dose of mepolizumab given by injection. The trial was an open-label study, meaning everyone received the same treatment with no comparison group. It was primarily designed to track and count unwanted medical events (called adverse events) and serious unwanted medical events that occurred while participants were on the treatment. The trial also looked at heart rhythm measurements (using an ECG, a test that records the electrical activity of the heart) and some blood test results. The reported data shows that out of 347 participants who received at least one dose, 326 experienced at least one adverse event (an unwanted medical occurrence during the treatment period), and 79 experienced at least one serious adverse event during that same window. Regarding injection-site or allergic-type reactions specifically, the reported data shows 9 participants experienced a systemic reaction (such as an allergic-type response) and 42 experienced a local reaction at the injection site. For the heart rhythm measurements, small changes from starting values were reported across multiple time points — the figures ranged from around −0.5 to 5.1 milliseconds depending on the time point and calculation method used — and the reported data shows these were generally small in magnitude. A small number of participants showed notable blood test results of potential concern, with figures of 1, 1, and 7 participants flagged across different blood chemistry measures. The data notes that zero participants formally completed the study as defined by the trial's completion criteria, though the reason for this is not explained in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02135692 · results posted 2 May 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 339 adults who received mepolizumab 100 mg by injection under the skin (subcutaneously). The trial was an open-label study, meaning all participants received the same treatment with no comparison group. It was measuring how often participants had serious asthma flare-ups (called exacerbations) while on treatment, as well as tracking asthma control scores, a breathing test called FEV1 (which measures how much air a person can forcefully breathe out in one second), and recording any unwanted medical events (adverse events) that occurred during the study period. The reported data shows that the average rate of asthma flare-ups during treatment was 0.93 per person per year — meaning, on average, participants experienced just under one significant flare-up per year. For the asthma control questionnaire (scored from 0, meaning fully controlled, to 6, meaning severely uncontrolled), the reported data shows small changes from participants' starting scores across different time points during the study, ranging from around −0.21 to +0.34 on the scale. For the breathing test (FEV1), the reported changes from participants' starting measurements across different time points ranged from approximately 14 millilitres to 78 millilitres. Regarding unwanted medical events, the reported data shows that 315 out of 339 participants experienced at least one adverse event during treatment, and 84 participants experienced a serious adverse event. Additionally, 78 participants were hospitalised due to adverse events including asthma flare-ups, 2 participants withdrew from the study due to lack of effect, and 3 withdrew due to adverse events. It is worth noting that the data shows zero participants were recorded as having "completed" the study, with all 339 listed as "not completed" — this likely reflects how the study's milestones were structured or reported, rather than meaning everyone dropped out, but the specific reason for this recording was not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01581710 · results posted 12 April 2018

  According to the results reported on ClinicalTrials.gov, this trial involved 32 children in total — 18 in one group and 14 in the other. It used a "crossover" design, meaning each child took both montelukast (a medication commonly used for asthma and allergies) and a placebo (a dummy treatment with no active ingredient) at different times, with a two-week break in between. The trial was measuring lung function using two types of breathing tests: one called IOS (which measures how easily air flows in and out of the airways using sound waves) and one called spirometry (which measures how much and how fast air can be breathed out). All 32 children completed the first treatment period and the washout break; two children in the "Placebo to Montelukast" group did not complete the final stage. The reported data shows lung function readings taken at three points: before any treatment (baseline), after two weeks on placebo, and after two weeks on montelukast. For the IOS measurements, the airway resistance reading at baseline was 0.73 kPa/L/s, after placebo it was 0.74 kPa/L/s, and after montelukast it was 0.73 kPa/L/s. A related airway measurement (reactance at 5Hz) was −0.34 at baseline, −0.36 after placebo, and −0.34 after montelukast. For the spirometry test measuring how much air could be forcefully breathed out in one second (FEV1), the reported figures were 1.28 litres at baseline, 1.25 litres after placebo, and 1.28 litres after montelukast. The ratio of that breath to total lung capacity was 83.55% at baseline, 83.04% after placebo, and 85.93% after montelukast. The remaining IOS readings showed similarly small differences across the three time points. The reported numbers reflect what was measured and recorded in this trial for this specific group of children under these specific conditions. No conclusions about whether the medication performed better or worse than placebo should be drawn from this summary alone, as interpreting those differences requires clinical expertise. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01290874 · results posted 30 March 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT01290874) enrolled 532 people in the tiotropium group and 538 people in the salmeterol-or-formoterol group — a total of 1,070 participants. The trial ran over 12 months and was designed to compare these two types of inhaled medicines in people with asthma, looking mainly at how often asthma flare-ups (exacerbations) occurred, and also at lung function, asthma control, quality of life, and symptom scores. It is worth noting that relatively few participants completed the full study period — 122 in the tiotropium group and 134 in the comparison group — though the reasons for this were not detailed in the data provided here. The reported data shows that, for the primary measure — the rate of asthma flare-ups — the tiotropium group had an average of 0.37 flare-ups per person per year, while the salmeterol-or-formoterol group had an average of 0.42 flare-ups per person per year. For lung function (measured by a breathing test called FEV1, which records how much air a person can breathe out in one second), the tiotropium group showed an average change of −0.018 litres over 12 months, and the comparison group showed an average change of +0.003 litres — meaning both groups' readings stayed close to where they started. On the Asthma Control Questionnaire (a 0–6 scale where lower scores mean better control), both groups' scores fell by a similar amount: −0.70 for tiotropium and −0.66 for the comparison group. On the quality-of-life questionnaire (scored 1–7, where higher means better), both groups improved by almost the same amount: 1.00 and 1.02 respectively. The symptom score (rated 0–1, where 1 means no symptoms) rose by 0.11 in the tiotropium group and 0.10 in the comparison group. The data for the symptom-free days questionnaire was not reported in the results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02615743 · results posted 31 January 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02615743) involved 41 children with asthma and their caregivers — 21 in the intervention group (who received daily text message reminders about medication) and 20 in a control group (who did not receive reminders at first). The trial was measuring two main things: whether it was practical for families to keep using an electronic device that tracks inhaler use over 30 days (called "feasibility"), and whether families found the text message reminders acceptable or helpful. The reported data shows that, of those who started the study, 15 out of 21 in the intervention group and 17 out of 20 in the control group completed the 30 days of monitoring. On the question of acceptability — specifically, how many participants found the text message reminders helpful for avoiding missed doses — 15 out of 15 completing participants in the intervention group responded positively, compared with 5 out of 17 in the control group (noting that control group participants were only offered text messages after their first 30 days). For the secondary outcomes, the reported average medication adherence (the percentage of prescribed doses actually taken, as recorded by the electronic device) was 34% for the intervention group and 40% for the control group. Asthma control was also measured using a standard questionnaire scored from 5 (poor control) to 25 (complete control); the reported average change in score from the start to the end of the study was an increase of 1.0 points in the intervention group and 3.1 points in the control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02040779 · results posted 11 December 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 273 participants across three groups: 91 received a placebo inhaler (breath-actuated inhaler, or BAI), 90 received a lower dose of the inhaled corticosteroid beclomethasone dipropionate (BDP) at 80 micrograms via BAI, and 92 received a higher dose of BDP at 160 micrograms via BAI. The trial ran for 12 weeks and was measuring lung function and asthma-related outcomes in people with asthma. Not everyone who started the trial completed it — 79, 83, and 88 participants finished in each group respectively. The reported data shows that the main outcome measured was a lung function test called FEV1 (how much air a person can breathe out forcefully in one second), tracked over the 12-week period. The reported average adjusted scores for this measure were 0.048 litres for the placebo group, 0.171 litres for the lower-dose BDP group, and 0.164 litres for the higher-dose BDP group. For the secondary outcomes, morning and evening peak airflow (how fast air moves out of the lungs) showed reported changes from starting levels of approximately −0.8, +12.8, and +7.1 litres per minute (morning) and −0.8, +10.1, and +4.6 litres per minute (evening) for the placebo, lower-dose, and higher-dose groups respectively. The reported data also shows small changes in the daily use of rescue inhaler puffs (−0.01, −0.37, and −0.40 puffs per day) and in asthma symptom scores (−0.17, −0.29, and −0.30 points on a 0–9 scale) across the three groups. For the outcome measuring time until a participant had to stop treatment due to worsening asthma, no numerical result was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00162773 · results posted 28 August 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 29 participants, all placed in a single group. The trial was measuring changes in free serum IgE levels — that is, the amount of a particular immune-system protein (IgE) circulating in the blood — from the start of the study to later time points. Of the 29 people who began the trial, only 7 completed it, while 22 did not finish. The reported data shows that although the primary outcome measure — changes in free serum IgE levels from the start of the study — was listed, no actual numerical results were submitted or recorded against it in the ClinicalTrials.gov data. This means the specific figures for this measurement were not reported in the structured results available, so it is not possible to describe what the numbers showed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01218399 · results posted 18 August 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01218399) involved 10 people in total — 5 in a group taking Symbicort (a combination inhaler) and 5 in a group taking Budesonide (a single-ingredient inhaler). All 10 participants completed the study, with no one dropping out. The trial was measuring lung function in people with asthma, using a standard breathing test called FEV1 — which stands for Forced Expiratory Volume in one second. In plain terms, this test measures how much air a person can forcefully breathe out in one second, expressed as a percentage, where higher numbers generally indicate better lung function. The reported data shows that the Symbicort group recorded an average FEV1 of 90%, while the Budesonide group recorded an average FEV1 of 88%. According to the trial's own description, a score over 90% is considered in the mild asthma range, 80–90% in the moderate range, and below 80% in the severe range — meaning both groups fell within or on the border of the moderate-to-mild range based on those benchmarks. For the secondary outcome, the reported data shows that zero adverse events (unwanted or unexpected health occurrences) were recorded in either group, though it is worth noting this was a very small study of only 5 people per group, which limits how much can be drawn from these numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02260492 · results posted 15 June 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 879 people across three groups: 418 received a treatment called OT329 Solis, 419 received Advair Diskus (an existing inhaler containing fluticasone and salmeterol), and 42 received a placebo (an inactive treatment with no medicine). The trial was measuring lung function — specifically a breathing test called FEV1, which measures how much air a person can forcefully breathe out in one second — to compare whether OT329 Solis and Advair Diskus produced similar results. By the end of the study, 395 people in the OT329 Solis group, 406 in the Advair Diskus group, and 37 in the placebo group had completed the trial. The reported data shows two main (primary) measurements of lung function. The first looked at how lung function changed over 12 hours after the first dose, measured as a combined score across multiple time points (called an "area under the curve," meaning the total breathing performance tallied up over that period). The reported figures were 29.610 litres for OT329 Solis, 30.151 litres for Advair Diskus, and 27.270 litres for placebo. The second primary measurement looked at lung function after four weeks of treatment — the reported average FEV1 readings were 2.516 litres for OT329 Solis, 2.579 litres for Advair Diskus, and 2.323 litres for placebo. As a secondary (additional) measure, the trial recorded how many participants experienced adverse events (unwanted health occurrences during the study): 67 out of 418 in the OT329 Solis group, 66 out of 419 in the Advair Diskus group, and 7 out of 42 in the placebo group. No further detail about the nature of those events was included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01576718 · results posted 12 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 889 people with asthma into an initial run-in period, of whom 640 went on to the main treatment phase. In the treatment phase, around 106–107 participants were assigned to each of six groups: four different doses of a new inhaled medicine called Fp MDPI (50, 100, 200, or 400 micrograms), a placebo (dummy inhaler with no active medicine), or an already-approved inhaler called Flovent Diskus 250 mcg. The trial ran for 12 weeks and was primarily measuring changes in lung function, specifically a breathing test called FEV1 — which captures how much air a person can forcefully breathe out in one second. The reported data shows that for the main outcome — the change in FEV1 from the start of treatment to the end of the 12 weeks — participants in the placebo group showed an average increase of 0.053 litres. The four Fp MDPI dose groups showed average increases of 0.059 litres (50 mcg), 0.101 litres (100 mcg), 0.109 litres (200 mcg), and 0.125 litres (400 mcg). Results for the Flovent Diskus group were not reported for this outcome. For the secondary outcomes, the reported data shows that morning and evening peak flow measurements (how fast air can be breathed out, measured in litres per minute) also changed from baseline across all groups. Morning peak flow changes ranged from about 2.2 litres/minute in the placebo group to around 9–10 litres/minute across the Fp MDPI dose groups; evening peak flow changes ranged from about 3.4 litres/minute (placebo) to about 11 litres/minute (400 mcg dose). The reported probability of remaining in the study at week 12 without worsening asthma was 0.47 for the placebo group, and ranged from 0.59 to 0.69 across the Fp MDPI dose groups, with 0.57 reported for the Flovent Diskus group. Changes in the percentage of days without needing rescue medication, and blood-level measurements of the medicine, were also reported across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01772368 · results posted 12 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 72 participants in total, with 65 completing the study and 7 not completing it. The trial tested several different inhaler treatments for asthma, comparing four different dose combinations of a two-medicine inhaler (called FS MDPI, containing fluticasone propionate and salmeterol) against a single-medicine inhaler (Fp MDPI, containing fluticasone propionate alone) and an existing combination inhaler called Advair Diskus. The main thing being measured was how much a standard lung function test — called FEV1, which measures how much air a person can forcefully breathe out in one second — changed over the 12 hours after taking each treatment. The reported data shows that, for the primary measurement (the average change in lung function across the 12 hours after the dose), the single-medicine inhaler group recorded a value of around 52 mL above their starting level. The four combination-inhaler groups recorded higher values: approximately 204 mL, 249 mL, 280 mL, and 303 mL above their starting level, corresponding to increasing doses of the second medicine (salmeterol). The existing Advair Diskus comparison group recorded approximately 246 mL above their starting level. A similar pattern was reported for the secondary lung function measure at exactly 12 hours after the dose, ranging from about 12 mL (single-medicine inhaler) up to about 238 mL (highest combination dose), with the Advair Diskus group at about 171 mL. Blood level measurements of salmeterol were also reported and rose with increasing doses of the combination inhaler. The number of participants who experienced adverse events (unexpected medical occurrences during the study) ranged from 1 to 3 across the different treatment groups during the double-blind phase, with 17 participants experiencing adverse events during a separate run-in period; no serious adverse events were reported for most groups, with one noted in one group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01479621 · results posted 12 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 909 people with asthma into an initial run-in phase, of whom 622 moved on to the main 12-week treatment period. During the treatment period, participants were divided into six groups of around 103–104 people each: four groups received different doses of a fluticasone propionate inhaler delivered via a new dry-powder device called an MDPI (at 12.5, 25, 50, or 100 micrograms), one group received a placebo (dummy) inhaler via the same device, and one group received an already-approved fluticasone inhaler called Flovent Diskus at 100 micrograms. The trial was primarily measuring changes in a breathing test called FEV1 — how much air a person can forcefully breathe out in one second — taken in the morning before any medication. Several other measures were also tracked, including morning and evening peak airflow (how fast air can be blown out), how often participants needed their rescue inhaler, and how likely people were to remain in the study for the full 12 weeks. The reported data shows that, for the primary breathing test (FEV1), all groups showed an increase from their starting level over the 12 weeks. The placebo group's average increase was reported as 0.118 litres, while the four active-dose groups showed increases of 0.170, 0.229, 0.243, and 0.267 litres respectively (from lowest to highest dose); the Flovent Diskus group's result was not reported in the submitted data for this measure. For morning peak airflow, the placebo group's average change from baseline was reported as 9.26 litres per minute, compared with changes of approximately 21 to 31 litres per minute across the four active-dose groups and about 30 litres per minute for the Flovent Diskus group. Evening peak airflow showed a similar pattern, with the placebo group reporting a change of 9.42 litres per minute and the active groups ranging from about 18 to 28 litres per minute. For rescue-inhaler-free days, the reported change from baseline ranged from about 21% for the placebo group up to about 34% for the 12.5 mcg group, with all active groups reporting higher percentages than placebo. The estimated probability of remaining in the study at 12 weeks was 0.57 for the placebo group, compared with values between 0.77 and 0.91 across the active-dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01921894 · results posted 23 March 2017

