Reported trial results for COPD

Every COPD trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

140 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

NCT03658538 · results posted 24 September 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03658538) involved people with COPD (a lung condition). A total of 59 people were assigned to the active treatment group and 61 to the control group (who did not receive the active treatment). Of those, 48 and 51 people respectively completed the trial. The trial was measuring changes in quality of life, breathlessness, general COPD health status, lung function, and how often participants needed healthcare due to COPD flare-ups — all tracked over a six-month follow-up period. The reported data shows the following changes in scores from the start of the trial to the end. For quality of life (measured on a scale of 0–100, where higher means more limitations), the active treatment group's score changed by −2.9 points and the control group's by +1.5 points. For breathlessness (measured on a scale of 0–120, where higher means more difficulty breathing), the active treatment group changed by −4.8 points and the control group by +1.3 points. For overall COPD health status (scale 0–40, higher meaning worse), the active treatment group changed by −1.8 and the control group by +1.0. For a separate breathlessness measure (scale 0–4), the active treatment group changed by −0.3 and the control group by +0.1. Regarding lung function — specifically the proportion of air a person can forcefully breathe out in one second compared to what is expected for someone of their age and size — the active treatment group changed by −1.2% predicted and the control group by −0.8% predicted. For healthcare use due to COPD flare-ups, the reported data shows two sets of figures across the follow-up period; the active treatment group recorded proportions of 0.11 and 0.07, while the control group recorded 0.09 and 0.19 — however, the data as submitted does not clearly label which time points these figures correspond 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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NCT04765722 · results posted 16 September 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04765722) enrolled 30 people in total — 15 in a group receiving a medicine called mepolizumab and 15 in a group receiving a placebo (an inactive dummy treatment). All 15 people in the mepolizumab group completed the trial, while 14 of the 15 in the placebo group did so. The trial was measuring cough frequency — how many times per hour participants coughed, recorded by a monitoring device — as well as cough severity, to see how these figures changed over 14 weeks. The reported data shows the following numbers. For the main (primary) outcome — coughs per hour over a 24-hour period at 14 weeks — the mepolizumab group started at an average of 17.0 coughs per hour and was recorded at 12.6 coughs per hour at 14 weeks. The placebo group also started at 17.0 coughs per hour and was recorded at 10.6 coughs per hour at 14 weeks. For coughing during waking hours at 14 weeks, both groups started at 22.5 coughs per hour; the mepolizumab group was recorded at 16.3 and the placebo group at 14.1. For coughing during sleep at 14 weeks, both groups started similarly (around 1.7–1.8 coughs per hour); the mepolizumab group was recorded at 1.9 and the placebo group at 1.5. For cough severity at 8 weeks — measured on a scale of 0 (no cough) to 100 (worst possible cough) — the mepolizumab group went from 65.3 to 55.7, and the placebo group went from 63.9 to 49.3. Cough severity figures at 14 weeks were not reported in the data. It is worth noting that the trial was very small, with only around 15 people per group, and the reported data shows numbers for both groups at the start and at follow-up time points, but does not include a direct comparison figure 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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NCT05349123 · results posted 6 June 2025

According to the results reported on ClinicalTrials.gov, this trial involved 99 people split into two groups — 48 in the intervention group and 51 in the control group. All 99 participants completed the study with no dropouts reported. The trial was measuring breathlessness, emotional wellbeing, and physical activity levels in people with a chronic respiratory (lung) condition, using two tools: a questionnaire called the Chronic Respiratory Disease Questionnaire (which asks people to rate their symptoms on a 1–7 scale, where higher scores mean less impact from symptoms), and a wearable activity monitor to count daily steps. The reported data shows that for breathlessness, the intervention group's score changed by 0.68 points at one time point and 0.34 at another, while the control group's score changed by 0.71 and 0.83 respectively. For the questionnaire's emotional wellbeing section, the intervention group's scores changed by 0.45 and then 0.35, while the control group's changed by 0.55 and 0.50. The trial notes that a change of 0.5 points or more on this scale is considered a "minimally important difference" — meaning a change noticeable enough to matter to a patient. For physical activity, the reported data shows the intervention group's average daily step count changed by +765.98 steps at one time point and −181.78 at another, while the control group's changed by +701.50 and +290.36 steps respectively. It is worth noting that the data as submitted does not clearly label which measurements correspond to which time points, so the figures above are presented in the order they appear in the reported 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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NCT05305989 · results posted 2 May 2025

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called belumosudil in people with chronic graft-versus-host disease (cGVHD) — a condition that can occur after a stem cell transplant when donor immune cells attack the recipient's body. A total of 23 people took part, split across three groups based on the dose they received: 13 people received 200 mg once a day, 9 people received 200 mg twice a day, and 1 person received 400 mg once a day. The trial measured several things, including how long any improvement in cGVHD signs lasted, changes in self-reported symptom burden using a questionnaire called the Lee Symptom Scale (LSS), how long before participants needed a new treatment, and overall survival. The reported data shows mixed results across the outcome measures. For the LSS symptom questionnaire — which scores symptoms from 0 to 100, where a higher score means more bothersome symptoms — a reduction of 7 or more points was considered a meaningful change. In the 200 mg once-a-day group, 8 out of 13 participants recorded at least a 7-point reduction at some point, and 8 also showed that reduction across two check-ups in a row. In the 200 mg twice-a-day group, 2 out of 9 showed the single-timepoint reduction, and 1 out of 9 showed it at two consecutive check-ups. In the 400 mg once-a-day group (just 1 person), no such reduction was recorded. Among those who did show a sustained symptom reduction, the average duration of that reduction was reported as approximately 67 weeks in the once-daily group and approximately 50 weeks in the twice-daily group. For several other measures — including how long clinical response lasted, time to needing a new treatment, failure-free survival, and overall survival — the data was not reported as a calculable number 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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NCT04456673 · results posted 17 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04456673) enrolled 935 people with chronic obstructive pulmonary disease (COPD) — 465 in the placebo group and 470 in the dupilumab 300 mg group. The trial ran for 52 weeks and was primarily measuring how often participants had moderate or severe COPD flare-ups (called exacerbations — episodes where symptoms worsen significantly, sometimes requiring hospital care or extra medicines). Secondary measurements included changes in lung airflow, and how participants rated their own breathing-related quality of life using a standard questionnaire called the Saint George's Respiratory Questionnaire (SGRQ), where a lower score means better quality of life. The reported data shows that, for the main outcome, the placebo group had an average of 1.295 flare-ups per person per year, while the dupilumab group had an average of 0.859 flare-ups per person per year. For lung airflow (measured by how much air someone can forcefully breathe out in one second, known as FEV1), the placebo group showed an average increase of 0.057 litres by week 12 and 0.054 litres by week 52 from their starting point, while the dupilumab group showed an average increase of 0.139 litres by week 12 and 0.115 litres by week 52. For the quality-of-life questionnaire at week 52, scores in both groups improved from their starting points — the placebo group's score dropped by an average of 6.4 points and the dupilumab group's score dropped by an average of 9.8 points (a bigger drop meaning a bigger reported improvement). Around 46.5% of placebo participants and 51.4% of dupilumab participants showed an improvement of at least 4 points on that questionnaire by week 52, which is considered a meaningful change on this 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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NCT03655028 · results posted 17 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03655028) involved 93 people in total — 46 in a music-based walking group (called the RAS-music group, where participants walked in time with specially designed music) and 47 in a control group. All participants started the trial, but by the 12-week check-in, 10 people from the music group and 7 from the control group had dropped out, with similar small numbers leaving before the final 24-week check-in. The trial was measuring how far people could walk in six minutes, how active they were day-to-day, their quality of life, and how well they stuck to the walking programme. The reported data shows that at the main 12-week measurement point, the music group walked an average of 452 metres in six minutes, compared to 429 metres in the control group. At 24 weeks, the reported figures were 444 metres for the music group and 439 metres for the control group. For daily activity, the music group recorded an average of around 3,930 steps per day, compared to roughly 3,738 steps per day in the control group. Quality of life scores (on a scale of 0–100 where higher is better) were reported as 40.4 versus 38.7 for physical function, and 42.8 versus 42.3 for mental health, between the music and control groups respectively. The reported data also shows that participants in the music group completed an average of about 25.6 walking sessions, compared to 19.7 sessions in the control group. These figures describe how many exercise sessions each group finished during the programme. 