  According to the results reported on ClinicalTrials.gov, this trial involved 24 children in total — 8 in each of three groups. Each group took a different daily dose of vitamin D (called cholecalciferol): a high dose of 4,000 IU, a medium dose of 2,000 IU, or a low dose of 200 IU. The trial was measuring how many children in each group reached a blood vitamin D level considered "sufficient" (30 ng/ml or above) after 4 weeks and again after 8 weeks of taking the supplement. All 24 children who started the trial completed it. The reported data shows that after 4 weeks, 6 out of 8 children in the 4,000 IU group, 7 out of 8 in the 2,000 IU group, and 4 out of 8 in the 200 IU group had reached the target vitamin D level. After 8 weeks, all 8 children in the 4,000 IU group, 6 out of 8 in the 2,000 IU group, and 4 out of 8 in the 200 IU group had reached that level. The trial also tracked several other measures — including signs of vitamin D toxicity, an elevated calcium-to-creatinine ratio in urine (a marker checked via a simple urine test), and a lung function reading — and reported zero participants across all three groups showed a concerning result for any of these measures. It is worth noting that with only 8 children per group, this was a very small trial, and the reported figures reflect a limited number of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01845025 · results posted 21 March 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01845025) enrolled 820 people with asthma — 411 in a group receiving a combination of formoterol (FOM 12 mcg) plus fluticasone propionate (FP), and 409 receiving fluticasone propionate (FP) alone. The trial ran for 26 weeks and was primarily measuring serious asthma-related events (hospitalisation, the need for a breathing tube, or death), as well as a range of other day-to-day outcomes such as asthma flare-ups, days missed from school or work, nights woken by asthma, days with limited normal activity, and days when no reliever ("rescue") inhaler was needed. By the end of the study, 326 people in the combination group and 332 in the FP-alone group had completed the trial. The reported data shows that for the primary outcome — serious asthma-related events — both groups recorded 3 occurrences each over the 26 weeks, with no asthma-related deaths or intubations reported in either group. For the secondary outcomes, the average number of asthma flare-ups was reported as 1.3 events in the combination group and 1.2 in the FP-alone group. The percentage of school or work days missed was reported as approximately 0.97% for the combination group and 0.56% for the FP-alone group. Days where participants had limited ability to carry out normal daily activities were nearly identical — about 4.73% for the combination group and 4.75% for the FP-alone group. Nights disturbed by asthma symptoms were reported at around 4.55% of days for the combination group and 4.20% for the FP-alone group. Finally, the percentage of days on which no reliever inhaler was needed was reported as approximately 76.97% for the combination group and 73.29% for the FP-alone group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01606306 · results posted 16 March 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 300 children across six groups (ranging from 47 to 52 per group). It was a crossover-style study, meaning each child tried three different asthma treatments one after another, in different orders depending on which group they were in. The trial was looking at whether individual children responded differently to the three treatments — specifically by tracking two things: how long it took before a child needed oral steroids (a strong medicine) for a worsening of their asthma, and how many "asthma control days" they had (days with no symptoms, no need for rescue medication, and no unplanned visits to a doctor). Of the 300 who started, 226 completed all three treatment periods. The reported data shows that, among children who completed at least two treatment periods and kept regular diary records, the study measured the likelihood (expressed as a probability, meaning a number between 0 and 1, where 1 = certainty) that a child would respond better to one treatment than another. Four probability figures were reported for the group of all evaluable participants: 0.26, 0.40, 0.18, and 0.16. The data submitted to ClinicalTrials.gov does not include labels explaining exactly what each of these four figures individually refers to, so a more detailed breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02446613 · results posted 15 March 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT02446613) enrolled 16 people in total — 6 received a placebo nasal spray once a week, and 10 received a nasal spray called GSK2245035 (at a dose of 20 nanograms) once a week. All 16 participants completed the trial with none dropping out. The trial was measuring nasal allergy symptoms after participants underwent a controlled nasal allergen challenge (NAC) — a procedure where allergens are deliberately introduced into the nose to trigger a measurable response. Symptoms were tracked using a Total Nasal Symptom Score (TNSS), which combines ratings for congestion, runny nose, nasal itch, and sneezing on a scale where higher numbers indicate more severe symptoms. The trial also measured Peak Nasal Inspiratory Flow (PNIF), which is a measure of how easily air can be breathed in through the nose, with a higher percentage change meaning a bigger drop from the person's starting airflow. The reported data shows that, for the primary symptom score (TNSS), the GSK2245035 group had a reported median change from baseline of 5.9 points at 15 minutes after the allergen challenge, compared with 3.8 points in the placebo group. Over the first hour, the reported figures were 3.4 (GSK2245035) versus 2.4 (placebo), and over six hours, 1.6 versus 1.2. The maximum recorded change over the six-hour period was reported as 5.9 for the GSK2245035 group and 4.1 for the placebo group. For the airflow measure (PNIF), the reported percentage drop from baseline at 15 minutes was 32.2% for GSK2245035 and 27.6% for placebo, and over the first hour, 25.0% versus 20.8%. No secondary outcome data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01716754 · results posted 8 March 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01716754) enrolled 471 adults with asthma across four groups: 199 received a high dose of an investigational medicine called QGE031, 40 received a low dose of QGE031, 135 received an existing asthma medicine called omalizumab, and 97 received a placebo (an inactive treatment). The trial was mainly measuring how many participants in the high-dose QGE031 group showed a meaningful improvement in asthma symptom control, using a questionnaire called the ACQ-7, where lower scores mean better-controlled asthma. The reported data shows that for the primary measure — the proportion of people whose ACQ-7 score improved by at least a certain amount — 63.2% of those on high-dose QGE031 met that threshold, compared with 70.2% in the placebo group and 69.2% in the omalizumab group. For the secondary measures, the reported data shows that average ACQ-7 scores fell (meaning asthma symptom scores went down) across all groups over the course of the study, with changes ranging roughly from -0.5 to -0.9 points depending on the group and time point. Around 40% of the high-dose QGE031 group, 34% of the placebo group, and 37% of the omalizumab group showed a larger improvement of more than 1.1 points on that same scale. Quality-of-life scores and use of rescue puffer medication were also measured as secondary outcomes, and the reported data shows modest changes across all groups, with figures not notably different between the treatment and placebo groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01156792 · results posted 3 February 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 162 participants, of whom 93 completed the study and 69 did not finish. Because this was a crossover-style trial, all participants were grouped together rather than split into separate arms from the start. The trial was testing an investigational drug called GSK2190915 (at two different doses) added to an inhaled steroid called fluticasone propionate (FP), and comparing this combination against FP alone with a placebo, FP combined with an approved add-on medicine called montelukast, and FP combined with salmeterol (an established combination therapy). The main thing being measured was lung function — specifically how much air participants could forcefully breathe out in one second (called FEV1), recorded before their morning dose and before any rescue inhaler use, at the end of a six-week treatment period. The reported data shows that at the end of the six-week period, average FEV1 readings across the five treatment groups were fairly similar. The FP-plus-placebo group recorded an average of 2.36 litres, the FP-plus-GSK2190915 100 mg group recorded 2.39 litres, the FP-plus-GSK2190915 300 mg group recorded 2.40 litres, the FP-plus-montelukast group recorded 2.42 litres, and the FP/salmeterol group recorded 2.43 litres. For the secondary measures — including morning and evening peak flow (how fast participants could breathe out, measured in litres per minute), daily asthma symptom scores (rated on a scale from 0 to 5, with lower meaning fewer symptoms), and daily use of rescue inhalers — the reported values were also close across all groups. For example, morning peak flow ranged from about 349 to 361 litres per minute, evening peak flow from about 354 to 364 litres per minute, average symptom scores from about 2.15 to 2.26, and average daily rescue inhaler puffs from about 2.03 to 2.17 across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00640016 · results posted 31 January 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT00640016) enrolled 14 people in total across four groups: 3 received a placebo (a dummy treatment with no active ingredient), 3 received a low dose of CAT-354 (1 mg/kg), 4 received a medium dose (5 mg/kg), and 4 received a high dose (10 mg/kg). For the analysis, the groups were combined into two categories: a "sub-therapeutic" group (placebo plus the low dose) and a "therapeutic" group (the medium and high doses combined). The trial was measuring how participants' airways responded to a substance called methacholine — a test used to assess airway sensitivity — as well as breathing measurements and a questionnaire about asthma symptoms. It is worth noting that only 4 of the 14 participants who started the trial completed it, with 10 not completing it across all groups. The reported data shows that the primary outcome — the change in airway sensitivity to methacholine at Day 28 — was recorded as −0.604 (in log2 units) for the therapeutic-dose group and −1.545 for the sub-therapeutic group. These numbers represent a change from the starting point, with a more negative number indicating a shift in airway sensitivity in one direction. For the secondary breathing measurements (how much air participants could forcibly exhale in one second, and the total volume of air exhaled), the reported data shows figures ranging across time points in both groups, with no clearly consistent pattern reported in the data. The asthma symptom questionnaire scores (on a scale of 0 meaning well controlled to 6 meaning extremely poorly controlled) were reported across several time points, with the therapeutic-dose group's scores ranging from about 1.43 to 2.44, and the sub-therapeutic group's scores ranging from about 0.57 to 2.36. It is important to note that this was a very small trial with only 14 participants enrolled, and the reported data should be understood in that context. The trial results do not include certain statistical details that would normally help interpret what the numbers mean, and those details were not reported in the data provided to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗

• NCT01444430 · results posted 15 December 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 11,693 people with asthma — 5,846 assigned to Symbicort (a combination inhaler containing budesonide and formoterol) and 5,847 assigned to budesonide alone (a single-ingredient inhaler). The trial was primarily measuring two things: how many participants experienced a serious asthma-related event (specifically death, being placed on a breathing machine, or being hospitalised due to asthma), and how many experienced an asthma flare-up serious enough to need steroid tablets or an emergency visit. The reported data shows that for the serious composite endpoint, 43 participants in the Symbicort group and 40 in the budesonide group experienced one of those events. For asthma flare-ups, 539 participants in the Symbicort group and 633 in the budesonide group had a qualifying event. On the secondary measures, participants in the Symbicort group reported having no asthma symptoms on about 81.1% of days, compared with 76.8% for the budesonide group. Days with activity limitations due to asthma were reported as 19.7% for the Symbicort group and 19.1% for the budesonide group. Average use of rescue inhaler puffs per day was 0.8 for Symbicort and 0.9 for budesonide. On the asthma control questionnaire (scored 0–6, where lower scores indicate better control), both groups improved from their starting scores — the Symbicort group's average score dropped by 0.70 points and the budesonide group's by 0.62 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02322788 · results posted 7 November 2016

  According to the results reported on ClinicalTrials.gov, this trial involved 60 people in total, split across four groups who received different versions or doses of two treatments — referred to as M2 and M3 — at either a lower dose (0.5 mg) or a higher dose (1.5 mg). The trial used a crossover design, meaning participants moved between groups across multiple visits, with all 60 completing each stage they were assigned to. The main thing being measured was how the airways responded to a substance called methacholine — specifically, the concentration of methacholine needed to cause a 20% drop in a breathing measurement called FEV1 (how much air a person can forcibly breathe out in one second). A higher number here means the airways were less reactive, because more of the substance was needed to trigger that drop. The reported data shows the following results for this primary measure, expressed in mg/mL: the M2 group at the higher dose (1.5 mg) recorded a value of 20.10 mg/mL, and the M2 group at the lower dose (0.5 mg) recorded 10.78 mg/mL. For M3, the higher dose (1.5 mg) recorded 17.70 mg/mL, and the lower dose (0.5 mg) recorded 9.88 mg/mL. No secondary outcome measure data was included in the submitted results. Any outcome measures beyond the primary one were not reported in the data available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00552448 · results posted 14 September 2016

  According to the results reported on ClinicalTrials.gov, this trial looked at children admitted to hospital with a severe asthma attack (called "status asthmaticus"). It compared two groups: children who used a device called a High Frequency Chest Compression (HFCC) machine — which delivers rapid, gentle vibrations to the chest — and children who did not use the device. A total of 20 children were enrolled in the HFCC group and 16 in the non-HFCC group, with 19 and 16 respectively completing the study. The main thing being measured was how many hours each child spent in the Paediatric Intensive Care Unit (ICU). The reported data shows that children in the HFCC group spent an average of 23.71 hours in the Paediatric ICU, while children in the non-HFCC group spent an average of 23.76 hours. For one of the secondary measures — an asthma severity score (rated on a scale of 0 to 18, where a higher number means more severe symptoms) — the HFCC group recorded an average score of 1.88 and the non-HFCC group recorded 1.90. Regarding chest discomfort, 3 participants in the HFCC group and 0 in the non-HFCC group were reported to have experienced it. The total days of hospital admission was listed as a secondary outcome, but the reported data shows this information was not collected and no figures were provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01479595 · results posted 1 August 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 65 people with asthma — 44 received the investigational treatment called QBX258, and 21 received a placebo (an inactive comparison). The trial was mainly measuring changes in asthma control using a standard questionnaire called the Asthma Control Questionnaire (ACQ), where a score of 0 means fully controlled and 6 means severely uncontrolled. A lower score after treatment means the participant's reported asthma control had improved. The reported data shows that, on average, participants in the QBX258 group had their ACQ score go down by 0.513 points from where they started, while participants in the placebo group had virtually no change (a shift of just 0.001 points). For the secondary measures, the QBX258 group showed a small increase in the amount of air they could forcefully breathe out in one second (FEV1) of 0.076 litres, compared with 0.050 litres in the placebo group. On the asthma quality-of-life questionnaire (scored 1–7, where higher is better), the QBX258 group's average score rose by 0.580 points and the placebo group's by 0.468 points. A measure of maximum airflow speed also increased slightly more in the QBX258 group (0.099 L/sec) than in the placebo group (0.025 L/sec). The reported data for morning and evening peak flow readings was not reported in the submitted results. Separately, 2 participants in each group were found to have developed antibodies against components of QBX258, which was one of the things the trial was monitoring. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02164539 · results posted 28 June 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled participants across several treatment groups testing different inhaled combinations of three medicines — fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI) — at varying doses. The trial ran in up to three phases, with the main four-week phase (Phase A) including around 338 participants spread across six treatment arms. A smaller group of participants also took part in shorter one-week phases (Phase B and C). The trial's main focus was on measuring lung function using a breathing test called FEV1 — essentially how much air a person can forcefully breathe out in one second — to see how it changed over the course of treatment. The reported data shows that in the main four-week phase, all groups saw some increase from their starting FEV1 measurement. The group taking FF alone (the comparison group) had a reported change of +0.047 litres, while the combination groups ranged from +0.143 to +0.193 litres, with the FF/UMEC 100/62.5 µg group showing the highest reported figure. For the secondary measures, rescue inhaler use (puffs taken for symptom relief) changed by +0.6 puffs per day in the FF-alone group, while most combination groups showed smaller increases or slight decreases, ranging from -0.5 to 0.0 puffs. Respiratory symptom scores (on a scale of 0–40, where higher means worse symptoms) changed by +0.5 in the FF-alone group, compared to reported changes ranging from -2.6 to -1.1 in the combination groups. Morning peak flow (a separate breathing speed measure) changed by -14.2 litres per minute in the FF-alone group, while combination groups ranged from +3.9 to +10.5 litres per minute. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01287039 · results posted 27 June 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 489 adults with asthma — 244 received a placebo and 245 received a medicine called reslizumab (given as an intravenous drip at a dose of 3.0 mg/kg). Of those who started, 215 in the placebo group and 218 in the reslizumab group completed the full 12 months. The trial was primarily measuring how often participants experienced serious flare-ups of their asthma (called clinical asthma exacerbations) over 52 weeks, and also looked at several other measures such as lung function, asthma control, and quality of life. The reported data shows that, on average, participants in the placebo group had an adjusted rate of about 1.80 flare-ups over the 52-week period, compared with about 0.90 flare-ups in the reslizumab group. For lung function — measured by how much air a person can forcefully breathe out in one second — the placebo group showed an average improvement of 0.11 litres from their starting point, while the reslizumab group showed an average improvement of 0.25 litres. On a quality-of-life questionnaire (scored 1 to 7, where higher is better), both groups improved from their starting scores, with the placebo group rising by 0.70 points and the reslizumab group by 0.93 points. On an asthma control questionnaire (where a lower score means better control), the placebo group's score dropped by 0.68 points and the reslizumab group's dropped by 0.94 points. On a symptom score (0 to 1, higher is better), the placebo group improved by 0.109 and the reslizumab group by 0.167. For the time to a first flare-up, the reported median for the placebo group was approximately 34.9 weeks; the corresponding figure for the reslizumab group was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01290887 · results posted 6 June 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01290887) enrolled 1,052 participants in total — 481 who had previously received a placebo in an earlier related study, and 571 who had previously received the drug reslizumab. All participants received reslizumab in this follow-on study. The trial was primarily measuring how many people experienced adverse events (unwanted medical occurrences) and abnormal laboratory test results during treatment. It also tracked several measures of lung function over time. The reported data shows that, when looking at any adverse event during treatment, 359 of the 480 participants in the previous-placebo group and 385 of the 571 in the previous-reslizumab group had at least one such event. Serious adverse events were reported in 49 participants from the previous-placebo group and 41 from the previous-reslizumab group. Regarding abnormal lab values that were considered potentially clinically significant, 13 participants in the previous-placebo group and 10 in the previous-reslizumab group had such findings recorded. For the lung function measurements (secondary outcomes), the reported data shows average breathing capacity figures — for example, the volume of air exhaled in one second (FEV1) was around 2.15–2.28 litres across the groups at various time points, remaining broadly similar across the measurement periods reported. Other lung function measures followed a comparable pattern of relatively stable figures across time points for both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02570425 · results posted 30 May 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 516 participants in total (274 in one group and 242 in the other). The trial compared two different types of asthma inhalers — the Spiromax and the Turbohaler — to see how well people could learn and then remember the correct technique for using each device. Participants went through a structured training programme and were then checked by an expert assessor at different points in time, including four and eight weeks after their training. The reported data shows that for the main outcome — how many people were still using their inhaler correctly four weeks after training — 40% of participants demonstrated correct technique with the Turbohaler, compared with 64% with the Spiromax. For the secondary outcomes, which looked at how quickly people picked up correct technique during the training programme itself, the reported figures also differed between the two devices. After just the first level of training (out of six levels), 4% of Turbohaler users and 22% of Spiromax users were recorded as having mastered their device; after the second level, those figures were 31% and 58% respectively. At the four-week check, using a minimal amount of training prompts, 40% of Turbohaler users and 64% of Spiromax users demonstrated mastery; with more training steps allowed, those figures rose to 77% and 86%. At eight weeks, the reported data shows 65% for the Turbohaler and 79% for the Spiromax after a minimal level of training prompts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01329939 · results posted 7 April 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 26 participants in total across four groups: overweight or obese children and teenagers with allergic asthma, and normal-weight children and teenagers with allergic asthma. Each weight group was split between those who received montelukast (a tablet commonly used for asthma and allergies) and those who received a placebo (a dummy treatment with no active ingredient). The trial ran for 24 weeks and was measuring asthma control, lung function, certain substances in the blood and urine linked to inflammation, and the amount of inhaled steroid medication being used. Not everyone who started the trial finished it — 16 of the 26 participants completed the study. The reported data shows that after 24 weeks, asthma control scores (measured on a questionnaire where higher numbers mean better control) were recorded as follows: overweight/obese participants on montelukast scored 25.00, normal-weight participants on montelukast scored 24.00, normal-weight participants on placebo scored 20.5, and overweight/obese participants on placebo scored 15.75. For lung function (measured as a percentage of what would be expected for a person of similar age and size), the reported data shows a range of roughly 72% to 102% across the groups depending on which specific breathing test was used. A substance in the blood called leptin — which is linked to body fat — was reported at much higher levels in the overweight/obese groups (around 34–44 ng/mL) compared with the normal-weight groups (around 4–11 ng/mL). A urine marker of airway inflammation (LTE4) was reported as highest in the overweight/obese placebo group (313 pg/mL) and lower in the other three groups (172–198 pg/mL). A breath test for airway inflammation also showed the highest reading in the overweight/obese placebo group (39.5 ppb). The daily inhaled steroid dose was reported as highest in the overweight/obese placebo group (1,210 micrograms) and lowest in the normal-weight montelukast group (580 micrograms). It is worth noting that only 16 people completed this trial, which is a very small number, and the reported results reflect only those who finished. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01842607 · results posted 3 March 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 651 adults who were already receiving mepolizumab (given as an injection under the skin at a dose of 100 mg) as part of earlier studies. The trial was an open-label study — meaning everyone received the same treatment with no comparison group — and it was designed to track what happened to participants over a longer period, including any unwanted medical events and changes in asthma-related measurements. By the end of the study, 585 participants had completed it, while 66 did not. The reported data shows that out of 651 participants, 558 experienced at least one unwanted medical event (called an adverse event) during the treatment period. Of those, 119 were described as serious adverse events, and 94 were considered possibly related to the study medicine. One participant experienced a serious local reaction at the injection site, and no participants experienced a serious allergic-type reaction. Regarding the body's immune response to the medicine, 31 out of 615 participants tested positive for antibodies against the medicine; none of those 31 tested positive for a stronger type of antibody (called neutralising antibodies) that can sometimes reduce how a medicine works in the body. The reported data also shows that participants had an average of 0.93 asthma flare-ups per year during the study. Scores on the Asthma Control Questionnaire — a 0-to-6 scale where lower means better-controlled asthma — showed small changes from the starting point at various time points, ranging from around −0.05 to +0.20. A breathing measurement (the amount of air a person can forcefully breathe out in one second) showed reported increases from the starting point of 29 to 67 millilitres at different time points during the study. Nineteen participants left the study due to unwanted medical events, and 11 left due to what was recorded as lack of expected benefit. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01514760 · results posted 18 February 2016

  According to the results reported on ClinicalTrials.gov, this trial involved 22 participants who were all assigned to use a mobile phone-based Asthma Action Plan (AAP) — a digital tool designed to help people record their asthma symptoms and peak flow readings (a simple breath test that measures how well air moves out of the lungs). Twenty of the 22 participants completed the study, while two did not finish. The trial was measuring how often participants used the app, whether they used it during acute (sudden or worsening) symptoms, and how scores on two questionnaires — one about asthma self-confidence and one about asthma control — compared before and after the intervention. The reported data shows that, on average, participants used the mobile Asthma Action Plan roughly 4.3 days per week to record their routine symptoms or peak flow measurements. For use during acute symptoms, the reported data shows that 11 out of the 22 participants used the Asthma Action Plan at least once when they were experiencing sudden symptoms. Regarding the self-confidence questionnaire (scored from 14 to 70, where higher means more confident in managing asthma), scores of 57.2 and 62.8 were reported — though the data as submitted does not clearly label which figure is the before measurement and which is the after measurement. Similarly, for the asthma control questionnaire (scored 5 to 25, where higher means better control, and 19 or below may suggest asthma is not well controlled), four scores were reported — 20.3, 19.4, 15.3, and 19.1 — however, the submitted data does not clearly indicate which scores correspond to which time points or subgroups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01899144 · results posted 8 February 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 61 children and measured how two inhaler devices — Albuterol Spiromax (a dry-powder inhaler) and ProAir HFA (a standard metered-dose inhaler) — affected breathing compared with a placebo (an inactive treatment). Each participant went through up to five treatment periods, trying different doses or devices. The trial tracked lung function using a measure called FEV1, which is the amount of air a person can forcefully breathe out in one second, expressed as a percentage of what would be expected for a child of similar age, height, and sex. The reported data shows that the main outcome — a score combining lung-function readings taken over six hours after a dose — was higher for all active treatments than for placebo. Specifically, the reported scores (in units that capture both the size and duration of the lung-function change) were: Albuterol Spiromax 90 mcg: 46.6; Albuterol Spiromax 180 mcg: 48.0; ProAir HFA 90 mcg: 37.9; ProAir HFA 180 mcg: 49.1; and placebo: 25.4. A secondary measure looking at raw air volume over the same six-hour window showed similar patterns, with values of 0.88, 0.93, 0.74, 0.93, and 0.48 litres×hour respectively. Regarding unwanted medical events that occurred during the study, the reported data shows that across all active treatment periods combined, small numbers of participants experienced such events (0, 2, 5, and 1 participants across the four active treatment groups, and 1 in the placebo group); no serious adverse events were reported in any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01000506 · results posted 5 February 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01000506) enrolled 616 adults with severe asthma across four groups: one group received a placebo (a dummy treatment with no active ingredient) given by drip into a vein, and three groups received different doses of a medicine called mepolizumab (75 mg, 250 mg, or 750 mg), also given by drip. The trial ran for 52 weeks and was primarily measuring how often participants had serious asthma flare-ups — meaning episodes bad enough to need steroid tablets, a hospital admission, or an emergency department visit. Most participants completed the study: between 127 and 133 out of each group of roughly 152–156 people finished the full 52 weeks. The reported data shows that the placebo group had an average of 2.40 serious flare-ups per year. The three mepolizumab groups had reported rates of 1.24 (75 mg), 1.46 (250 mg), and 1.15 (750 mg) flare-ups per year. For flare-ups serious enough to require hospitalisation or an emergency department visit specifically, the placebo group's reported rate was 0.43 per year, compared with 0.17, 0.25, and 0.22 per year for the three mepolizumab doses respectively. The reported data also shows that by the end of 52 weeks, around 70% of placebo participants had experienced at least one serious flare-up, compared with approximately 49%, 58%, and 50% in the three mepolizumab dose groups. As a secondary measure, the trial also tracked how quickly participants had their first serious flare-up. The reported data shows that by week 16, roughly 45% of placebo participants had already had a flare-up, compared with around 23%, 27%, and 19% across the three mepolizumab groups. These proportions continued to rise across all four groups through to week 52, as noted above. All figures are as submitted by the trial sponsor and reflect the overall group averages — individual results varied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00999466 · results posted 26 January 2016