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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NCT02386722 · results posted 4 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT02386722) enrolled 165 people with asthma or COPD (a lung condition causing breathing difficulties) — 84 in the intervention group and 81 in the control group. The trial ran for up to 182 days (roughly six months) and was measuring things like how long it took before a person had a flare-up (called an "exacerbation," meaning a sudden worsening that required medical attention), how many flare-ups occurred overall, how many were serious enough to need hospitalisation, and how consistently participants used their inhalers as prescribed. The reported data shows that, on average, participants in the intervention group had their first flare-up after 172 days, compared with 161 days in the control group. For the average number of flare-ups per person during the study, the intervention group recorded 0.3 and the control group recorded 0.5. The number of serious flare-ups requiring hospitalisation was reported as 0.08 per person in both groups. Regarding inhaler use, the reported data shows the intervention group used their puff inhalers within the recommended range for an average of 81.6 days, compared with 60.1 days in the control group. For dry powder capsule inhalers, the intervention group was in the target range on 89.6% of days versus 80.2% for the control group. A separate measure of puff inhaler use showed 68.9% of days in range for the intervention group and 50.6% for 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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NCT03604692 · results posted 27 November 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03604692) enrolled 41 people in total across two phases. The first phase tested different doses of a drug called SNDX-6352 in small groups of patients to find a safe starting dose for a larger study — this is a standard first step when testing a new medicine. The second phase then enrolled 23 participants at the chosen dose to measure how often patients responded to the treatment. All participants had chronic graft versus host disease (cGVHD), a condition that can occur after a bone marrow or stem cell transplant. The reported data shows that in the first phase, out of the 17 participants assessed across all dose groups, 2 participants (both in the 3 mg/kg every-two-weeks group) experienced what are called "dose-limiting toxicities" — meaning side effects serious enough within the first treatment period to be flagged under the trial's rules. No dose-limiting toxicities were reported in the other dose groups. Based on the first phase findings, the trial team selected 1 mg/kg given every two weeks as the dose to carry forward into the second phase. In the second phase, the reported data shows that 39.1% of the 23 participants (roughly 9 out of 23) had either a complete response (all signs of the condition resolved) or a partial response (improvement in at least one area without worsening elsewhere) at around the six-month mark. The trial also measured how the drug moved through the body at different doses; the reported figures show that higher doses were associated with higher drug levels in the blood, though the detailed breakdown of those numbers was not fully consistent across all reported data entries. 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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NCT04710576 · results posted 10 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04710576) looked at a medicine called axatilimab in people with chronic graft-versus-host disease (cGVHD) — a condition that can occur after a bone marrow or stem cell transplant, where the donated cells attack the recipient's body. A total of 241 people took part, split across three groups that each received a different dose or dosing schedule of axatilimab. The trial's main goal was to measure how many participants showed a meaningful improvement in their cGVHD symptoms within the first six treatment cycles, based on a recognised set of medical criteria. The reported data shows that in the group receiving the lowest dose (0.3 mg/kg every two weeks), 73.8% of participants were recorded as having a response — meaning their condition either fully resolved or partially improved without getting worse elsewhere. In the group receiving the middle dose (1 mg/kg every two weeks), the reported response rate was 66.7%. In the group receiving the highest dose given less frequently (3 mg/kg every four weeks), the reported response rate was 50.0%. It is worth noting that very few participants formally "completed" the study as defined in the trial records (0–1 per group), and the reported data for all secondary outcome measures — including how long responses lasted, symptom relief, and organ-specific responses — 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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NCT03959982 · results posted 19 September 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03959982) enrolled 11 people in total — 8 in the HHHFA (heated humidified high-flow air) randomised group and 3 in the control group. The trial was measuring sleep quality, walking distance, and health-related quality of life in people with COPD (a lung condition), comparing those who received the HHHFA therapy against those who did not. Of the 11 who started, 7 completed the study — 4 from the HHHFA group and all 3 from the control group. The reported data shows the following changes over the 6-week study period. For sleep quality (measured using a questionnaire scored 0–21, where higher numbers mean worse sleep), the HHHFA group's score changed by −0.5 (a very small improvement) and the control group's score changed by +1 (a small worsening). For the 6-minute walk test (how far someone can walk in 6 minutes, where more metres is better), the HHHFA group's distance changed by +20 metres and the control group's by +1.5 metres. For health-related quality of life (measured using a questionnaire scored 0–40, where higher numbers mean worse quality of life due to COPD), the HHHFA group's score showed no change (0), while the control group's score changed by −7 (an improvement). It is worth noting that this was a very small trial, and four participants in the HHHFA group did not complete it — the reasons for this were not reported 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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NCT01742338 · results posted 10 April 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT01742338) enrolled 89 people who had been hospitalised with a flare-up of COPD (chronic obstructive pulmonary disease). Participants were split into two groups: 47 received a lower dose of corticosteroids (a type of anti-inflammatory medicine) and 42 received a higher dose. The trial was measuring whether the dose of corticosteroids made a difference to a range of outcomes over 30 days, including death, needing a breathing machine, being re-admitted to hospital for COPD, or needing extra treatment. The reported data shows that the main outcome — called "treatment failure," meaning any one of those serious events occurred within 30 days — was recorded in 14 out of 47 people in the low-dose group and 10 out of 42 people in the high-dose group. For the secondary outcomes, the reported data shows that both groups had a median hospital stay of 2 days, and both groups scored 1.8 out of 6 on a quality-of-life questionnaire (where 0 represents the best score and 6 the worst). For the pre-specified outcome measuring side effects such as high blood sugar, high blood pressure, or infections requiring extra treatment, the reported data shows that no figures were provided — this data was not reported 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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NCT05241288 · results posted 23 January 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 54 people who used a smart inhaler called the ProAir® Digihaler® (which contains a reliever medicine called albuterol) over three months. The inhaler has built-in sensors that automatically record how a person breathes in when they use it. The trial was measuring how much a person's peak inspiratory flow — the fastest speed at which they inhale — varied from use to use over time, and