  According to the results reported on ClinicalTrials.gov, this trial tested an inhaled investigational medicine called AZD8848 in people with asthma. The trial ran in two parts. In the pilot part, 6 people received the lower dose (30 μg) and 3 received a placebo (an inactive treatment), and all of them completed it. In the main part, 26 people received the higher dose (60 μg) and 25 received a placebo; of those, 22 and 21 respectively completed the study. The trial's main focus was on measuring how much airflow participants could push out of their lungs in one second (known as FEV1) after they were exposed to an allergen — specifically looking at a "late response" that occurs several hours after that exposure. The reported data shows the main (primary) outcome was expressed as a ratio comparing lung airflow during the hours after allergen exposure to the person's own baseline reading before the challenge — a lower number means a bigger drop in airflow. Before any treatment was given, the reported ratios for the late response were 0.814 (30 μg group) and 1.01 (placebo group). One week after the last dose, the reported ratios were 0.616 (60 μg group) and 0.970 (placebo group). Four weeks after the last dose, the reported ratios were 0.759 (60 μg group) and 0.722 (placebo group). Note that pre-treatment data was only reported for the 30 μg group, while the one-week and four-week follow-up data was only reported for the 60 μg group — the remaining figures were not reported in the submitted data. For the secondary outcome — an "early response" measured in the first two hours after allergen exposure — the reported ratios across the three time points (before treatment, one week after, and four weeks after the last dose) were 0.524, 0.468, and 0.510 for the 60 μg group, and 0.611, 0.624, and 0.591 for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01691508 · results posted 26 January 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01691508) enrolled 135 people with severe asthma who were dependent on daily steroid tablets (called oral corticosteroids, or OCS) to control their condition — 66 in the placebo group and 69 in the mepolizumab 100 mg injection group. The trial was measuring whether participants could reduce their daily steroid tablet dose over a five- to six-month period while still keeping their asthma under control (meaning no serious flare-ups requiring extra steroids or a hospital visit). The reported data shows that, looking at the primary outcome — how much each person's steroid tablet dose changed between weeks 20 and 24 — the results across the two groups were as follows. In the mepolizumab group: 16 people achieved a 90–100% reduction, 12 achieved a 75–under 90% reduction, 9 achieved a 50–under 75% reduction, and 7 achieved a small reduction of more than 0 but under 50%; 25 people had no decrease, lost asthma control, or left the study early. In the placebo group the corresponding numbers were 7, 5, 10, 7, and 37. For the secondary outcomes, the reported data shows that 37 people in the mepolizumab group versus 22 in the placebo group achieved at least a 50% reduction in their steroid tablet dose; 37 versus 21 reduced their dose to 5 mg or less per day; and 10 versus 5 stopped taking steroid tablets altogether during that period. The reported median percentage change in daily steroid dose was a 50% reduction in the mepolizumab group compared with no change (0%) in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01691521 · results posted 26 January 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 576 adults across three groups: 191 received a placebo (dummy treatment), 191 received mepolizumab given into a vein (75 mg IV), and 194 received mepolizumab given by injection under the skin (100 mg SC). The trial ran for 32 weeks and was primarily measuring how often participants had serious asthma flare-ups — defined as episodes bad enough to need steroid medicines, a hospital stay, or an emergency department visit. The reported data shows that for the main outcome, the placebo group had a reported rate of 1.74 serious flare-ups per year, compared to 0.93 per year in the IV mepolizumab group and 0.83 per year in the under-the-skin mepolizumab group. For flare-ups that led to a hospital stay or emergency department visit, the reported rates were 0.20 (placebo), 0.14 (IV), and 0.08 (under-the-skin) per year. For flare-ups requiring hospitalisation alone, the reported figures were 0.10, 0.06, and 0.03 per year respectively. The reported data also shows that lung function (measured as the amount of air expelled in one second) changed from the starting point by an average of 86 millilitres in the placebo group, 186 mL in the IV group, and 183 mL in the under-the-skin group. Finally, a quality-of-life questionnaire (scored 0–100, where higher scores mean greater impact on daily life) showed average score changes of −9.0 (placebo), −15.4 (IV), and −16.0 (under-the-skin) from the start of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00588406 · results posted 21 January 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 95 people in total — 46 in the budesonide group and 49 in the placebo group (a placebo is a dummy treatment with no active ingredient). All 95 participants completed the study, with none dropping out. The trial was measuring lung function — specifically a test called FEV1, which looks at how much air a person can breathe out forcefully in one second — as well as how many participants ended up being hospitalised during the study. The reported data shows that, for the main measurement (FEV1 as a percentage of what would be expected for a healthy person of similar age and size), the budesonide group scored an average of 51.7% predicted, while the placebo group scored 52.6% predicted. For the secondary measurement — hospitalisation — the reported data shows that 39% of participants in the budesonide group and 39% of participants in the placebo group were hospitalised, meaning the proportion was the same in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01634152 · results posted 21 December 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 401 adults across three groups to compare two doses of a inhaled medicine called tiotropium delivered via a device called Respimat — a lower dose (2.5 micrograms, referred to here as Tio R2.5) and a higher dose (5 micrograms, Tio R5) — against a placebo (an inactive treatment delivered the same way). The trial ran for 12 weeks and focused on measuring lung function, specifically how much air participants could forcefully breathe out. Of the 401 people who started, 392 completed the trial. The reported data shows the main thing being measured was the peak improvement in a standard lung function test — called FEV1 (the amount of air a person can forcefully breathe out in one second) — in the three hours after taking the study treatment at week 12, compared to where each participant started. The placebo group showed an average increase of 0.252 litres, the Tio R2.5 group showed 0.287 litres, and the Tio R5 group showed 0.391 litres. For a separate measure of lung capacity (FVC — the total amount of air that can be breathed out), the peak changes at three hours were 0.244 litres for placebo, 0.201 litres for Tio R2.5, and 0.275 litres for Tio R5. The reported data also shows measurements taken just before the next dose at week 12 (called "trough" readings), with FEV1 changes of 0.136 litres for placebo, 0.154 litres for Tio R2.5, and 0.223 litres for Tio R5. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01698320 · results posted 19 August 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 364 people in an initial run-in period, of whom 337 moved into the main study. Participants were then split into two groups for a 12-week double-blind phase (meaning neither the participants nor the researchers knew who was getting which treatment): 169 people received a placebo inhaler first and then switched to the active albuterol inhaler (delivered via a device called an MDPI), while 168 people used the active albuterol inhaler throughout. After the 12-week phase, both groups used the active albuterol inhaler for a further 40 weeks. The trial's primary focus was on tracking adverse events — that is, any unwanted medical occurrences that happened or got worse during the study — as well as heart tracing (ECG) results. The reported data shows that during the first 12 weeks, 105 out of 169 participants in the placebo-first group and 84 out of 168 in the albuterol-first group experienced at least one adverse event. Serious adverse events (defined as those involving hospitalisation, being life-threatening, causing lasting disability, or requiring urgent medical intervention) were reported for 1 person in the placebo-first group and 5 people in the albuterol-first group during this period. For the longer 40-week open-label phase, the reported data shows 106 and 94 participants in each group respectively experienced adverse events, with 2 and 1 serious adverse events reported. Regarding heart tracings (ECGs), at the 12-week point, 151 participants in the placebo-first group and 154 in the albuterol-first group had normal results, with 19 and 14 respectively showing abnormal but not clinically concerning results, and none recorded as abnormal in a clinically significant way. Similar patterns were reported at week 52. Some other planned measurements — including device reliability data and daily breathing flow readings — were listed in the trial record but no numerical results were reported for those outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00625989 · results posted 15 May 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 12 participants in total, split into two groups of six. It used a "crossover" design, meaning each group received both treatments but in a different order — one group received a harmless salt-water solution (diluent) first and then an allergen challenge, while the other group received the allergen challenge first and then the salt-water solution. The trial was measuring two specific types of immune cells — called myeloid dendritic cells and plasmacytoid dendritic cells — found in mucus coughed up from the lungs (sputum), before and after exposure to an allergen. All 12 participants completed the study. The reported data shows that, when comparing the salt-water (diluent) condition to the allergen challenge condition, both types of immune cells appeared in different quantities in the sputum samples. For myeloid dendritic cells, the reported figure was approximately 32,800 cells per gram of sputum in the diluent condition, compared with approximately 89,100 cells per gram in the allergen condition. For plasmacytoid dendritic cells, the reported figure was approximately 16,000 cells per gram in the diluent condition, compared with approximately 39,900 cells per gram in the allergen condition. These are the numbers as submitted; the trial did not report what, if any, statistical analysis was applied to these figures. The trial also planned to measure levels of certain chemical messengers (chemokines) released in the sputum as secondary outcomes, however no numerical results for those measures were included in the data reported to ClinicalTrials.gov, so those findings cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01225549 · results posted 2 April 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01225549) enrolled 20 participants in total. It was a crossover study, meaning each person received all four treatments at different times — two different doses of an investigational inhaled medicine called AZD5423 (75 micrograms and 300 micrograms), a comparator inhaled steroid called budesonide (2 × 200 micrograms), and a placebo (inactive treatment) — with washout periods in between. The trial was measuring how participants' lungs responded after being exposed to an allergen (a substance known to trigger their symptoms), by tracking a breathing measurement called FEV1 (the amount of air a person can forcefully breathe out in one second), expressed as a percentage of their starting level. The reported data shows that for the primary outcome — the lowest FEV1 reading recorded between 3 and 7 hours after the allergen challenge (known as the "late allergic response") — the figures were: 90.97% for the 75 mcg AZD5423 group, 91.32% for the 300 mcg AZD5423 group, 87.28% for the budesonide group, and 85.83% for the placebo group. For the "early allergic response" (lowest FEV1 in the first 3 hours after allergen exposure), the reported figures were broadly similar across all groups: 69.75%, 69.57%, 67.98%, and 69.30% respectively. Airway sensitivity was also tested using a methacholine challenge (a substance used to assess how reactive the airways are) at three different time points; the reported values across groups ranged from approximately 1.2 to 2.7 mg/mL depending on the time point and treatment arm. One participant did not complete the full trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01603277 · results posted 2 February 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 160 people in total — 78 who received a medicine called an Anti-GM-CSF Monoclonal Antibody (KB003) at a dose of 400mg, and 82 who received a normal saline (salt water) injection, which acted as a dummy treatment for comparison. By the end of the study, 64 people in each group had completed it. The trial was primarily looking at changes in a breathing test result called FEV1 — this measures how much air a person can forcefully breathe out in one second, expressed as a percentage of what would be expected for someone of their age and size. The measurement was taken at 24 weeks. The reported data shows that, on average, the FEV1 percentage figure rose by about 3.6 percentage points in the KB003 group over 24 weeks, compared to a rise of about 2.0 percentage points in the saline group. The trial also set out to measure things like the rate of asthma flare-ups, a separate breathing test called peak expiratory flow, and information about side effects and safety — however, the reported data for all of these secondary outcomes was not provided in the results submitted to ClinicalTrials.gov, so no numbers for those measures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00599872 · results posted 14 January 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 430 people in total — 216 in the active treatment group and 214 in the placebo (dummy treatment) group. The trial was measuring allergy symptoms in people with ragweed allergies during the ragweed pollen season. Participants rated eight symptoms twice a day — including itchy, watery, or swollen eyes; sneezing; itchy, runny, or stuffy nose; and itchy ears — each on a scale of 0 (not present) to 3 (severe), giving a possible daily total of 0 to 48, where a lower number meant fewer symptoms. By the end of the study, 167 people in the active group and 181 in the placebo group had completed the trial. The reported data shows that for the main (primary) outcome — average daily symptom score across the whole ragweed season — the active group scored 6.2 and the placebo group scored 6.5, out of a possible 48. For secondary outcomes, during the single worst pollen week, the active group averaged 7.0 and the placebo group averaged 7.5. When symptoms were broken down by body area, the reported eye symptom scores were 1.7 (active) versus 1.9 (placebo), nasal scores were 4.0 versus 4.2, and ear scores were 0.5 versus 0.5, all out of a maximum of 24. Morning and evening symptom scores were also reported separately, both coming in at 3.5 for the active group and 3.8 and 3.6 respectively for the placebo group. The reported data also shows results for rescue medication use — that is, extra allergy medicines participants took to manage their symptoms. The total medication score across the season was 40.5 for the active group and 50.1 for the placebo group, where a lower score indicated less rescue medication was used. The combined average of daily symptoms plus daily medication use was reported as 6.7 for the active group and 7.3 for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01696357 · results posted 10 December 2014

  According to the results reported on ClinicalTrials.gov, this trial involved 84 adolescents in total — 42 who had asthma and 42 who did not have asthma. The trial was measuring how often adolescents cough, using a device that automatically detected and counted coughs over a 24-hour period. Most participants finished the study: 40 out of 42 in the asthma group and 41 out of 42 in the non-asthma group completed it. The reported data shows that the main outcome being tracked was the average number of coughs per hour. According to the results reported on ClinicalTrials.gov, adolescents in the asthma group recorded an average of approximately 57.64 coughs per hour, while adolescents in the non-asthma group recorded an average of approximately 0.63 coughs per hour. These were the only outcome measure results included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01756391 · results posted 8 December 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01756391) enrolled 351 people in a single observational group — meaning researchers watched and recorded what happened rather than testing a new treatment against a comparison group. Of those who started, 319 people completed the study, while 32 did not finish. The trial was set up to track a range of asthma-related experiences over time, including things like days of slowed-down activity, exercise-triggered symptoms, coughing unrelated to a cold, nights woken by asthma symptoms, hospital admissions, and emergency department visits. The reported data shows that, unfortunately, no actual numerical results were submitted to ClinicalTrials.gov for any of the outcome measures listed — neither the primary findings nor any of the secondary ones (such as hospitalisations or nights woken by symptoms). While the categories being measured are described in the record, the measurements themselves were not reported, so it is not possible to describe what the numbers showed for any of these outcomes. Because the results data was not reported, there is nothing further that can be summarised about what the study found. If you are interested in this research, you may wish to search for any published journal articles linked to this trial, or speak with a healthcare professional who may be aware of findings shared through other channels. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01210170 · results posted 19 November 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 22 people in total, with 15 completing the study and 7 not finishing. The trial was measuring how a steroid inhaler called mometasone, given at different doses and at different times before or alongside a reliever medication called albuterol (also known as a bronchodilator), affected two things in the lungs: a breathing measure called FEV1 (roughly, how much air a person can forcefully breathe out in one second) and something called Qaw (a measure of airflow in the airways). Each participant received different combinations of treatments across the study, so the results are reported for each combination rather than for separate groups of people. The reported data shows the following for the primary outcome — the change in FEV1 after albuterol was inhaled. When 400 mcg of mometasone was given 30 minutes before albuterol, the reported change in FEV1 was 0.27 litres; when a placebo (inactive treatment) was given 30 minutes before, it was 0.18 litres. When 400 mcg mometasone was given at the same time as albuterol, the reported change was 0.32 litres; with placebo at the same time, it was 0.20 litres. When 200 mcg mometasone was given 30 minutes before, the reported change was 0.23 litres. For several other combinations — including the 60-minutes-before conditions and the 200 mcg simultaneous condition — the data was not reported. For the secondary outcome — the percentage change in Qaw after albuterol — the reported data shows: 400 mcg mometasone given 30 minutes before albuterol was associated with an 18% change; placebo 30 minutes before showed 0%; 400 mcg mometasone given simultaneously showed 30%; and placebo given simultaneously showed -2%. For the remaining combinations, the data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01808339 · results posted 4 September 2014

  According to the results reported on ClinicalTrials.gov, this was a small crossover trial — meaning the same participants tried each of the different treatment arrangements in turn, with rest ("washout") periods in between. A total of 28 people were enrolled across six groups that each received the study treatments in a different order. The trial was comparing a inhaled medicine called fluticasone furoate (FF) taken either in the morning or the evening against a dummy treatment (placebo), and was primarily measuring how well participants' lungs were working over a 24-hour period after 14 days of each treatment. Lung function was measured using a test called FEV1 — this simply measures how much air a person can forcefully breathe out in one second. The reported data shows that for the main (primary) outcome — average lung function measured over 24 hours at day 14 — the FF morning dose group recorded an average FEV1 of 3.303 litres, the FF evening dose group recorded 3.332 litres, and the placebo group recorded 3.227 litres. For a secondary measure looking at lung function at specific low points in the day (called "trough" readings), the reported figures ranged from approximately 3.18 to 3.36 litres across the three groups, depending on whether the reading was taken in the morning or evening. The reported data also shows that 18 out of the participants in each of the two FF groups, and 16 in the placebo group, experienced at least one unexpected medical event during the study period. Another secondary measure — peak expiratory flow (a different lung function test) — was monitored during the study but, according to the reported data, was not formally analysed and the numbers were not submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01431950 · results posted 3 September 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 238 people with asthma, split into two groups of 119 each. One group received a once-daily inhaled corticosteroid called fluticasone furoate (FF) at a dose of 100 micrograms, and the other received FF at 200 micrograms. The trial ran for 24 weeks and was mainly measuring changes in lung function, specifically how much air participants could forcefully breathe out in one second (known as FEV1), as well as a number of secondary measures including breathing speed, use of rescue medication, and symptom-free days. The reported data shows that, for the primary measure of lung function (evening FEV1), participants in the 100 µg group had an average increase of 0.208 litres from their starting point, while those in the 200 µg group had an average increase of 0.284 litres. For the secondary measures, the reported data shows the percentage of days without needing rescue medication increased by an average of 21.3 percentage points in the 100 µg group and 23.1 percentage points in the 200 µg group. The percentage of symptom-free days increased by an average of 17.5 percentage points and 19.6 percentage points respectively. Evening peak breathing speed (a measure of how fast air can be exhaled) increased on average by 5.9 litres per minute in the 100 µg group and 7.2 litres per minute in the 200 µg group, while morning peak breathing speed increased by 13.4 and 13.2 litres per minute respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01436071 · results posted 3 September 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 124 participants in each of two groups — one group received a placebo (an inactive treatment) and the other received a once-daily inhaled corticosteroid called fluticasone furoate (FF) at a dose of 50 micrograms. The trial ran for 12 weeks and was mainly measuring changes in lung function, specifically a breathing test called FEV1 (the amount of air a person can forcefully breathe out in one second), taken in the evening before any medication. It also tracked a number of other things, including how often participants needed to use their reliever (rescue) inhaler, how well they could breathe out forcefully (peak expiratory flow, or PEF) in the mornings and evenings, how many days they were free of asthma symptoms, and how many people left the trial early because their asthma was not well controlled. The reported data shows that, for the main lung function measurement, the placebo group's FEV1 increased by an average of 0.038 litres from the start of the trial to week 12, while the FF group's FEV1 increased by an average of 0.157 litres over the same period. For the secondary measures, the reported data shows the percentage of days without needing a rescue inhaler increased by 17.1 percentage points in the placebo group and 28.7 percentage points in the FF group. Evening peak flow (a separate measure of how fast air moves out of the lungs) increased by an average of 19.5 litres per minute in the placebo group and 22.8 litres per minute in the FF group. Morning peak flow increased by 22.9 litres per minute in the placebo group and 34.5 litres per minute in the FF group. The percentage of symptom-free days increased by 14.0 percentage points in the placebo group and 22.6 percentage points in the FF group. Finally, 15 participants in the placebo group and 7 participants in the FF group withdrew from the trial early due to a lack of adequate asthma control. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01136382 · results posted 21 July 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 152 participants in a placebo group and 152 participants in a budesonide (an inhaled corticosteroid) group — 304 people in total. The trial was measuring changes in breathing ability in people with asthma, comparing those who received budesonide against those who received a placebo (an inactive treatment). The main thing being measured was "morning peak expiratory flow" — essentially how fast a person can forcefully breathe out in the morning, recorded in litres per minute. The reported data shows that, for the primary measure, morning peak expiratory flow changed by an average of 4.1 litres per minute in the placebo group and 17.8 litres per minute in the budesonide group, from the starting point to the average across the treatment period. For the secondary measures, the reported data shows small changes in other breathing tests: a measure of air exhaled in the first second (FEV1) changed by 0.00 litres in the placebo group and 0.06 litres in the budesonide group; evening peak flow changed by 4.0 and 14.7 litres per minute respectively; total lung air volume (FVC) changed by 0.00 and 0.04 litres; and a mid-breath airflow measure changed by 0.01 and 0.11 litres per second. Asthma symptom scores (rated 0–3, where lower means fewer symptoms) changed by −0.2 (placebo) and −0.4 (budesonide) for total daily symptoms, and −0.5 (placebo) and −0.8 (budesonide) for daytime symptoms. It is also worth noting that more participants did not complete the trial in the placebo group (60 people) than in the budesonide group (31 people), which may affect how the results are interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00760838 · results posted 26 June 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT00760838) enrolled 109 adults with asthma — 54 in the placebo group and 55 in the azithromycin (an antibiotic) group. The main thing the trial was measuring was how many participants experienced a severe asthma flare-up, defined as an episode serious enough to need antibiotics or cortisone (a steroid medicine) for at least three days. The trial also tracked several secondary measures, including how often participants needed to use "rescue" medication (quick-relief medicine taken when symptoms worsen), breathing test results, and scores on questionnaires about asthma control and quality of life. The reported data shows that for the primary measure — severe asthma flare-ups — the proportion of participants who experienced one was 0.52 (roughly 52 in 100) in the placebo group and 0.55 (roughly 55 in 100) in the azithromycin group. For rescue medication use, the reported proportion was 0.24 in the placebo group and 0.08 in the azithromycin group. For breathing measurements (peak expiratory flow, which is how fast air can be breathed out), small changes from baseline were reported in both groups, with the placebo group showing slightly larger declines. The asthma control questionnaire score (where lower is better, on a 0–6 scale) changed by −0.12 in the placebo group and −0.24 in the azithromycin group. The quality-of-life questionnaire score (where higher is better, on a 1–7 scale) changed by +0.20 in the placebo group and +0.32 in the azithromycin group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01013753 · results posted 5 June 2014