also looked at things like how much air people breathed in with each puff and whether people's own memory of how often they used the inhaler matched what the device actually recorded. Of the 54 people who started, 40 completed the study, and 14 did not complete it (the reasons were not detailed in the reported data). The reported data shows that the average peak inspiratory flow across participants was 67.6 litres per minute. The variability in that flow — measured using something called a coefficient of variation (a number that shows how spread out the readings were relative to the average, where a higher number means more variability) — was reported as 0.286. For inhalation volume, the average amount of air breathed in per puff was reported as 1.395 litres, with a coefficient of variation of 0.426, suggesting the volume varied somewhat more from puff to puff than the flow speed did. On the secondary measure comparing what people remembered about their inhaler use versus what the device actually recorded, the reported correlation coefficient was −0.385, meaning there was a weak inverse relationship between the two — though the practical meaning of this figure was not further 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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NCT03085485 · results posted 21 December 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people in total — 30 received ivacaftor and 10 received a placebo (an inactive look-alike treatment). Of those, 28 in the ivacaftor group and all 10 in the placebo group completed the study. The trial was primarily measuring a number of safety-related things in people taking ivacaftor, and also looked at two secondary measures related to how a protein called CFTR was functioning in the body — one measured in the lungs (mucociliary clearance, which is how well the lungs clear mucus) and one measured through a sweat test. The reported data shows that when it came to adverse events (unwanted health events recorded during the trial), 19 out of 30 people in the ivacaftor group and 6 out of 10 in the placebo group experienced at least one adverse event. Of those, 7 in the ivacaftor group and 3 in the placebo group experienced a serious adverse event. One person in each group had an abnormal heart tracing (ECG) result. No abnormal blood chemistry or blood count results were recorded in either group. For the lung mucus clearance measure, the reported data shows the ivacaftor group cleared approximately 88.4% at one point and 86% at another, compared to 86.2% and 80% in the placebo group. For the sweat test, the reported change was 3.9 mmol/L in the ivacaftor group and 3.8 mmol/L in the placebo group — a unit that reflects the concentration of salt in sweat. 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 ↗
NCT04072887 · results posted 28 April 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04072887) enrolled 974 people in total across six groups. Participants received one of five different doses of a drug called QBW251 (25 mg, 75 mg, 150 mg, 300 mg, or 450 mg) or a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in lung function and respiratory symptoms in people with a chronic lung condition, over a period of up to 24 weeks. The main thing the trial was set up to measure was a lung function test called FEV1 — essentially how much air a person can forcibly breathe out in one second — at 12 weeks. The reported data shows that at 12 weeks, all groups — including the placebo group — showed only very small changes in FEV1 from where they started. The placebo group's average change was 0.001 litres, while the QBW251 groups ranged from 0.006 litres (25 mg dose) up to 0.021 litres (75 mg dose). The reported data also shows changes on symptom questionnaires (measuring things like cough, mucus, and general respiratory symptoms) across several time points, with all groups — including placebo — showing small reductions in symptom scores over time. The numbers reported for these questionnaire scores were broadly similar across the QBW251 doses and the placebo group. Information on some questionnaire sub-groups at certain time points was not fully 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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NCT02013427 · results posted 3 March 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02013427) involved 82 people across three groups: 25 in an observational group (no treatment, just monitored), 5 who received a combination of naproxen and omeprazole (a pain-relief medicine and a stomach-protecting medicine), and 52 who received a placebo (a dummy treatment with no active ingredients). Not everyone finished the study — 20, 4, and 43 people completed it in each group respectively. The trial was measuring changes in self-reported pain levels over 6 weeks, using a scale from 0 (no pain) to 10 (worst imaginable pain). The reported data shows pain levels were compared before and after the 6-week period, and the results are expressed as a percentage change — a negative number meaning pain scores went down, and a positive number meaning they went up. According to the results reported on ClinicalTrials.gov, the observational group showed a 3% reduction in pain scores (−0.03), the naproxen and omeprazole group showed a 10% reduction (−0.10), and the placebo-only group showed a 21% reduction (−0.21). No other outcome measures were reported in the submitted data. It is worth noting that the placebo group was much larger than the other groups, and no further breakdown or additional outcome data was included in the submission. The reported data shows only these percentage-change figures — what they mean in a broader clinical sense was not 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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NCT03546907 · results posted 22 November 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03546907) enrolled 343 people with chronic obstructive pulmonary disease (COPD) — 171 received a placebo (a dummy treatment with no active ingredient) and 172 received the investigational medicine SAR440340. The trial was primarily measuring how often participants experienced moderate or severe flare-ups of their COPD (called exacerbations) over the course of the study. Secondary measurements included changes in lung function, specifically how much air a person could forcefully breathe out in one second (a standard lung function test), and how long it took before a participant had their first flare-up. The reported data shows that participants in the placebo group experienced an average of 1.61 flare-ups per year, while those in the SAR440340 group experienced an average of 1.30 flare-ups per year. For lung function before using a puffer (bronchodilator), the placebo group showed no average change from the start of the trial, while the SAR440340 group showed an average increase of 0.06 litres. After using a puffer, the placebo group showed an average change of 0.01 litres and the SAR440340 group showed 0.04 litres. Regarding the time to a first flare-up, the reported data shows a median (the midpoint value across all participants) of 199 days in the placebo group and 277 days in the SAR440340 group. It is worth noting that 17 people in the placebo group and 21 in the SAR440340 group did not complete the trial, though the reasons were 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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NCT02867761 · results posted 30 August 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 535 people in total — 261 received a combination inhaler containing two medicines called indacaterol and glycopyrrolate, and 274 received a placebo (an inactive, dummy treatment). The trial ran for 12 weeks and was designed to measure whether people's breathing-related quality of life improved, using several standardised questionnaires. These questionnaires ask people to rate how much their breathing symptoms affect their day-to-day life, with lower scores meaning fewer symptoms. The trial also tracked "treatment failure," meaning whether someone's symptoms got bad enough that they needed additional medicines during the study period. The reported data shows that for the main outcome — the number of people who scored at least 4 points better on the St. George's Respiratory Questionnaire (a commonly used breathing symptoms survey) and did not need extra treatment during the 12 weeks — 128 people in the indacaterol/glycopyrrolate group and 144 people in the placebo group met this measure. For the secondary outcomes, the reported data shows that 169 people in the active treatment group and 166 in the placebo group showed a meaningful improvement on a second symptom survey (the CAT); 80 people in each group showed a meaningful improvement on a breathlessness scale (BDI/TDI); and 55 versus 60 people showed meaningful improvement on both the breathing quality survey and the breathlessness scale combined. On average, both groups showed a reduction (improvement) in their questionnaire scores over the 12 weeks — the active treatment group's St. George's score fell by 7.7 points on average, compared with 8.9 points in the placebo group; and the CAT score fell by 4.5 points in the active group versus 4.8 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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NCT03112603 · results posted 15 April 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 329 people in total — 165 received ruxolitinib and 164 received what the trial called "best available therapy" (the best standard treatment the doctor could offer). A further 70 people who had been in the standard-treatment group later crossed over to receive ruxolitinib in a separate phase of the trial. The trial was measuring responses in people with a condition called chronic graft-versus-host disease that had stopped responding to steroids — a complication that can occur after a bone marrow or stem cell transplant. The main thing being measured was how many participants showed a meaningful improvement in their condition by a set point in time (around six months into treatment). The reported data shows that, at the main measurement point, approximately 49.7% of participants in the ruxolitinib group showed a response (meaning their disease showed signs of improvement), compared with 25.6% in the standard-treatment group. When looking at the best response recorded at any point up to that same time, the figures were 76.4% and 60.4% respectively. Among those who crossed over to ruxolitinib, the reported best response rate was 81.4%. For a measure called "failure-free survival" — roughly, the time until the disease worsened, came back, death occurred, or a new treatment had to be added — the reported data shows 38.4 months for the ruxolitinib group and 5.7 months for the standard-treatment group, though the data notes for the ruxolitinib group's initial figure were marked as not available at the earlier cut-off. Regarding self-reported symptom improvement, 24.2% of the ruxolitinib group and 11.0% of the standard-treatment group were reported to have shown a meaningful reduction in symptoms on a standardised questionnaire. 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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NCT04011475 · results posted 11 March 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT04011475) looked at people with a chronic lung condition (likely COPD) who were taking one of three different inhaled medication combinations. A total of 1,617 people were enrolled across three groups: 239 people took a combination called tiotropium and olodaterol (Group A), 937 people took a different two-medicine combination from the same drug classes (Group B), and 441 people took a single medicine from one of those classes (Group C). The trial was observational — meaning researchers watched what happened to people already on these medicines rather than randomly assigning them — and the main thing being measured was how many people had a moderate-to-severe worsening of their lung condition (called an "exacerbation") within one year. The reported data shows that, for the primary outcome, 20 out of 114 matched participants in Group A, 22 out of 114 in Group B, and 9 out of 114 in Group C experienced a moderate-to-severe worsening episode within the year. (Note: the matching process reduced each group to 114 people to make fairer comparisons.) For the secondary outcomes, the reported average number of moderate-to-severe worsening episodes per person per year was 0.28 for Group A, 0.42 for Group B, and 0.10 for Group C. Mild worsening episodes per person per year were reported as 0.00, 0.04, and 0.04 respectively. The reported data also shows that 10 people in Group A, 17 in Group B, and 19 in Group C moved on to a more intensive medication regimen during the year. 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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NCT04249310 · results posted 30 August 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT04249310) looked at two groups of people with chronic obstructive pulmonary disease (COPD) — a lung condition — who were taking one of two inhaled breathing medicines: a combination medicine called Tiotropium/Olodaterol (Spiolto®), or Tiotropium alone (Spiriva®). In total, 1,436 people were in the Spiolto® group and 5,352 in the Spiriva® group at the start. To make a fairer comparison between the two groups, the researchers used a statistical matching process that paired similar patients together, resulting in 1,412 matched pairs (or 1,302 pairs under a slightly different matching method). The trial was measuring how long it took before patients moved on to a more complex three-drug ("triple therapy") regimen, as well as how often and how quickly patients experienced worsening of their COPD symptoms (called "flare-ups" or exacerbations). The reported data shows that, for the main outcome — time until starting triple therapy — the Spiolto® group reached a median of 195 days, compared with 89.5 days in the Spiriva® group. (Median here simply means the middle value: half the patients in each group reached that point before the number shown, and half after.) For the secondary outcome of time to a first moderate or severe COPD flare-up, the reported figures across different analyses ranged from approximately 116 to 134 days for the Spiolto® group and approximately 119 to 139 days for the Spiriva® group. The reported data shows that the average number of moderate or severe flare-ups per person was 0.08 for both groups in one analysis, and 0.04–0.05 in the other two analyses, with very similar figures between the two medicines across all comparisons. 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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NCT02261727 · results posted 12 August 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,670 people across three groups: one group received low-dose theophylline (a type of medication), one received a combination of theophylline and prednisone (a steroid), and one received a placebo (a dummy treatment with no active ingredient). All participants had COPD (a lung condition) and were followed for 48 weeks. The trial was primarily measuring how often participants had COPD flare-ups (called exacerbations) during that time. Not everyone finished the study — around 411–423 people per group completed it out of the 548–568 who started. The reported data shows that the placebo group had, on average, 1.00 flare-ups per person per year, compared to 0.86 in the low-dose theophylline group and 0.89 in the theophylline-and-prednisone group. For the secondary measures, the reported data shows that the median time (the midpoint — half of participants took longer, half took less time) before a first flare-up was 137 days in the placebo group, 150 days in the low-dose theophylline group, and 151 days in the combination group. On a quality-of-life questionnaire (where lower scores mean fewer limitations), all three groups showed a reduction in score from their starting point: −4.95 for placebo, −6.85 for low-dose theophylline, and −6.48 for the combination group. A separate symptom questionnaire (scored 0–40, with lower being better) also showed reductions from baseline in all groups: −2.29 for placebo, −2.77 for low-dose theophylline, and −2.57 for the combination. A breathing measurement (FEV1) changed only marginally in all three groups. The reported number of hospital admissions over 48 weeks was 120 in the placebo group, 101 in the low-dose theophylline group, and 122 in the 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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NCT04107493 · results posted 26 May 2021

According to the results reported on ClinicalTrials.gov, this trial involved 33 people in total, split into two groups of 16 and 17. It used a "crossover" design, meaning each participant tried both devices — a standard portable oxygen cylinder and a device called the Mobi™ Portable Oxygen Concentrator — in a different order, with a rest period in between. The trial was measuring blood oxygen levels (the amount of oxygen being carried in the blood, recorded as a percentage) while participants completed a six-minute walking test using each device. The reported data shows that during the six-minute walk test, the average blood oxygen level recorded for participants while using the portable oxygen cylinder was 91.2%, and while using the Mobi™ Portable Oxygen Concentrator it was 90.0%. No other outcome measures appear to have been submitted to ClinicalTrials.gov, so no further figures are available to report 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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NCT02959944 · results posted 4 May 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 193 people — 95 in the ibrutinib plus prednisone group and 98 in the placebo plus prednisone group. All participants had chronic graft-versus-host disease (cGVHD), a condition that can occur after a stem cell or bone marrow transplant where the donor cells attack the recipient's body. The trial was measuring whether adding ibrutinib (a tablet medicine) to the steroid prednisone made a difference compared to adding a dummy pill (placebo) to prednisone. The main thing being measured was the proportion of participants whose condition showed a clear improvement — either complete clearing or meaningful reduction of symptoms — at 48 weeks. The reported data shows that at the 48-week mark, 41.1% of participants in the ibrutinib plus prednisone group met the criteria for a response (complete or partial improvement), compared with 36.7% in the placebo plus prednisone group. These figures were the same in both the primary (earlier) and final analyses. For the secondary measures — tracking how many participants were eventually able to stop taking corticosteroids (steroid medicines) altogether — the reported data shows the proportions in both groups were broadly similar across the follow-up period. By the final analysis, roughly 45% of the ibrutinib group and 37% of the placebo group had stopped all corticosteroids. For stopping all immune-suppressing medicines combined, around 35% of the ibrutinib group and 29% of the placebo group had done so by the end of the final follow-up 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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NCT04155047 · results posted 8 April 