  According to the results reported on ClinicalTrials.gov, 198 people took part in this trial overall. Because it was a crossover design, participants each tried more than one treatment across separate periods — meaning the numbers assigned to each treatment (ranging from 121 to 130 people) overlap rather than representing separate groups. The trial was testing different doses of a once-daily inhaled medicine called olodaterol (Olo, at 2, 5, 10, and 20 micrograms) compared with a placebo (inactive treatment) and an existing twice-daily inhaled medicine called formoterol (Form 12 mcg). The main thing being measured was lung function — specifically how much air participants could forcibly breathe out in one second, known as FEV1. Researchers tracked this over a full 24-hour period after a dose to see how breathing capacity changed compared to each person's starting level. By the end of the study, 182 of the 198 participants had completed the trial. The reported data shows that, for the main measure — average FEV1 change over 24 hours — the placebo group showed almost no change from baseline (−0.004 litres), while the olodaterol dose groups showed increases of 0.135 L (2 mcg), 0.178 L (5 mcg), 0.201 L (10 mcg), and 0.225 L (20 mcg). The formoterol group showed an increase of 0.164 L. The reported data shows similar patterns across the secondary measures: for the first 12-hour window, olodaterol dose groups ranged from 0.124 L to 0.211 L above baseline versus −0.039 L for placebo; for the 12–24 hour window, olodaterol groups ranged from 0.147 L to 0.238 L versus 0.031 L for placebo. The highest single breath reading within 24 hours (peak FEV1) showed changes of 0.326 L to 0.404 L across olodaterol doses, compared with 0.224 L for placebo and 0.390 L for formoterol. The reported data also shows results for "trough" FEV1 — the lung function reading taken just before the next dose was due (around 23–24 hours after the previous dose), which gives an indication of how long any effect lasted. Placebo showed a change of 0.013 L, olodaterol doses ranged from 0.116 L to 0.211 L, and formoterol showed 0.115 L. A separate measure of overall lung capacity (FVC) over the first 12 hours followed a broadly similar pattern, with olodaterol dose groups ranging from 0.056 L to 0.122 L above baseline, compared with −0.047 L for placebo and 0.055 L for formoterol. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00736489 · results posted 3 April 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT00736489) enrolled 37 participants in total, who were divided into six sequence groups. It was a crossover-style trial, meaning each participant tried more than one treatment across multiple periods. The trial was testing a new inhaled medicine called AZD3199 (at three different doses: 120, 480, and 1,920 micrograms) and comparing it against two doses of an existing inhaler medicine called formoterol (9 and 36 micrograms), as well as a placebo (an inactive dummy treatment). The main things being measured were lung function — specifically a breathing test called FEV1 (which measures how much air a person can forcefully breathe out in one second, reported in litres) — and blood potassium levels (a mineral in the blood that can be affected by this type of medicine). The reported data shows that for peak lung function in the 24 hours after a dose, the FEV1 readings were: AZD3199 120 mcg — 3.56 L; AZD3199 480 mcg — 3.62 L; AZD3199 1,920 mcg — 3.70 L; formoterol 9 mcg — 3.62 L; formoterol 36 mcg — 3.69 L; and placebo — 3.44 L. For lung function measured between 22 and 26 hours after the dose (to see how long any effect lasted), the reported figures were: AZD3199 120 mcg — 3.31 L; AZD3199 480 mcg — 3.35 L; AZD3199 1,920 mcg — 3.40 L; formoterol 9 mcg — 3.26 L; formoterol 36 mcg — 3.36 L; and placebo — 3.23 L. For blood potassium levels, the lowest recorded readings in the first four hours were: AZD3199 120 mcg — 4.04 mmol/L; AZD3199 480 mcg — 4.03 mmol/L; AZD3199 1,920 mcg — 3.98 mmol/L; formoterol 9 mcg — 4.04 mmol/L; formoterol 36 mcg — 3.84 mmol/L; and placebo — 4.04 mmol/L. Secondary measures of lung function at 5 minutes post-dose and averaged over the full 24-hour period were also reported, with values across all groups ranging roughly from 3.13 L to 3.47 L and 3.19 L to 3.46 L respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01634620 · results posted 12 February 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 200 people, all of whom completed the study with no drop-outs. All participants were in a single group and underwent a test called FeNO (forced exhaled nitric oxide), which measures a gas in breath that can indicate airway inflammation. The trial was measuring lung function in people with chronic obstructive pulmonary disease (COPD) — a condition that makes it harder to breathe — using a standard breathing test called spirometry. Spirometry asks a person to blow as hard and fast as they can into a device, and the results give information about how well air moves in and out of the lungs. The reported data shows the following average spirometry readings across the 200 participants. The amount of air they could forcefully breathe out in one second (FEV1) was reported as 1.4 litres, which was 53.9% of what would typically be expected for a healthy person of similar age and size — the reported notes state that lower scores on these measures indicate more severe COPD. The total amount of air they could forcefully breathe out altogether (FVC) was 2.68 litres. The speed of airflow at the midpoint of a breath out (FEF50) was reported as 31.8 litres per second, while the average airflow speed across the middle portion of a full breath out (FEF25–75) was 0.759 litres per second. Peak expiratory flow — the fastest speed of air leaving the lungs — was reported as 244.6 litres per minute. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00784459 · results posted 5 February 2014

  According to the results reported on ClinicalTrials.gov, this trial involved 24 people in total — 11 received a placebo (an inactive treatment) and 13 received a medicine called abatacept. All 11 people in the placebo group completed the trial, while 11 of the 13 in the abatacept group completed it (2 did not finish). The trial was measuring levels of a type of immune cell called eosinophils — cells that can be involved in allergic responses — found in the lungs after participants were exposed to an allergen (a substance that triggers an allergic reaction) in a controlled setting. This measurement was taken from fluid collected from the lungs using a procedure called a BAL (broncho-alveolar lavage, a lung washout). The reported data shows two sets of measurements. Before the trial treatment began, the placebo group had an average of 42% eosinophils in their lung fluid following allergen exposure, while the abatacept group had 19%. After approximately three months of receiving either placebo or abatacept, the placebo group's eosinophil percentage was reported as 44%, and the abatacept group's was reported as 17%. These figures represent the proportion of cells in the lung fluid that were eosinophils at each point in time. It is worth noting that the reported data only covers these two primary measurements, and no secondary outcome data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00595153 · results posted 20 January 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled three groups of participants: 24 healthy people (controls), 42 people with asthma who had not used steroid-based inhalers, and 61 people with asthma who were already using inhaled corticosteroid (ICS) treatment — steroid-based inhalers commonly used to manage asthma. Not everyone finished the study; 20 healthy controls, 26 steroid-naive people with asthma, and 36 people with asthma on ICS treatment completed it. The trial was measuring gene activity in airway samples — specifically, looking at three genes linked to a type of airway inflammation associated with a protein called IL-13. These three genes were combined into a single score, called the "three-gene-mean," to give a picture of a particular type of inflammatory pattern in the airways. The reported data shows the following three-gene-mean scores for each group. The healthy control group had a score of −0.66, the steroid-naive asthma group had a score of 0.54, and the asthma group already using inhaled steroids had a score of −0.30. These numbers are on a relative scale — they don't represent a simple physical measurement but rather show how each group's gene activity compared to the overall average across all participants (where zero would be exactly average). No secondary outcome measure data was reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00507130 · results posted 11 December 2013

  According to the results reported on ClinicalTrials.gov, this trial involved 36 people in total, split into four groups of 9. Three groups received different doses of an investigational medicine called MEDI528 (at 0.3, 1, or 3 milligrams per kilogram of body weight), while the fourth group received a placebo (an inactive dummy treatment). The trial was primarily set up to track and count certain health events — including any adverse events (unwanted health occurrences), serious adverse events, abnormal heart readings (ECG), abnormal heart muscle protein levels (troponin, a marker measured in blood), and abnormal MRI scan results. A secondary measure looked at whether participants' bodies produced antibodies (immune proteins) against the study medicine. The reported data shows that all 9 participants in every group experienced at least one adverse event of some kind. When it came to more specific measurements: no participants in any group had abnormal ECG results or abnormal MRI results. One participant in the highest-dose MEDI528 group (3 mg/kg) had a troponin level above the normal range, while no participants in the other groups did. One participant in the placebo group experienced a serious adverse event; none were reported in any of the MEDI528 groups. Regarding the secondary outcome, the reported data shows that no participants in any group developed antibodies against MEDI528. Most participants completed the study — 33 out of 36 finished, with one person not completing in each of the placebo, 1 mg/kg, and 3 mg/kg groups, and all 9 completing in the 0.3 mg/kg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00627679 · results posted 23 October 2013

  According to the results reported on ClinicalTrials.gov, this trial involved 16 people in total, split into four groups of four participants each. All 16 people completed the trial — none dropped out. The trial was looking at how a drug called budesonide (an inhaled medicine used for breathing conditions) was absorbed into the bloodstream under four different treatment conditions: one existing product called Pulmicort Respules® (Treatment A) and three different dose levels of an investigational product called MAP0010 (Treatments B, C, and D). Because this was a "crossover" design, each participant received all four treatments at different times, in a different order depending on their group. The reported data shows the following measurements of budesonide in the blood after each treatment. The peak blood concentration (the highest level of the drug detected) was 303.5 pg/mL for Treatment A, 106.2 pg/mL for Treatment B, 239.9 pg/mL for Treatment C, and 434.5 pg/mL for Treatment D. The time it took to reach that peak was approximately 9.1 minutes for Treatment A, 4.5 minutes for Treatment B, 3.1 minutes for Treatment C, and 3.7 minutes for Treatment D. The total amount of drug absorbed over time (a measure called "area under the curve," which essentially captures the overall exposure to the drug) was also reported and varied across treatments, with Treatment A showing the highest overall exposure figures and Treatment B showing the lowest. The reported "half-life" — the time for the drug level to drop to half its peak — was around 145 minutes for Treatment A, 73 minutes for Treatment B, 78 minutes for Treatment C, and 140 minutes for Treatment D. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01400906 · results posted 30 September 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 35 adults with asthma who were divided into six groups. Each group received all three treatments — a placebo (inactive treatment), a lower dose of fluticasone propionate (FP 100 micrograms), and a higher dose of fluticasone propionate (FP 500 micrograms) — but in a different order, with "washout" rest periods in between. This type of design, where every participant tries each treatment, is called a crossover trial. The trial was measuring how much lung function (specifically, how much air a person can breathe out forcefully in one second, called FEV1) changed after participants were exposed to an allergen, and also looked at markers of airway sensitivity and airway inflammation. The reported data shows the following for the main (primary) outcome — the drop in lung function measured between 4 and 10 hours after allergen exposure (called the "late asthmatic response"). In non-smokers, the average drop in FEV1 compared to a saline (salt water) control day was −1.034 litres with placebo, −0.396 litres with the lower FP dose, and −0.373 litres with the higher FP dose. In smokers, the reported drops were −0.592 litres with placebo, −0.420 litres with the lower dose, and −0.431 litres with the higher dose. For the secondary outcomes, the reported data shows smaller drops in lung function in the first 2 hours after allergen exposure (the "early response") across all three treatments, with figures ranging from roughly −0.68 to −0.98 litres. A separate airway sensitivity test (measuring how the airways reacted to a substance called methacholine) showed higher threshold concentrations — meaning a larger amount was needed to trigger a response — with the FP doses compared to placebo. Levels of exhaled nitric oxide, a marker of airway inflammation, were also reported to be lower with both FP doses than with placebo on both measurement days. Changes in FEV1 measured before the allergen challenge (on Days 1, 6, and 7) were not reported to differ substantially across the three treatments. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01086384 · results posted 11 September 2013