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT04155047) involved 22 participants in total — 11 in each group. It used a "crossover" design, meaning participants tried both treatments at different times: one group received a Glycopyrrolate Inhalation Solution (GIS) first and then a placebo (an inactive, dummy inhaler), while the other group received the placebo first and then GIS. The trial was measuring changes in something called **Residual Volume (RV)** — this is the amount of air left in the lungs after a person breathes out as fully as they can. A higher residual volume can be a sign of air becoming trapped in the lungs. Of the 22 who started, 20 completed the study (2 participants in the first group did not finish; no reason was reported in the data). The reported data shows that the primary outcome — change in residual lung air volume measured 6 hours after taking the treatment — was as follows: participants who received the **placebo** showed an average change of **+0.004 litres** (essentially no change from their starting measurement), while participants who received the **GIS 25 mcg single dose** showed an average change of **−0.319 litres** (a reduction from their starting measurement). No secondary outcome measure 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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NCT03137992 · results posted 5 April 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03137992) enrolled 374 participants in total across six groups. Each group received three different inhaled treatments in a different order — a test version of tiotropium bromide powder (made by Lupin), the brand-name version called Spiriva®, and a placebo (an inactive dummy inhaler) — with rest periods in between. The trial was measuring how much air participants could breathe out in one second over a 24-hour period after a single dose, a measurement known as FEV1 (forced expiratory volume in one second). The goal was to compare the test product and Spiriva® against each other, and both against the placebo. A smaller number of participants also continued into an optional open-label extension phase. The reported data shows the following numbers for the primary measurement (the total "area" of breathing improvement over 24 hours, expressed in litres multiplied by hours): the test product group recorded a value of approximately 2.56 L·hour, and the Spiriva® group recorded approximately 2.74 L·hour. When each active treatment was compared against the placebo, the reported figures were roughly 2.90 L·hour for the test product, 3.03 L·hour for Spiriva®, and −0.40 L·hour for the placebo group — meaning the placebo group's average breathing measurement was slightly below their starting point over that 24-hour window. 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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NCT03611777 · results posted 17 February 2021

According to the results reported on ClinicalTrials.gov, this study enrolled 901 people with COPD (chronic obstructive pulmonary disease, a lung condition that makes breathing difficult). Of these, 432 were taking inhaled corticosteroids (a type of inhaled preventer medicine, often called ICS) at the time of their study visit, and 469 were not. The study was observational — meaning researchers looked back at medical records rather than testing a new treatment — and it focused on counting how often participants had experienced serious flare-ups (called "exacerbations") of their COPD in the one and two years before their visit. A moderate flare-up was defined as one serious enough to require steroid tablets or antibiotics, and a severe flare-up was one that led to a hospital stay. The reported data shows that among the 432 participants who were on inhaled corticosteroids, 62.5% had not experienced a moderate or severe flare-up in the previous year, while 37.5% had experienced at least one. Looking back over two years, 46.8% of the ICS group had experienced a flare-up and 53.2% had not. The reported average number of flare-ups per person in the ICS group was 0.72 over one year and 1.27 over two years. For the 469 participants who were not on inhaled corticosteroids, the reported data shows that 83.4% had no flare-up in the previous year (16.6% had one), and 77.2% had none in the previous two years (22.8% had one). Their reported average number of flare-ups was 0.26 over one year and 0.43 over two years. 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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NCT02465567 · results posted 2 February 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 8,588 people across four treatment groups, all of whom had COPD (a lung condition). The four groups each received a different inhaled combination of medicines delivered by a pressurised inhaler: two groups received a triple combination called BGF MDI (at different doses), one group received a double combination called GFF MDI, and one group received a different double combination called BFF MDI. The trial's main focus was on measuring the rate of moderate or severe COPD flare-ups (called exacerbations — episodes where symptoms worsen significantly) over the course of the study. Between roughly 1,580 and 1,713 participants in each group completed the trial. The reported data shows that the adjusted rate of moderate or severe flare-ups per year was 1.08 for the higher-dose BGF group, 1.07 for the lower-dose BGF group, 1.42 for the GFF group, and 1.24 for the BFF group. For the secondary outcomes, the number of participants who experienced at least one moderate or severe flare-up was 1,026, 1,013, 1,056, and 1,085 across the four groups respectively (noting that the median time to a first flare-up was not reached during the study). Average daily use of a reliever inhaler (Ventolin) changed by −1.2, −1.0, −0.7, and −0.8 puffs per day from the start of the study across the four groups. The number of participants recording a meaningful improvement on a respiratory quality-of-life questionnaire (SGRQ) was 1,068, 1,024, 893, and 949. The rate of severe flare-ups was 0.13, 0.14, 0.15, and 0.16 per year across the groups. Deaths from any cause during the study were reported as 28, 39, 49, and 34 participants in each group 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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NCT03159091 · results posted 11 December 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03159091) enrolled 238 people with a chronic cough related to chronic obstructive pulmonary disease (COPD) — a long-term lung condition that makes it harder to breathe. Of these, 121 were assigned to receive a medicine called Rengalin and 117 received a placebo (a dummy treatment with no active ingredient). The trial ran for four weeks and was mainly measuring whether people's cough severity improved, using a scoring tool called the Cough Severity Scale (CSS), where 0 means no cough at all and 5 means a constant, exhausting cough day and night. The reported data shows that for the main measure — the number of people whose CSS score dropped by at least one point compared to their starting score — 97 out of 121 people in the Rengalin group and 82 out of 117 in the placebo group met this response. For the secondary measures, average CSS scores at the start were similar in both groups (around 4.1–4.2 out of 10), and after four weeks both groups showed lower average scores (approximately 2.6 for Rengalin and 2.8 for placebo). The reported data also shows that 49 people in the Rengalin group and 37 in the placebo group had their cough score drop by 50% or more. Regarding COPD symptom scores (measured on a separate 0–40 scale, where higher is worse), both groups started around 20 points and both dropped — by about 3.3 points in the Rengalin group and 2.5 points in the placebo group. For COPD flare-ups (sudden worsening of symptoms requiring extra treatment), 115 out of 121 Rengalin participants and 113 out of 117 placebo participants reported no flare-up during the 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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NCT02649218 · results posted 14 August 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02649218) enrolled 226 adults with a condition called Chronic Spontaneous Urticaria (CSU) — a form of ongoing hives that appears without a clear trigger. All participants received a treatment called ligelizumab over approximately one year, as a follow-on from an earlier study. By the end of the trial, 201 participants had completed it, while 25 did not finish. The trial was measuring two main things: how many participants experienced unwanted health events (called adverse events) during treatment, and how many participants had their hives kept well under control over time, using a standard scoring tool called the UAS7 (a weekly diary-style score that tracks hive severity and itch). The reported data shows that out of 226 participants, 190 experienced at least one adverse event (an unwanted health event, which can range from mild to serious) during the treatment period. Regarding hive control, the UAS7 score was used — a score of 6 or below on this scale is considered "well controlled." The reported data shows that at one measurement point only 1 participant had a score at or below 6, while at a later point (around the end of the one-year treatment period) 138 participants had a score at or below 6, and at the end of a follow-up period after treatment stopped, 64 participants still had a score at or below 6. A separate reported figure shows that among those who had achieved well-controlled disease by the end of treatment, approximately 28% maintained that level through the follow-up period, compared to around 61% and less than 1% at other time points — though the trial data does not provide full context for each of these individual figures. 