  According to the results reported on ClinicalTrials.gov, this trial involved three groups across two phases. First, 2,183 people took part in a two-week lead-in period where all participants used a common inhaler (fluticasone propionate, or FP 250 µg). Of those, 2,020 completed that phase, and 2,020 were then split into two groups for the main treatment period: 1,011 people received an inhaled medicine called fluticasone furoate (FF 100 µg) alone, and 1,009 received a combination of fluticasone furoate and vilanterol (FF/VI 100/25 µg). The trial was measuring severe asthma flare-ups — defined as a significant worsening of asthma that required steroid tablets, injections, a hospital stay, or an emergency department visit — as well as changes in a lung function measure called FEV1 (the maximum amount of air a person can forcefully breathe out in one second). The reported data shows that, for the main outcome (the number of people who had at least one severe flare-up), 186 out of 1,011 participants in the FF-alone group experienced one or more severe flare-ups, compared with 154 out of 1,009 in the FF/VI combination group. Looking at the total count of all severe flare-up events (since some people had more than one), the reported data shows 271 events in the FF-alone group and 200 events in the FF/VI combination group. For the lung function measure at week 36, the reported data shows that both groups had higher FEV1 readings compared to their starting point — an average increase of 0.265 litres in the FF-alone group, and 0.348 litres in the FF/VI combination group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01147848 · results posted 5 September 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,564 people with asthma into an initial run-in period, of whom 806 went on to the randomised phase. In that phase, 403 participants were assigned to a once-daily inhaler combining fluticasone furoate and vilanterol (FF/VI 100/25 µg), and 403 were assigned to a twice-daily inhaler combining fluticasone propionate and salmeterol (FP/SAL 250/50 µg). The trial's main goal was to measure changes in lung function — specifically a breathing test called FEV1, which captures the maximum amount of air a person can forcefully breathe out in one second — over 24 weeks. The reported data shows that the primary measurement was the average change in FEV1 across a full 24-hour period at week 24, compared to where each participant started. For the FF/VI group, the reported average increase was 0.341 litres, and for the FP/SAL group it was 0.377 litres. For secondary measurements taken over the first four hours after dosing on day one, the reported average increases were 0.316 litres (FF/VI) and 0.346 litres (FP/SAL). At week 24, over the same four-hour window, the reported figures were 0.360 litres (FF/VI) and 0.394 litres (FP/SAL). The reported data also shows that at week 24, 199 participants in the FF/VI group and 178 in the FP/SAL group recorded a lung-function increase of at least 12% and 200 mL at 12 hours after their dose; at 24 hours, those numbers were 181 and 176 respectively. On the first day of treatment, 100 participants in the FF/VI group and 85 in the FP/SAL group showed that same level of increase within the first five minutes of taking their dose. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01136655 · results posted 30 August 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 54 participants and tested five different inhaled treatments across separate periods, with a "washout" break (a rest period to clear the previous treatment from the body) of seven days between each one. The five treatments were four versions of a combination inhaler containing budesonide (BUD 160) paired with different doses of formoterol (FM 2.25, FM 4.5, or FM 9.0), a budesonide-only inhaler (BUD 160), and a budesonide inhaler combined with a separate formoterol product called Foradil 12.0. The trial was measuring how well participants could breathe out forcefully — a standard lung function test called FEV1 (the amount of air a person can breathe out in one second) — over a 12-hour period after taking each treatment. The reported data shows the following average FEV1 readings (in litres) across the 12-hour period after each single dose: BUD 160/FM 2.25 recorded 1.546 L, BUD 160/FM 4.5 recorded 1.594 L, BUD 160/FM 9.0 recorded 1.603 L, BUD 160 alone recorded 1.489 L, and BUD 160/Foradil 12.0 recorded 1.603 L. For the reading taken specifically at the 12-hour mark, the reported figures were 1.641 L, 1.692 L, 1.731 L, 1.626 L, and 1.709 L respectively. The reported highest single FEV1 reading achieved during each 12-hour session was 1.833 L, 1.889 L, 1.884 L, 1.777 L, and 1.892 L for each treatment in the same order. The trial also measured how much formoterol (an ingredient in the combination treatments) passed through participants' bodies and appeared in their urine over 12 hours — this is one way researchers check how much of a medicine the body absorbed. The reported data shows urine formoterol amounts of 192.0 pmol for FM 2.25, 366.3 pmol for FM 4.5, 740.6 pmol for FM 9.0, and 658.7 pmol for Foradil 12.0; this measurement was not reported for the budesonide-only group, as that treatment contained no formoterol. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00603746 · results posted 19 August 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 622 adults across six groups to compare different doses of an investigational inhaled medicine called GW685698X against a placebo (dummy inhaler) and an already-approved inhaled corticosteroid called fluticasone propionate (FP). The doses of GW685698X tested were 200, 400, 600, and 800 micrograms once daily, while FP was given as 500 micrograms twice daily. The main thing being measured was how much a standard breathing test score — called FEV1, which captures how much air a person can forcefully breathe out in one second — changed over eight weeks. Between 65 and 110 participants in each group completed the trial; the placebo group had the highest number of people who did not finish. The reported data shows that, for the primary measure, participants in the placebo group had an average change in their FEV1 of −0.043 litres (a small decline) from their starting point after eight weeks. By comparison, the reported changes for the GW685698X groups ranged from +0.182 to +0.232 litres across the four doses, and the FP group showed a change of +0.155 litres. For the secondary measures, similar patterns were reported across peak flow readings (a separate measure of how fast air can be breathed out), both morning and evening: the placebo group's scores declined slightly on average, while the GW685698X and FP groups all showed increases. For example, morning peak flow changes averaged −7.3 litres per minute for placebo, compared with a range of +16.7 to +20.9 litres per minute across the GW685698X doses, and +16.5 litres per minute for FP. The reported data also shows changes in the percentage of days participants recorded no asthma symptoms and no need for their "rescue" inhaler. Symptom-free days increased by an average of 6.4 percentage points in the placebo group, compared with 15.1 to 20.1 percentage points across the GW685698X doses and 15.4 percentage points for FP. Rescue-inhaler-free days increased by 3.6 percentage points for placebo, versus 17.4 to 22.3 percentage points for the GW685698X doses and 16.7 percentage points for FP. Regarding withdrawals due to the treatment not seeming to work well enough, 34 participants in the placebo group left for this reason, compared with 6 to 12 across the GW685698X groups and 8 in the FP group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00603278 · results posted 12 August 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 615 adults across six groups over an 8-week period. Participants were randomly assigned to receive either a placebo (dummy treatment), one of four doses of an inhaled corticosteroid called GW685698X (given once daily at 100, 200, 300, or 400 micrograms), or a comparator inhaled corticosteroid called fluticasone propionate (FP, given twice daily at 250 micrograms). The trial was primarily measuring changes in lung function — specifically a breathing test called FEV1, which measures how much air a person can forcefully breathe out in one second. A number of secondary measures were also tracked, including peak airflow readings, symptom-free days, and days without needing rescue medication. The reported data shows that for the main lung function measure (FEV1) at 8 weeks, the placebo group's average score fell by 0.065 litres from their starting point, while all active treatment groups showed increases: the GW685698X groups rose by 0.142, 0.173, 0.228, and 0.215 litres (lowest to highest dose), and the FP group rose by 0.160 litres. For evening peak airflow, the placebo group fell by 2.8 litres per minute on average, while the active groups rose by between 9.1 and 21.0 litres per minute (GW685698X) and 18.2 litres per minute (FP). Morning peak airflow showed a similar pattern. For symptom-free days, the reported average increase ranged from 17.1 percentage points in the placebo group up to 30.4 percentage points in the FP group, with GW685698X groups ranging from 19.4 to 28.0. For days without needing rescue medication, the placebo group reported a 15.6 percentage point increase, compared to 23.8–25.0 for GW685698X groups and 34.5 for the FP group. The reported data also shows that 35 people in the placebo group withdrew due to lack of effect, compared to 7–14 people across the active treatment groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00600171 · results posted 12 August 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 607 adults across six groups to test five different doses of an inhaled medicine called GW642444M (at 3, 6.25, 12.5, 25, and 50 micrograms) compared to a dummy treatment (placebo). The main thing being measured was how much a breathing test score — called FEV1, which measures how much air a person can forcefully breathe out in one second — changed over a 28-day treatment period. Several secondary measures were also tracked, including two different at-home airflow readings (morning and evening), and how often participants went a full 24 hours without symptoms. The reported data shows that, for the primary measure (change in FEV1 at the end of 28 days), the placebo group's average score increased by 0.147 litres from their starting point, while the five GW642444M dose groups showed average increases ranging from 0.212 litres (lowest dose, 3 µg) up to 0.309 litres (highest dose, 50 µg). For the secondary breathing measures taken at home, the reported data shows the placebo group's average evening airflow score changed by about 0.4 litres per minute, compared to changes ranging from 14.0 to 38.4 litres per minute across the GW642444M groups; morning airflow figures followed a similar pattern, ranging from 18.7 to 44.0 litres per minute in the active dose groups versus 1.9 litres per minute for placebo. For symptom-free 24-hour periods, the placebo group showed an average increase of about 14.2 percentage points, while the GW642444M groups showed increases ranging from roughly 22.6 to 36.4 percentage points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01128595 · results posted 9 August 2013

  According to the results reported on ClinicalTrials.gov, 27 people took part in this trial (across four groups receiving treatments in different orders). It was a "crossover" trial, meaning every participant tried each of the four treatments one at a time — a placebo (inactive inhaler), fluticasone furoate alone (FF 100 µg), vilanterol alone (VI 25 µg), and a combination of the two (FF/VI 100/25 µg) — with washout periods in between. The trial was measuring how much lung function changed after participants were exposed to an allergen (a substance known to trigger an asthmatic reaction). Lung function was measured using a test called FEV1 — broadly, how much air a person can forcefully breathe out in one second — looking at both an "early" response (in the first two hours after allergen exposure) and a "late" response (between four and ten hours after exposure). The reported data shows the following results for the primary outcomes, expressed as the change in litres of air compared to a saline (saltwater) control. For the early response, the lowest single FEV1 reading recorded was: placebo −1.091 L, FF/VI combination −0.614 L, FF alone −0.826 L, and VI alone −0.955 L. The average early response over the full two-hour window was: placebo −0.560 L, FF/VI −0.297 L, FF alone −0.386 L, and VI alone −0.533 L. For the late response, the lowest single FEV1 reading was: placebo −0.731 L, FF/VI −0.216 L, FF alone −0.188 L, and VI alone −0.536 L. The average late response over the four-to-ten-hour window was: placebo −0.466 L, FF/VI +0.018 L, FF alone +0.018 L, and VI alone −0.298 L. The reported secondary outcomes included a measure of the maximum percentage drop in lung function in the first two hours (placebo −26.13%, FF/VI −10.43%, FF alone −16.14%, VI alone −18.35%), and a separate airway sensitivity test the following day where higher numbers indicate less sensitivity (placebo 1.046 mg/mL, FF/VI 2.500 mg/mL, FF alone 2.492 mg/mL, VI alone 0.387 mg/mL). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00766090 · results posted 7 August 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 205 participants across 12 groups, with each person trying three different treatments in a set order — separated by two-week "washout" breaks in between. The treatments compared were a placebo (dummy inhaler with no active ingredient), two versions of a medicine called fluticasone furoate (FF) — one dose taken once a day, another taken twice a day — and two versions of a different medicine called fluticasone propionate (FP), also given once or twice a day. The main thing the trial was measuring was how well participants could breathe out forcefully after 28 days on each treatment, using a standard breathing test called FEV1 (the amount of air a person can push out in one second). The reported data shows that after 28 days, the average FEV1 reading for participants on placebo was 2.605 litres. For FF once a day it was 2.714 litres, for FF twice a day it was 2.703 litres, for FP once a day it was 2.693 litres, and for FP twice a day it was 2.737 litres. The trial also looked at a number of other measurements. For adverse events (unexpected medical occurrences during the trial), the reported data shows that 26 participants experienced at least one such event on placebo, 22 on FF once a day, 26 on FF twice a day, 2 on FP once a day, and 3 on FP twice a day; no serious adverse events were reported in any group. A urine test measuring a hormone called cortisol (which can reflect how a medicine affects the body's natural stress response) recorded 53.94 nanomoles per 24 hours on placebo, compared to 40.25 for FF once a day, 45.13 for FF twice a day, 56.16 for FP once a day, and 47.56 for FP twice a day. No participants showed signs of a mouth or throat fungal infection (oral thrush) in any group. Blood pressure and heart rate figures at the check-in and end-of-treatment visits were also reported and appeared broadly similar across groups, though some figures for individual time points were not fully reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01316380 · results posted 31 July 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT01316380) involved 465 people across three groups: 156 received a placebo (a dummy treatment with no active ingredient), 154 received a lower dose of a medicine called Tiotropium Respimat 2.5 micrograms (Tio R2.5), and 155 received a higher dose of Tiotropium Respimat 5 micrograms (Tio R5). The vast majority of participants finished the study — 154, 149, and 152 people respectively. The trial was measuring changes in lung function over 12 weeks, primarily looking at how much air participants could forcefully breathe out in one second (called FEV1), both shortly after taking the medication and before the next dose was due. The reported data shows that for the main measurement — the peak FEV1 reading within three hours of taking the dose after 12 weeks — the placebo group showed a change of 0.134 litres from their starting point, while the Tio R2.5 group showed a change of 0.293 litres and the Tio R5 group showed a change of 0.262 litres. For a secondary measure looking at lung function just before the next scheduled dose (called "trough FEV1"), the reported changes from baseline were 0.015 litres for placebo, 0.125 litres for Tio R2.5, and 0.137 litres for Tio R5. Other secondary measures of lung capacity (FVC) and average lung function over three hours showed a similar pattern of reported numbers across the three groups. For an asthma control questionnaire (scored 0–6, where lower is better), the reported number of participants whose scores improved by a meaningful amount were 91 in the placebo group, 91 in the Tio R2.5 group, and 90 in the Tio R5 group, while those whose scores worsened were 2, 10, and 5 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01165138 · results posted 30 July 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 609 participants across three treatment groups: 203 received a placebo (an inactive treatment), 205 received a medicine called fluticasone furoate (FF) at 100 micrograms once daily, and 201 received a combination of fluticasone furoate and vilanterol (FF/VI) at 100/25 micrograms once daily. There was also a reference group listed with zero participants. The trial ran for 12 weeks and was primarily measuring changes in lung function — specifically how much air participants could forcefully breathe out in one second (called FEV1), both at a single clinic measurement and averaged over a 24-hour period. The reported data shows that for the single clinic lung function measurement, the placebo group's score increased by an average of 0.196 litres from their starting point, the FF group increased by 0.332 litres, and the FF/VI group increased by 0.368 litres. For the 24-hour averaged lung function measurement, the placebo group increased by 0.212 litres, the FF group by 0.398 litres, and the FF/VI group by 0.513 litres. These are changes from each participant's own starting measurement — not comparisons between people. The reported data also shows results for several secondary measures. The percentage of days participants went without needing rescue medication increased from their starting point by 17.8 percentage points in the placebo group, 26.5 in the FF group, and 37.1 in the FF/VI group. Similarly, the percentage of symptom-free days increased by 14.6, 20.4, and 32.5 percentage points respectively. A quality-of-life questionnaire (scored 1–7, where higher means less impairment) showed average increases of 0.61, 0.76, and 0.91 points across the three groups. Finally, the number of participants who left the trial early due to their condition not improving was 32 in the placebo group, 6 in the FF group, and 7 in the FF/VI group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00280683 · results posted 5 June 2013

  According to the results reported on ClinicalTrials.gov, this trial looked at whether taking arginine (an amino acid supplement) made a difference to the number of asthma flare-ups compared to a dummy treatment (placebo) over three months. Twenty people took part in total — ten in the arginine group and ten in the placebo group. Of those, eight in the arginine group and seven in the placebo group finished the study, with two and three participants respectively not completing it. The reported data shows that the main thing being measured was the number of asthma flare-ups (called "exacerbations") over the three-month period. A flare-up was counted if any one of three things happened: a significant drop in a breathing test called peak expiratory flow, a need to increase preventer medication, or a doubling of reliever puffer use on two days in a row. The arginine group recorded 30 flare-ups in total, while the placebo group recorded 31. For a secondary measure, the trial also looked at levels of arginine in the blood — the arginine group had a reported level of 0.002 pmol/100µl compared to 0.0011 pmol/100µl in the placebo group. No further breakdown of these figures was reported in the submitted data. It is worth noting that this was a very small trial, and the results as submitted do not include any further statistical analysis to help interpret what these numbers mean. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01348139 · results posted 5 March 2013

  According to the results reported on ClinicalTrials.gov, this was a small crossover trial — meaning each participant took turns receiving different treatments over multiple periods — involving 26 people in total (one person withdrew early from the first period). The trial was testing a drug called AZD3199, given by inhalation at five different doses (300 µg, 800 µg, 880 µg, 1,200 µg, and 1,400 µg), compared to a dummy treatment (placebo). The main thing being measured was lung function, specifically a breathing test called FEV1 — which measures how much air a person can breathe out forcefully in one second, recorded in litres. The trial tracked both the highest FEV1 reading in the 24 hours after a dose, and the average FEV1 reading between 22 and 26 hours after a dose (to see how lung function looked toward the end of the dosing period). The reported data shows that for the peak FEV1 reading over 24 hours, the five AZD3199 doses produced values ranging from approximately 3.76 to 3.85 litres, while the placebo group recorded approximately 3.50 litres. For the later (22–26 hour) FEV1 reading, the AZD3199 doses ranged from roughly 3.45 to 3.57 litres, compared to approximately 3.31 litres for placebo. The reported data also shows that for the average FEV1 across the full 24 hours, AZD3199 doses ranged from about 3.49 to 3.64 litres versus 3.29 litres for placebo. At the very early 5-minute mark after dosing, FEV1 readings for AZD3199 ranged from roughly 3.41 to 3.50 litres, compared to about 3.19 litres for placebo. For the secondary measures, the reported data shows that the time to reach the peak FEV1 reading varied by dose — from 1 to 4 hours for AZD3199 doses, compared to 10 hours for placebo. Peak pulse rate (heartbeats per minute) in the first 4 hours was reported as ranging from about 64 to 66 beats per minute across all groups, including placebo (64 beats per minute). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00723021 · results posted 1 February 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT00723021) enrolled 15 people in total — split across five groups of 3 participants each. It was a crossover study, meaning each person went through multiple treatment periods, trying different treatments in a set sequence. The trial was measuring how different doses of an investigational medicine called PF-04191834 (at 30 mg, 100 mg, and 2000 mg doses) compared to a placebo (a dummy treatment with no active ingredient) and to an existing medicine called Zileuton CR (1200 mg). The main thing being measured was lung function — specifically how much air participants could forcefully breathe out in one second (known as FEV1), as well as a couple of other breathing measurements. The reported data shows that at the start (baseline), FEV1 readings were similar across all groups, ranging from about 2.58 to 2.63 litres. The changes from that starting point varied across the treatment periods. In one measurement period, the reported changes in FEV1 were: placebo +0.064 L, PF-04191834 30 mg +0.164 L, PF-04191834 100 mg +0.152 L, PF-04191834 2000 mg +0.265 L, and Zileuton CR +0.131 L. In a second measurement period, the reported changes were: placebo +0.122 L, PF-04191834 30 mg +0.014 L, PF-04191834 100 mg +0.103 L, PF-04191834 2000 mg +0.162 L, and Zileuton CR +0.151 L. Similar patterns of small changes from baseline were also reported for the secondary breathing measurements (FVC and FEF25-75). All but one participant completed the full trial — one person in Treatment Sequence 5 did not complete the fourth intervention period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00686335 · results posted 28 December 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants in an initial "run-in" phase, of whom 7 went on to complete the main treatment period. The trial was measuring nocturnal awakenings — that is, the number of times participants woke during the night — comparing two different formulations of a corticosteroid medicine (Lodotra and Cortancyl) over the final two weeks of each treatment phase. The reported data shows that during the last two weeks of the Cortancyl phase, participants recorded an average of 10.0 nocturnal awakenings in total, while during the last two weeks of the Lodotra phase, the recorded average was 2.1 nocturnal awakenings in total. No other outcome measures were included in the results data submitted to ClinicalTrials.gov for this trial. It is worth noting that only 7 people completed the full trial, which is a very small number. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00839800 · results posted 30 November 2012