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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NCT03165045 · results posted 1 April 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,351 people who were using a combination inhaler called Spiolto® Respimat®. There was only one group — everyone received the same inhaler. The trial was measuring several things over roughly six weeks, including a "therapeutic success" rate, changes in a health questionnaire score (called the CCQ, which asks 10 questions about symptoms, daily functioning, and mental state), how doctors rated patients' general condition, and how satisfied patients were with the inhaler. The reported data shows that 756 out of the 1,140 people who completed both study visits met the definition of "therapeutic success." For the CCQ questionnaire (where a lower score means better status), the reported average change in the overall score was a decrease of 0.84 points, and a related four-question version of the score (CCQ-4) showed a decrease of 0.75 points — the study noted that a change of 0.4 points was considered the smallest meaningful difference. Regarding doctors' ratings of patients' general condition, the reported data shows a shift in the spread of scores between the start and end of the study, with more patients rated in the higher (better) categories at the final visit compared to the start. The reported data also shows that 1,194 of the participants said they would be willing to continue using the inhaler. For patient satisfaction at the final visit, the reported data shows that the majority of participants indicated they were satisfied or very satisfied with the inhaler, though the exact labels for each satisfaction category were not included in the data provided here. It is also worth noting that the satisfaction scale used was designed by the study's sponsor and has not been publicly validated. 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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NCT01973998 · results posted 12 March 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT01973998) looked at a medicine called roflumilast compared to a placebo (a dummy treatment with no active ingredient) in people who had been hospitalised with a flare-up of COPD (a lung condition). A total of 68 people took part — 33 received roflumilast and 35 received placebo. The main thing the trial was measuring was how long it took before someone either died from any cause or was admitted to hospital again, tracked over 180 days (about six months) after joining the trial. The reported data shows that, for the primary measure — the number of days until death or re-hospitalisation — the median (meaning the middle value in the group, where half the participants took longer and half took less time) was 54 days for the roflumilast group and 55 days for the placebo group. For the secondary measure, which counted events specifically related to respiratory (breathing-related) death or breathing-related re-hospitalisation over 180 days, the roflumilast group had 21 such events reported, compared with 29 in the placebo group. A smaller number of people did not complete the study — 2 in each group — though the reasons were not detailed in the data provided. The reported data also includes counts of various adverse events (unwanted side effects or health problems noted during the study) across both groups, though the specific breakdown of what each number refers to was not clearly labelled in the submitted data, so those individual figures cannot be described in detail here. Two people in the roflumilast group and two in the placebo group did not finish the study, but further detail on why was not reported in the available 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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NCT03391115 · results posted 27 December 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT03391115) involved two groups of people: 20 hospital inpatients and 18 nurses. All 38 participants who started the study completed it, with no drop-outs from either group. The trial was exploring whether it was feasible and practical to incorporate a patient's personal story — a kind of narrative about who they are — into their electronic health record (EHR), and what the key people involved thought about using such a system. The reported data shows that the main thing being measured was whether exit interviews (conversations held with participants after the experience) could be completed with all participants. According to the results reported on ClinicalTrials.gov, all 20 inpatients and all 18 nurses did complete these interviews. The interview responses were descriptive in nature — capturing people's thoughts and opinions — rather than producing numerical scores, so no single number summarises what the patients said. Separately, the nurses completed a usability assessment called the System Usability Scale (SUS), which is a questionnaire that produces a score between 0 and 100, where a higher number means the system was considered easier and more practical to use. The reported data shows the nurses gave an average SUS score of 89.71 out of 100. No SUS score was reported for the inpatient 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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NCT01833026 · results posted 24 December 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01833026) involved 56 people in total — 34 in an "Intervention" group and 22 in a "Usual Care" group. All 56 participants completed the study with no drop-outs recorded. The trial was looking at whether a breathing test called spirometry, used alongside a doctor's existing diagnosis, could accurately confirm whether a patient truly had a form of permanent airway narrowing — the kind associated with conditions like COPD (Chronic Obstructive Pulmonary Disease). The intervention group had this breathing test done at the start, while the usual care group had it done at the end of the one-year study period. The reported data shows that the primary outcome measured was the number of participants whose diagnosis of irreversible airway narrowing was confirmed as accurate by the breathing test results. According to the results reported on ClinicalTrials.gov, 10 out of 34 participants in the intervention group had an accurately classified diagnosis, compared with 5 out of 22 participants in the usual care group. No secondary outcome measures were included in the submitted results data, so figures for any additional measurements were not reported. It is worth noting that the numbers involved in this trial were quite small, which limits how much can 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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NCT00147069 · results posted 5 December 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total, split evenly into four groups of 15: healthy controls, people with asthma, smokers without a lung condition called COPD (Chronic Obstructive Pulmonary Disease), and smokers with COPD. All 60 participants completed the study with no dropouts. The trial was measuring certain proteins and immune cells found in mucus (sputum) coughed up from the lungs, with the aim of comparing levels across these four groups. The proteins being measured — called Matrix Metalloproteinases, or MMPs — are substances the body produces that are involved in breaking down and remodelling tissue. The reported data shows the following numbers from sputum samples. For total inflammatory cells (immune cells found in the mucus), levels were broadly similar across three groups — 2.3, 2.1, and 1.9 million cells per millilitre for healthy controls, people with asthma, and non-COPD smokers respectively — while the COPD smokers group recorded a notably higher figure of 5.2 million cells per millilitre. For the protein MMP1, reported levels were 11.0 ng/ml (controls), 12.5 ng/ml (asthmatics), 16.5 ng/ml (non-COPD smokers), and 34.5 ng/ml (COPD smokers). For MMP3, the reported figures were 7.2, 4.5, 5.8, and 5.4 ng/ml across the four groups in the same order. For MMP8, the reported figures were 208.6 ng/ml (controls), 188.5 ng/ml (asthmatics), 443.5 ng/ml (non-COPD smokers), and 1,575 ng/ml (COPD smokers). No secondary outcome measures were included in the data submitted to ClinicalTrials.gov, so only the primary measurements described above can be 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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NCT03034967 · results posted 29 November 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 614 people with COPD (chronic obstructive pulmonary disease) across six groups of roughly 102–103 participants each. One group received a placebo (a dummy treatment with no active ingredient), while the other five groups received different doses of a medicine called danirixin (5 mg, 10 mg, 25 mg, 35 mg, or 50 mg). The trial was measuring changes in breathing-related symptoms — including breathlessness, cough and mucus, and chest symptoms — using a structured questionnaire scoring tool, as well as tracking adverse events (unwanted medical occurrences) and certain blood test results. The reported data shows that all six groups, including the placebo group, recorded lower symptom scores at the end of the trial compared to the start — meaning scores moved in a favourable direction across the board. On the overall symptom score (which runs from 0 to 40, where higher numbers mean worse symptoms), the placebo group's score fell by 2.11 points, while the danirixin groups fell by between 0.71 and 1.93 points depending on the dose. Similar patterns were reported for the breathlessness and cough/mucus sub-scores. For chest symptoms, the reported change was nearly identical across all groups (around −0.34 to −0.36 points). Regarding adverse events, between 63 and 71 participants in each group experienced at least one adverse event, and serious adverse events were reported in 7 to 13 participants per group. The reported data shows no participants in any group had blood test results outside the pre-defined ranges of potential clinical importance for the "high" category, and none fell outside the "low" threshold either. 