  According to the results reported on ClinicalTrials.gov, this trial involved 1,049 people in one group ("Symbicort SMART") and 1,042 people in a second group ("Symbicort + Terbutaline as needed") — a total of 2,091 participants. The trial ran for 52 weeks and was measuring asthma-related outcomes, including how many people experienced a serious worsening of their asthma (defined as a flare-up requiring steroid tablets, a hospital stay, or an emergency room visit), as well as breathing measurements and how often participants needed to use their reliever inhaler. The reported data shows that, by the end of the study, 16% of participants in the Symbicort SMART group had experienced at least one serious asthma flare-up, compared with 22% in the Symbicort + Terbutaline group. Looking at the total count of flare-ups across the 52 weeks, the reported data shows 259 flare-ups in the SMART group and 363 in the other group. For breathing measurements — taken using devices that measure how much air a person can breathe out — the reported averages were similar between the two groups, with small numerical differences across all time points. The reported data also shows that, on average, participants in the SMART group used their reliever inhaler about 1.21 times per day, compared with 1.46 times per day in the other group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00776984 · results posted 27 September 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 234 people in the placebo group and 219 people in the active treatment group (called "Tio R5," a tiotropium inhaler). Of those, 203 and 198 people respectively completed the trial. The trial was measuring lung function in people with asthma over a 24-week treatment period. Specifically, it looked at how much participants' breathing capacity changed after taking their medication, using a breathing test called FEV1 (how much air a person can forcefully breathe out in one second) and FVC (the total amount of air breathed out in one breath). The reported data shows that after 24 weeks, the peak improvement in FEV1 in the first three hours after dosing was 0.248 litres in the placebo group and 0.401 litres in the Tio R5 group. For the "trough" FEV1 — meaning the lung function measured just before the next dose was due (reflecting the longer-lasting carry-over effect) — the reported improvement was 0.044 litres for placebo and 0.155 litres for Tio R5. A third primary outcome looked at the time until a first severe asthma flare-up, combining data from this trial and a companion trial over 48 weeks; however, the specific numbers for that outcome were not reported in the data submitted to ClinicalTrials.gov. The reported data also shows results for additional (secondary) measures. The peak improvement in FVC within three hours of dosing was 0.323 litres for placebo and 0.416 litres for Tio R5. The trough FVC improvement was 0.044 litres for placebo and 0.150 litres for Tio R5. A further measure — the average FEV1 improvement across the full three hours after dosing — was reported as 0.164 litres for placebo and 0.307 litres for Tio R5. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00772538 · results posted 27 September 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 459 people with asthma — 222 in a placebo (dummy treatment) group and 237 in a group receiving a medicine called tiotropium Respimat 5 micrograms (referred to here as "Tio R5"). The trial ran for 24 weeks and was primarily measuring changes in lung function, specifically using a breathing test called FEV1 (the amount of air a person can forcefully breathe out in one second) and FVC (the total amount of air breathed out in one breath). It also set out to measure the time until a first severe asthma flare-up, using pooled data combined from this trial and a companion trial. The reported data shows that, for the main lung function measures after 24 weeks, both groups showed increases from their starting points. For the peak breathing-test reading taken within three hours of dosing, the placebo group showed an average increase of 0.315 litres, while the Tio R5 group showed an average increase of 0.401 litres. For the "trough" reading — a measurement taken just before the next dose, reflecting how lung function looked at its lowest point — the placebo group showed an average increase of 0.056 litres and the Tio R5 group showed an average increase of 0.144 litres. Similar patterns were reported for the FVC breathing measure, with the placebo group recording increases of 0.355 litres (peak) and 0.022 litres (trough), and the Tio R5 group recording increases of 0.445 litres (peak) and 0.157 litres (trough). For the third primary outcome — time to a first severe asthma flare-up across the combined trial data — no numerical result was reported in the submitted data. The reported data shows that a further lung function measure (an average reading across the three hours after dosing, called AUC0-3h) was also recorded: the placebo group showed an average increase of 0.229 litres and the Tio R5 group showed an average increase of 0.315 litres from their starting points. These numbers represent averages across all participants in each group and were adjusted to account for differences between study sites, time points, and starting values. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00628758 · results posted 14 August 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT00628758) enrolled 430 people with asthma — 209 in the Symbicort group and 221 in the Conventional Best Practice (BP) group. By the end of the study, 165 and 179 people in each group respectively had completed it. The trial was measuring how long it took for participants to have a serious asthma flare-up, as well as the total number of serious flare-ups, quality of life, and how often participants used their reliever (as-needed) medication each day. The reported data shows that, for the primary outcome, the average time to a first serious asthma flare-up was 120.3 days in the Symbicort group and 103.7 days in the Conventional BP group. For the secondary outcomes, both groups had the same total number of serious flare-ups recorded — 10 in each group. Quality of life was measured using a standardised questionnaire scored from 1 (greatest impairment) to 7 (least impairment); the reported scores were 3.98 for the Symbicort group and 3.97 for the Conventional BP group. For daily reliever medication use, the Symbicort group reported an average of 0.91 puffs per day, compared with 0.68 puffs per day in the Conventional BP group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00712335 · results posted 16 May 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 105 participants across five groups: asthmatic smokers receiving a combination treatment (8 started, 5 completed), asthmatic smokers receiving montelukast only (32 started, 15 completed), non-smoking asthmatics receiving combination treatment (11 started, 6 completed), non-smoking asthmatics receiving montelukast only (24 started, 19 completed), and a group of healthy non-asthmatic, non-smoking volunteers used as a reference point (30 started and completed). The trial measured various markers of airway inflammation — substances found in mucus samples coughed up by participants — over 24 weeks, to compare levels across the different groups. The reported data shows that the main measurement — the percentage of a type of immune cell called neutrophils found in mucus samples at 24 weeks — ranged from about 72% to 89% across the four treatment groups. Asthmatic smokers on combination therapy had the highest reported level (86%), while asthmatic smokers on montelukast only had the lowest (approximately 73%). For a second immune cell type called eosinophils, reported percentages were lower overall, ranging from about 1.6% to 3.6% across the groups. The reported data also shows levels of several other inflammatory substances measured in mucus samples, including IL-8, GM-CSF, eotaxin, and an immune signalling ratio (IFN-gamma to IL-5). These figures varied across groups, but no results for the healthy volunteer reference group were reported for any of the outcome measures in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00461500 · results posted 23 March 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 81 children in total — 37 in the SFC group (a combination of salmeterol and fluticasone) and 44 in the FP group (fluticasone alone). By the end of the study, 30 and 38 participants respectively had completed the trial. The trial was measuring changes in how well the children could breathe over a 12-week period, using devices that track how fast and how much air a person can blow out of their lungs. The reported data shows that the main thing being measured was the change in morning peak flow — that is, how fast the children could blow air out first thing in the morning, measured in litres per minute. The SFC group showed an average increase of about 59 litres per minute from their starting point, while the FP group showed an average increase of about 51 litres per minute. For the secondary breathing measurements, the reported data shows the SFC group had a change of +0.25 litres in the amount of air blown out in one second (FEV1), compared to +0.11 litres in the FP group. When expressed as a percentage of what would be considered normal for their age and size, those figures were roughly +7.5% for the SFC group and +5.0% for the FP group. A measure of airway "reversibility" (how much the airways responded to a reliever medication) showed changes of -9.46% and -4.05% respectively, where a negative number indicates less reversibility at the end of the study compared to the start. Other breathing measurements showed similarly small numerical differences between the two groups, all as reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00643578 · results posted 18 November 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people in total, split into two groups of six. One group received a lower dose of a medicine called formoterol (12 micrograms) first, and the other group received a higher dose (24 micrograms) first. The trial was measuring how the two doses affected the airways, using two tests: one that checks how sensitive the airways are to a substance called methacholine, and one that measures how much air a person can forcefully breathe out in one second. The reported data shows that the key measurement — called PC20, which is the amount of methacholine needed to cause a notable drop in airflow — was 7 mg/mL for the group that received the 12-microgram dose, and 16 mg/mL for the group that received the 24-microgram dose. In plain terms, a higher PC20 number means the airways were less reactive to the test substance at the time of measurement. For the second measurement — the amount of air breathed out forcefully in one second, shown as a percentage of what would be expected for a typical person of the same age and size — the reported data shows a result of 88% for the 12-microgram group and 91% for the 24-microgram group. It is also worth noting that two participants in one group did not complete the trial, though the reason was not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00314574 · results posted 13 October 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 850 people in total — 423 in the placebo group and 427 in the Xolair (omalizumab) group — and ran over 48 weeks. The trial was measuring asthma flare-ups (defined as worsening symptoms needing steroid treatment for three or more days) as its main focus, along with several secondary measures including asthma symptom scores, use of reliever puffer medication, and asthma-related quality of life. Around 329 people in the placebo group and 344 in the Xolair group completed the full study period. The reported data shows that over the 48-week period, the placebo group had a rate of 0.88 flare-ups per patient per week, while the Xolair group had a rate of 0.66 flare-ups per patient per week. For asthma symptom scores (on a scale of 0–9, where higher means worse), both groups improved from their starting point: the placebo group's score decreased by 1.36 points and the Xolair group's by 1.61 points. For reliever puffer use, the placebo group used an average of 1.35 fewer puffs per day by week 48, compared to 1.57 fewer puffs per day in the Xolair group. On the quality-of-life questionnaire (scored 1–7, where higher means better), the placebo group's score improved by 0.96 points and the Xolair group's by 1.16 points from their starting levels. Adverse event data was collected for 420 participants in the placebo group and 428 in the Xolair group, though the specific details of those events were not included in the structured results data reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00831428 · results posted 23 September 2011

  According to the results reported on ClinicalTrials.gov, this trial involved 97 members of the Scottish Swimming Team. All 97 participants who started the study completed it, with none dropping out. The trial was measuring several things related to breathing and airway health in competitive swimmers, including levels of a gas called nitric oxide (a naturally occurring substance in the body that can be measured in exhaled breath as an indicator of airway inflammation), as well as responses to breathing challenges and nasal health tests. The reported data shows that for the main (primary) outcome — a measure of nitric oxide in normal breathing, called "tidal nitric oxide" — the average recorded level across the group was 18.7 parts per billion (ppb), which is simply a way of expressing how much of the gas was present in the breath. For the remaining six measurements that were listed as secondary outcomes — including a mannitol breathing challenge, a sport-based breathing challenge, nasal nitric oxide levels, a skin prick test, and a nasal fluid sample — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00614874 · results posted 2 September 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 16 people, all of whom received a medicine called rosiglitazone. Fourteen participants completed the study, while two did not finish. The trial was measuring how the airways responded to a chemical challenge (methacholine), as well as several measures of lung function and airway inflammation, before and after taking the medicine. The reported data shows the following numbers for the group as a whole. For the main measurement — called PC20, which is the amount of methacholine needed to cause a 10% drop in a standard breathing test — the two reported values were 3.27 mg/mL and 8.71 mg/mL. For exhaled nitric oxide (a marker measured in the breath, reported in parts per billion), the two reported values were 48 and 41. For the breathing test known as FEV1 (roughly, how much air a person can blow out in one second), the reported values were 2.95 litres and 3.04 litres. Finally, FEV1 expressed as a percentage of what would be expected for a person of similar age and size was reported as 82% and 85%. The data does not clearly label which of each pair of values was measured at the start versus the end of the study, so it is not possible to say more about the order from the information provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01079130 · results posted 19 August 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 511 people across six groups to compare four different doses of an inhaled medicine called indacaterol (18.75 µg, 37.5 µg, 75 µg, and 150 µg) against another inhaled medicine called salmeterol and an inactive placebo (a dummy treatment). Each group had around 84–86 participants at the start. The trial was measuring how well people could breathe out after two weeks of treatment, using a standard breathing test called FEV1 — this measures the amount of air a person can forcefully breathe out in one second, recorded in litres. A higher number generally means more air was breathed out. The reported data shows that after two weeks of treatment, the average trough FEV1 (that is, the breathing measurement taken roughly 23–24 hours after the last dose, representing the lowest point before the next dose) was 2.50 litres for the indacaterol 18.75 µg group, 2.52 litres for the 37.5 µg group, 2.59 litres for the 75 µg group, 2.54 litres for the 150 µg group, 2.54 litres for the salmeterol group, and 2.42 litres for the placebo group. The reported data also shows results after just one day of treatment: 2.46 litres (18.75 µg), 2.52 litres (37.5 µg), 2.54 litres (75 µg), 2.60 litres (150 µg), 2.65 litres (salmeterol), and 2.45 litres (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00393367 · results posted 25 July 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 179 participants — 91 in the group that received budesonide inhalation suspension (a corticosteroid inhaled treatment, referred to as BIS) alongside the standard reliever medicine albuterol, and 88 in a placebo (salt water) group who received albuterol alone. The trial was measuring how much participants' asthma symptoms changed over a two-hour period, using a scoring system called the Asthma Score, which runs from 5 (mildest) to 15 (most severe). Most participants completed the study — 89 in the BIS group and 81 in the placebo group. The reported data shows that the main thing being measured — the change in asthma score after two hours — was the same in both groups. Both the BIS group and the placebo group had a median (middle value) drop of 3 points on the asthma scale. For the other measurements, the reported numbers were also very similar between groups: heart rate dropped by around 12–13 beats per minute in both groups, breathing rate decreased by 6 breaths per minute in both groups, and blood oxygen levels rose by 1 percentage point in both groups. Of the participants who started with the most severe asthma scores, 4 people in each group remained in that severe category two hours later. The reported data also shows that 56 participants in the BIS group and 55 in the placebo group were admitted to hospital within four hours, again a similar result between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00500539 · results posted 27 April 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 155 people who all received the medication omalizumab (in a liquid form) over a 24-week treatment period, followed by a 16-week follow-up period. The trial was primarily looking at whether the body developed a particular type of immune response — called a "human anti-human antibody" (HAHA) response — to omalizumab. In simple terms, this means the researchers were checking whether participants' immune systems started producing proteins that recognised and targeted the medication itself. The trial also tracked unwanted health events (called adverse events) that occurred during both the treatment and follow-up periods. The reported data shows that, by the end of the 16-week follow-up, zero out of the participants tested showed a confirmed positive HAHA result — meaning none of the participants were found to have developed that particular immune response to the medication. Regarding unwanted health events during the 28-week treatment period (which included an extra 4 weeks of monitoring), the reported data shows that 124 out of 155 participants experienced at least one adverse event of any kind, and 25 experienced a serious adverse event (defined as one involving hospitalisation, being life-threatening, or another significant medical event). During the subsequent 12-week follow-up reporting period, 51 participants experienced at least one adverse event, and 11 experienced a serious adverse event. The data does not provide a full breakdown of what each individual adverse event figure represents beyond these overall counts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00460577 · results posted 19 April 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in each of two groups — one group received a medication called Formoterol (Foradil®), and the other received a combination treatment called Fenoterol 0.5 mg + Berodual®. The trial was measuring changes in breathing function over time, using several tests including how much air a person can forcefully breathe out, blood oxygen levels, and a clinical scoring system that rates breathing symptoms like wheezing and use of extra breathing muscles. Of the 60 people who started, 28 in the Formoterol group and 24 in the Fenoterol/Berodual group completed the trial. The reported data shows the following changes from the start of the trial to the final check-up. For the amount of air breathed out forcefully in one second (a common breathing test), the Formoterol group showed an average increase of 0.32 litres and the Fenoterol/Berodual group showed 0.34 litres. For peak airflow speed (how fast air moves out), the reported average increases were 44 litres per minute and 43.67 litres per minute respectively. Blood oxygen levels (measured as a percentage) rose by an average of 2.57% in the Formoterol group and 2.83% in the Fenoterol/Berodual group. On the symptom scoring scale (where lower scores mean fewer symptoms, out of a possible 9 points), both groups showed an average decrease of around 3 points — minus 3.18 for Formoterol and minus 3.04 for Fenoterol/Berodual. The reported data shows that detailed safety results were not posted to ClinicalTrials.gov for this trial. The trial also looked at the average cost per prescription for each treatment. The reported data shows the average direct cost was US$9.21 for Formoterol and US$25.67 for the Fenoterol/Berodual combination. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00381485 · results posted 7 March 2011

  According to the results reported on ClinicalTrials.gov, this trial involved 834 adults who first went through an open-label "run-in" phase where everyone took the same inhaled asthma medicine (mometasone furoate, or MF) twice a day. Of those 834 people, 728 completed that phase and 728 were then randomly assigned to one of three groups for a 12-week double-blind period (meaning neither the participants nor researchers knew who was receiving which treatment): a higher-dose combination inhaler (MF/F 400/10 mcg, 255 people), a lower-dose combination inhaler (MF/F 200/10 mcg, 233 people), or a single-medicine inhaler (MF 400 mcg alone, 240 people). The trial was primarily measuring changes in lung function — specifically how much air participants could blow out in one second (called FEV1) — over a 12-hour window at week 12, compared to where they started. The reported data shows that for the main lung function measure, the higher-dose combination group recorded an average result of 4.19 litre-hours, the lower-dose combination group recorded 3.59 litre-hours, and the single-medicine group recorded 2.04 litre-hours (these figures represent the total change in breathing capacity tracked across the 12-hour period). For the secondary measures, an asthma control questionnaire (scored 0–6, where lower is better) showed changes from the starting point of −0.58, −0.59, and −0.42 for the three groups respectively. A quality-of-life questionnaire (scored 1–7, where higher is better) showed changes of +0.51, +0.61, and +0.50. The reported data also shows that the proportion of nights participants woke due to asthma needing a reliever inhaler changed by −0.10, −0.10, and −0.05 across the three groups (on a scale of 0 to 1). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00277446 · results posted 24 February 2011

  According to the results reported on ClinicalTrials.gov, this trial involved 13 participants who all completed the study — none dropped out. Every participant received a soy isoflavone supplement. The trial was measuring three things: a marker of airway inflammation detected in breath (called exhaled nitric oxide), a chemical produced by certain immune cells (called LTC4, made by cells known as eosinophils), and how much air a person can forcefully breathe out in one second (a standard breathing test known as FEV1). The reported data shows that, at the start of the study, the average exhaled nitric oxide level was 67.0 parts per billion, and at four weeks it was recorded at 54.8 parts per billion. For the immune cell chemical (LTC4), the reported average started at 3.11 ng/ml and was recorded at 2.07 ng/ml at the end of the study period. For the breathing test (FEV1 — the amount of air breathed out forcefully in one second), the reported average was 2.59 litres per second at the start and 2.56 litres per second at the end. These are simply the numbers recorded at two points in time; the data as submitted does not include statistical analysis figures to indicate how meaningful any differences between those two time points may be. It is also worth noting that with only 13 participants and no comparison group receiving a different or inactive treatment, the scope of what this data can tell us is limited. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00442117 · results posted 10 February 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 85 people in the MF-DPI group and 87 people in the BUD-DPI group — two different inhaled asthma medications delivered via dry powder inhaler. Of those, 47 and 49 people respectively completed the full 12 weeks. The trial was measuring changes in how well participants' lungs were working, using several breathing tests taken at the start of the trial and again at week 12. The reported data shows the following percentage changes in lung function from the start to week 12. For the primary measure — how much air a person can forcefully breathe out in one second (FEV1) — the MF-DPI group showed an average change of −1.09% and the BUD-DPI group showed an average change of −0.02%. For a broader measure of total air breathed out (FVC), the MF-DPI group showed −0.11% and the BUD-DPI group showed −0.88%. For a measure of airflow through the mid-range of a breath (FEF 25–75%), the MF-DPI group showed +0.01% and the BUD-DPI group showed +1.72%. For morning peak flow rate — how fast air can be blown out — the MF-DPI group showed +2.59% and the BUD-DPI group showed +1.93%. All of these figures represent small percentage changes from each group's own starting point, as reported by the trial sponsor. The reported data shows only what was measured and the numbers recorded; no conclusions about which treatment performed better should be drawn from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00231114 · results posted 29 November 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 297 people with asthma — 196 in the Alair (treatment) group and 101 in the sham (control) group, where the sham group went through a similar procedure without the active treatment. The trial was measuring changes in asthma-related quality of life over 12 months, along with several other asthma-related measures such as symptom-free days, symptom scores, and use of quick-relief ("rescue") medication. The reported data shows that for the main outcome — a quality of life questionnaire scored from 1 to 7, where higher numbers mean better quality of life — both groups reported improvements from their starting scores. The Alair group's average score increased by 1.35 points, while the sham group's increased by 1.16 points. For the other reported measures, both groups also showed changes in the same direction: the percentage of symptom-free days increased by about 24% in the Alair group and 21% in the sham group; overall symptom scores fell by 1.7 points (Alair) and 1.6 points (sham) out of a maximum possible score of 18; weekly puffs of rescue medication decreased by about 6 puffs (Alair) and 4.3 puffs (sham); the percentage of days rescue medication was used fell by 24% (Alair) and 22% (sham); and an asthma control questionnaire score (lower is better) dropped by 0.82 points (Alair) and 0.77 points (sham). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00818454 · results posted 23 November 2010

  According to the results reported on ClinicalTrials.gov, this trial involved two separate parts. The first part was a crossover study, meaning the same participants tried both treatments in a random order with a one-week break in between — 115 people started on one sequence and 111 on the other, with most completing both periods. A separate, parallel part of the trial involved 26 people receiving a placebo (dummy inhaler) and 139 receiving Combivent Respimat. The trial was measuring lung function, quality of life, asthma symptom control, and inhaler use in people with asthma, comparing two inhaled medicines: Albuterol HFA (a reliever inhaler) and Combivent CFC (a combination inhaler). The reported data shows that, for the main lung function measures after four weeks, participants using Albuterol HFA had an average improvement of 0.167 litres in overall breathing capacity over six hours (known as FEV1 AUC0–6, a measure of how much air someone can breathe out), while those using Combivent CFC had an average improvement of 0.252 litres. For the best single breathing effort recorded (peak FEV1), the reported average improvement was 0.357 litres for Albuterol HFA and 0.434 litres for Combivent CFC. These numbers represent changes from each participant's starting point, not absolute lung capacity values. The reported data shows that on a quality-of-life questionnaire (scored 1–7, where higher is better), both groups improved slightly from their starting scores — by 0.150 points for Albuterol HFA and 0.220 points for Combivent CFC. On an asthma symptom control questionnaire (scored 0–6, where lower means fewer symptoms), both groups reported the same average change of -0.25 points. The number of puffs of medication used during the day decreased by an average of 0.49 puffs for Albuterol HFA and 0.53 puffs for Combivent CFC; at night, the decreases were 0.10 and 0.12 puffs respectively. No outcome data was reported for the Placebo Respimat or Combivent Respimat groups in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00245570 · results posted 27 May 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 47 adults across six groups, each receiving the same three treatments — montelukast (a tablet), salmeterol (an inhaled medicine), and a placebo (a dummy treatment with no active ingredient) — but in a different order. The washout periods between treatments were designed to clear each medicine from the body before the next one began. The trial was measuring how much a person's lung function dropped after an exercise test, specifically looking at a breathing measurement called FEV1 (the amount of air a person can forcefully breathe out in one second). A larger percentage fall in FEV1 after exercise indicates a greater degree of airway narrowing triggered by exercise. The reported data shows that for the main outcome — the maximum percentage fall in FEV1 measured two hours after taking the study medicine — the placebo group had an average fall of about 21.9%, while the montelukast group had an average fall of about 13.2%, and the salmeterol group had an average fall of about 10.5%. At 8.5 hours after the dose, the reported figures were approximately 11.6% for montelukast, 11.0% for salmeterol, and 16.7% for placebo. At 24 hours after the dose, the reported figures were approximately 10.1% for montelukast, 16.2% for salmeterol, and 13.6% for placebo. The reported data also shows that fewer participants needed a "rescue" inhaler (a fast-acting reliever medicine) after the exercise test in the montelukast and salmeterol periods compared with the placebo period at the two-hour and 8.5-hour time points, though the numbers were more similar across all three groups at 24 hours. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00306163 · results posted 26 April 2010

  According to the results reported on ClinicalTrials.gov, this trial involved 37 adults — 19 in the ciclesonide group and 18 in the fluticasone group — and all participants completed the study with no dropouts. The trial was comparing two inhaled medicines (ciclesonide and fluticasone) delivered in two different particle sizes — one very small (around 1 micron) and one much larger (around 10 microns). The main thing being measured was how the lungs' sensitivity to a substance called AMP changed after treatment compared to before treatment. AMP is used in a breathing test where increasing amounts are inhaled until lung function drops by 20%; a higher amount needed to trigger that drop suggests the airways were less reactive. The reported data shows the main outcome was expressed as a logarithm (a mathematical scale used to compress a wide range of numbers) of the concentration of AMP needed to trigger that 20% drop in lung function. For the small-particle versions, the ciclesonide group had a reported mean change of 4.9 and the fluticasone group 5.2. For the large-particle versions, the ciclesonide group recorded 3.7 and the fluticasone group 3.0. Two further sets of figures — 6.6 (ciclesonide) and 6.0 (fluticasone), and 4.5 (ciclesonide) and 4.3 (fluticasone) — were also listed, though the data as submitted does not clearly label which specific sub-conditions these correspond to. The reported data shows that the two secondary outcomes — a measure of lung volume changes during the AMP test, and an assessment of safety and tolerability — had no numerical results submitted to ClinicalTrials.gov, so those figures are not available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00739297 · results posted 9 April 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 68 participants in total. It tested five different inhaled doses of a medicine called montelukast (25, 100, 250, 500, and 1,000 micrograms) against a placebo (a dummy treatment with no active ingredient) in people with asthma. The trial used a "crossover" design, meaning participants took different treatments across multiple rounds, with short washout periods in between. The main thing being measured was how much a person's lung function — specifically a breathing test called FEV1 (which measures how much air someone can breathe out forcefully in one second) — changed over the four hours after taking each treatment. The reported data shows that for the primary outcome — the average change in FEV1 over four hours — the placebo group showed an increase of 0.03 litres from their starting level. The montelukast groups showed increases of 0.07 litres (25 mcg), 0.13 litres (100 mcg), 0.10 litres (250 mcg), 0.09 litres (500 mcg), and 0.12 litres (1,000 mcg). For the secondary outcome, which looked at lung function over 90 minutes after participants were also given a standard reliever puffer (albuterol, known in Australia as salbutamol), the reported data shows an average change of 0.34 litres when montelukast was combined with albuterol, compared with 0.15 litres when montelukast was combined with a placebo puffer. Additional measurements at 8 and 24 hours after montelukast were also recorded, with changes ranging from 0.06 to 0.14 litres at 8 hours and 0.02 to 0.10 litres at 24 hours across the different groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00583947 · results posted 8 February 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 53 people in total — 27 in one group and 26 in another. It was a crossover study, meaning participants tried more than one treatment in sequence, with a washout period in between. The trial was comparing two inhaled breathing medicines — arformoterol (at two different doses: 7.5 micrograms and 15 micrograms) and levalbuterol (0.63 mg) — delivered by a nebuliser (a device that turns liquid medicine into a fine mist). The main things being measured were heart rate and blood pressure, and a secondary measurement was lung function (specifically how much air a person could forcibly breathe out in one second, known as FEV1). The reported data shows that before any doses were given, average heart rates across the three treatment groups were similar, ranging from around 84 to 88 beats per minute. After three cumulative doses, the reported average heart rate rose to about 96 beats per minute in the levalbuterol group, 89 beats per minute in the arformoterol 7.5 mcg group, and 94 beats per minute in the arformoterol 15 mcg group. In terms of the change from before dosing, the largest reported increase in heart rate was 8.7 beats per minute in the levalbuterol group at one timepoint, compared to 4.4 and 6.5 beats per minute in the two arformoterol groups at the same point. For blood pressure, the reported changes from before dosing were relatively small across all groups throughout the measurements. For lung function, the reported FEV1 figures (the amount of air breathed out in one second) started at around 1.49–1.55 litres before dosing and rose to approximately 1.66–1.74 litres after dosing across all three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00832455 · results posted 5 February 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 445 participants taking montelukast (a medicine used for asthma control). Of those, 420 reached the baseline starting point, and 373 completed the full 12-week study. The trial was measuring asthma symptom control using a questionnaire called the Asthma Control Questionnaire (ACQ), where people answer seven questions about how often and how badly asthma affects them. Scores run from 0 (well controlled) to 6 (very poorly controlled), with a score of 0.75 or below considered well controlled. The reported data shows that at the start of the study, 328 out of 419 participants had ACQ scores suggesting their asthma was not well controlled (above 0.75), while 91 were already in the well-controlled range. By week 4, those numbers shifted — 159 participants were in the not-well-controlled group and 251 had moved into the well-controlled range. By week 12, 96 participants were in the not-well-controlled group and 276 were in the well-controlled range. For the secondary measure using the same questionnaire, a similar pattern in participant numbers across the categories was reported at each time point. The trial also looked at how satisfied doctors and patients were with the asthma medication at various time points, and for caregivers of child patients, a quality-of-life score (on a scale of 1–7) was reported as changing by approximately 1.06 points at week 4, 1.39 at week 8, and 1.36 at week 12 from the starting point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00448435 · results posted 11 August 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 51 children in total (26 in one group and 25 in the other). It compared two asthma inhaler treatments: a combination inhaler called SFC (which contained two medicines in a single device) versus the same two medicines taken separately (SLM + FP). The trial used a "crossover" design, meaning each child tried both treatments in turn, with a two-week break in between. The main thing being measured was how much a child's morning peak expiratory flow — a simple breath test that measures how fast air can be blown out of the lungs — changed compared to where it started. The reported data shows that, for the primary measure (morning breath-test speed), children on the combination inhaler showed an average increase of about 14.3 litres per minute from their starting point, while children on the separate medicines showed an average increase of about 17.1 litres per minute. For the secondary measures, the reported data shows similar patterns: the percentage of predicted normal breath-test speed rose by around 5.4% for the combination inhaler group and 6.7% for the separate medicines group; the percentage of each child's personal-best breath-test speed rose by about 5.0% and 6.5% respectively. Evening breath-test readings increased by approximately 16.3 and 15.8 litres per minute for the two groups. The day-to-night variation in breath-test scores changed by very small amounts (0.06% and −0.08%). Regarding symptom-free nights, approximately 72.9% of children on the combination inhaler and 81.3% on separate medicines were reported to have symptom-free nights; for symptom-free days, the reported figures were approximately 91.7% and 81.3% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00200967 · results posted 2 June 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 87 people with asthma — 42 in a group carrying a genetic variation called "Arg/Arg" at a specific gene position (B16), and 45 in a group carrying a different variation called "Gly/Gly." The trial was looking at whether these two genetic groups responded differently when switching between an active asthma preventer medicine (salmeterol) and a dummy (placebo) version of the same medicine. Participants went through two treatment periods with a wash-out break in between, and by the end, 34 Arg/Arg participants and 41 Gly/Gly participants had completed all stages. The reported data shows that the main thing being measured was morning peak expiratory flow (PEF) — a simple breath test where you blow as hard and fast as you can into a small device, giving a number in litres per minute. The reported figures show a change of −21 litres per minute for the Arg/Arg group and −22 litres per minute for the Gly/Gly group when comparing active medicine to placebo. For the evening PEF, the reported changes were −25 and −24 litres per minute respectively. For a lung function test called FEV1 (how much air you can force out in one second), the reported changes were −0.08 litres and −0.04 litres. The reported data also shows very small differences between the two groups for symptom scores (0.04 versus 0.00 on a 0–3 scale), rescue inhaler use (0.2 versus 0.0 puffs per day), and PEF variability (0.2% versus 0.7%). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.