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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NCT03064113 · results posted 14 November 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 32 participants in total, split into four groups of eight. It was a crossover study, meaning every participant tried all four treatments one after another, with a seven-day "washout" rest period between each. The four treatments compared were: a placebo (inactive treatment), two doses of an inhaled medicine called TD-4208 (700 micrograms and 350 micrograms), and a comparator inhaled medicine called ipratropium (500 micrograms). The main thing being measured was lung function — specifically a breathing test called FEV1, which measures how much air a person can forcefully breathe out in one second. The reported data shows that for the primary measure — peak FEV1 relative to a starting baseline — the placebo group recorded an average of 1,708 mL, while the TD-4208 700 µg group recorded 1,877 mL, the TD-4208 350 µg group recorded 1,882 mL, and the ipratropium group recorded 1,884 mL. For the secondary measures, the reported data shows broadly similar patterns across the lung function tests (including measurements of overall breathing over time and the capacity of the lungs to fully expand), with the three active treatment groups generally recording somewhat higher numbers than the placebo group across most time points. The reported data for forced vital capacity (a measure of total air the lungs can hold) also showed higher numbers in the active treatment groups compared to placebo at 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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NCT03250689 · results posted 8 November 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people in total — 5 received a placebo (an inactive treatment used for comparison) and 14 received a drug called danirixin hydrobromide at a dose of 35 mg. All 19 participants completed the study. The trial was measuring changes in substances found in sputum (mucus coughed up from the lungs) that are linked to a type of immune activity called NETs (Neutrophil Extracellular Traps), which are web-like structures released by certain white blood cells. The study also tracked blood pressure, heart rate, and the number of participants who experienced any unwanted medical events. The reported data shows that for the main outcome — the percentage change in a NETs-related marker (histone-elastase complexes) measured in sputum — both groups showed reductions from their starting levels at one time point, with the placebo group showing a 3.2% reduction and the danirixin group showing a 9.4% reduction. At another time point, the placebo group showed a 30.5% reduction and the danirixin group showed a 13.6% reduction. For a second way of measuring NETs (DNA-elastase complexes), the reported changes from baseline varied across time points for both groups, with some going up and some going down. For the microscopy measurement (how much of a microscope image was covered by NETs), results at one time point were not reported for either group; at another time point, the placebo group showed a small increase of 0.9 percentage points and the danirixin group showed a small decrease of 0.259 percentage points. Regarding unwanted medical events, 3 out of 5 placebo participants and 6 out of 14 danirixin participants experienced an adverse event (an unintended medical occurrence during the study), and no serious adverse events were reported in either group. Blood pressure and heart rate changes were small and varied across time points 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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NCT02722304 · results posted 8 October 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02722304) set out to compare two medicines — ARALAST NP and GLASSIA — against a placebo (an inactive dummy treatment) in people with a condition called alpha-1 antitrypsin deficiency, which can cause progressive lung damage. The trial tested different doses of each medicine. A very small number of people took part: across all five groups, only 7 people started the study (1 in the ARALAST NP 60 mg/kg group, none in the ARALAST NP 120 mg/kg group, 2 in each of the two GLASSIA groups, and 2 in the placebo group), and none of the participants completed the study. The main thing being measured was the rate of change in lung density over time, assessed using CT scans. The reported data shows that for the primary outcome — the rate of change in lung density comparing the treatment groups to placebo — no measurements were recorded. The same applies to several secondary outcomes, including the rate of lung density change for each individual group and blood concentration levels of the active protein in each medicine. Because the trial did not complete and so few participants were treated, these figures were simply not reported. The reported data does include some numbers for adverse events (unexpected medical occurrences during the study). In the placebo group, 19 non-serious adverse events were recorded across 2 participants treated, representing 50% of participants in that group experiencing at least one such event. For the treatment groups (ARALAST NP 60 mg/kg, GLASSIA 60 mg/kg, and GLASSIA 120 mg/kg), zero adverse events of this type were recorded — though it is important to note that only a very small number of people were actually treated in those groups. 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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NCT02371629 · results posted 9 August 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 776 adults with COPD (a chronic lung condition), split into two equal groups of 388 people each. One group received a medication called NVA237 twice a day, and the other received it once a day. The trial was primarily measuring a lung function test called FEV1 — this is the amount of air a person can forcefully breathe out in one second — specifically looking at how much this changed from the start of the trial to week 12. Around 362–363 participants in each group completed the trial. The reported data shows that at week 12, the twice-daily group's trough FEV1 (a measurement taken roughly 24 hours after dosing, reflecting the lowest point of the medication's effect) increased by an average of 0.092 litres from their starting level, while the once-daily group's increased by 0.059 litres. Several secondary measurements were also reported. Looking at lung function over different windows of time during the day at week 12, the twice-daily group generally showed larger reported changes from baseline than the once-daily group, including a small negative figure (−0.019 litres) for the once-daily group in the 12–24 hour window. Participants also completed a quality-of-life questionnaire (the St. George's Respiratory Questionnaire, scored 0–100 where lower scores mean better health status). The reported data shows that at week 12, average scores fell by 5.3 points in the twice-daily group and 3.6 points in the once-daily group; at week 26, they fell by 6.6 and 4.6 points respectively. When looking at the proportion of people whose score dropped by 4 or more points (the pre-defined threshold for a meaningful change), the reported figures were approximately 55% (twice daily) versus 47% (once daily) at week 12, and 59% versus 50% at week 26. 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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NCT02642614 · results posted 5 August 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02642614) involved 120 people divided into four equal groups of 30. Each group received either a dummy pill (placebo) or one of three doses of an experimental medicine called BI 1026706 — 5 mg, 25 mg, or 100 mg — taken over a treatment period of 28 days. The trial was primarily measuring how often unwanted health events (called "treatment-emergent adverse events," meaning any health problems that appeared or worsened after starting treatment) occurred in each group. It also collected information on how the drug moved through participants' bodies (such as how quickly it was absorbed into the bloodstream) and looked at changes in a type of immune cell, called neutrophils, in participants' sputum (mucus coughed up from the lungs). The reported data shows that, for the primary outcome — the proportion of people who experienced any treatment-emergent adverse event — the figures were: 60.0% in the placebo group, 46.7% in the 5 mg group, 66.7% in the 25 mg group, and 53.3% in the 100 mg group. For the secondary outcome looking at changes in neutrophil counts in sputum, the reported figures (in millions of cells per millilitre) were 2.12 for placebo, 3.37 for the 5 mg group, 3.35 for the 25 mg group, and 3.06 for the 100 mg group. Regarding how the drug was absorbed, the reported data shows that the peak blood concentration of BI 1026706 after the first dose was reached at approximately 1 hour across all three dose groups, with higher doses corresponding to higher measured concentrations in the blood. 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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NCT02937584 · results posted 24 July 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 23 participants in total, split across two groups who received the two treatments in different orders — this is known as a "crossover" design, meaning each person tried both treatments at different times, with a washout period (a break between treatments) in between. The trial was measuring how two inhaled medicines — glycopyrronium (GP MDI) and formoterol fumarate (FF MDI) — affected the airways, using specialised imaging to look at airway size and airway resistance (how easy or difficult it is for air to flow through the airways). By the end of the study, 19 participants completed both treatment periods. The reported data shows that for the main (primary) outcomes, airway volume — a measure of how much space is inside the airways — was reported as a ratio compared to each person's starting point (a ratio above 1.0 means the volume increased from baseline). For GP MDI, the reported ratio was 1.11, and for FF MDI it was 1.23. For airway resistance — where a ratio below 1.0 means resistance decreased from baseline — GP MDI returned a ratio of 0.75, while FF MDI returned a ratio of 0.56. The reported data also shows secondary (additional) outcomes: uncorrected airway volume ratios were 1.12 for GP MDI and 1.21 for FF MDI; uncorrected airway resistance ratios were 0.76 and 0.55 respectively. A standard breathing test (FEV1, measuring how much air a person can breathe out in one second) showed a reported change from baseline of +0.065 litres for GP MDI and +0.151 litres for FF MDI. A measure of air remaining in the lungs after a normal breath out (functional residual capacity) had ratios of 0.978 for GP MDI and 0.938 for FF MDI. 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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NCT02729051 · results posted 15 July 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,055 people with COPD (a chronic lung condition). Participants were split into two groups of roughly 527 each. One group received a single inhaler combining three medicines — fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) — while the other group received the same three medicines but delivered as two separate inhalers taken together. The trial ran for 24 weeks and was primarily measuring whether the two ways of delivering these medicines produced different results on lung function, specifically a breathing test called FEV1 (the amount of air a person can forcefully breathe out in one second). The reported data shows that for the main measurement — change in lung function (FEV1) after 24 weeks — the single-inhaler group showed an average improvement of 0.113 litres from their starting point, while the two-inhaler group showed an average improvement of 0.095 litres. For the secondary measurements, a quality-of-life questionnaire (scored 0–100, where lower is better) showed an average score improvement of about 5.8 points in the single-inhaler group and about 4.9 points in the two-inhaler group. Around 50% of participants in the single-inhaler group and 51% in the two-inhaler group were counted as "responders" on that same questionnaire (meaning their score improved by at least 4 points). For breathlessness scores, 56% of participants in both groups were counted as responders, and average breathlessness improvement scores were 2.0 and 1.9 respectively. For the time to a first moderate or severe flare-up of COPD symptoms, the reported data shows no median value was able to be calculated for either group, meaning not enough participants experienced such an event during the study period to produce that figure. 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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NCT02155660 · results posted 26 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 2,254 people with COPD across four groups: those receiving one of three doses of benralizumab (10 mg, 30 mg, or 100 mg) or a placebo (a dummy injection with no active medicine). The trial ran for 56 weeks and was mainly measuring how often participants had COPD flare-ups — called exacerbations — which are episodes where symptoms worsen enough to need steroid tablets, antibiotics, or a hospital stay. A key focus was on participants who had higher levels of a type of white blood cell called eosinophils (220 or more per microlitre of blood) at the start of the trial, as these cells are linked to airway inflammation. The reported data shows that, among participants with higher eosinophil levels at the start, the estimated number of flare-ups per year was 0.99 for the 10 mg group, 1.21 for the 30 mg group, 1.09 for the 100 mg group, and 1.17 for the placebo group. Among participants with lower eosinophil levels, the reported rates were 1.23, 1.27, 1.21, and 1.18 flare-ups per year respectively. The secondary outcomes — including small changes in a lung function measurement (the amount of air someone can forcefully breathe out in one second), and scores from questionnaires measuring quality of life and symptom burden — showed modest numerical changes across all groups, including the placebo group, and the data as submitted does not include the statistical comparisons needed to say whether any differences between groups were meaningful. 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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NCT02516592 · results posted 21 March 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02516592) enrolled 251 people in each of two groups — one group took QVA149 (a combination inhaler at 110/50 micrograms) and the other took Salmeterol/Fluticasone (another combination inhaler at 50/500 micrograms). Both groups had participants with COPD (a long-term lung condition). The main thing the trial was measuring was a lung function test called FEV1 — essentially how much air a person can forcefully breathe out in one second — and how that changed after 12 weeks of treatment compared to the start of the trial. The reported data shows that, for the primary measure, the QVA149 group had a small average increase in their FEV1 of 0.036 litres from their starting point, while the Salmeterol/Fluticasone group had a small average decrease of 0.009 litres. For the secondary measures, a breathlessness score (where higher numbers mean more improvement) was reported as 3.24 for the QVA149 group and 2.79 for the Salmeterol/Fluticasone group — both above the threshold of 1 that the trial defined as a meaningful change. A general COPD symptom score (where lower is better) came out at 13.4 for the QVA149 group and 13.8 for the Salmeterol/Fluticasone group at week 12. Another lung measure (FVC, the total amount of air breathed out) showed an average increase of 0.073 litres in the QVA149 group and a decrease of 0.028 litres in the Salmeterol/Fluticasone group. The reported data shows that daily use of rescue inhaler puffs was similar in both groups — averaging about 1.05 puffs for the QVA149 group and 1.09 puffs for the Salmeterol/Fluticasone 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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NCT02343458 · results posted 20 February 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,756 participants across four groups: one group received a combination inhaler containing two active medicines (GFF MDI, 555 people), two groups each received one of those medicines on its own (FF MDI, 483 people; GP MDI, 480 people), and one group received a dummy inhaler with no active medicine (placebo, 238 people). The trial was measuring changes in lung function — specifically a breathing test called FEV1 (the amount of air a person can forcibly breathe out in one second) — over 24 weeks. It also measured changes in participants' self-reported breathlessness using a scoring tool. The reported data shows that, when looking at the change in FEV1 from the start of the trial to week 24, the combination inhaler group showed an average increase of around 120–135 millilitres (mL) depending on the analysis method used, the FF MDI group showed increases of around 47–63 mL, the GP MDI group showed increases of around 60–80 mL, and the placebo group showed a small average decrease of around 20–45 mL. For breathlessness, participants rated changes on a scale from −9 (major worsening) to +9 (major improvement). The reported data shows average scores over 24 weeks of approximately 1.6 for the combination inhaler group, 1.3–1.5 for the two single-medicine groups, and 0.8 for the placebo group — all representing small positive shifts from baseline across all 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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NCT03095456 · results posted 31 December 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 207 people in total — 103 in the Revefenacin group and 104 in the Spiriva Handihaler® group. The trial ran over approximately 29 days and was mainly measuring changes in lung function, specifically a breathing test called FEV1 (which stands for the amount of air a person can forcefully breathe out in one second). By the end of the trial, 99 people in the Revefenacin group and 96 in the Spiriva Handihaler® group had completed it. The reported data shows that, for the main outcome — change in trough FEV1 (a measurement taken before the next dose, reflecting the lowest level of effect) from the start to Day 29 — the Revefenacin group showed an average increase of 63.0 mL, while the Spiriva Handihaler® group showed an average increase of 47.3 mL. For the secondary outcomes, the reported data shows changes in other lung measurements from the start to Day 29: forced vital capacity (the total amount of air breathed out forcefully) increased by 125.4 mL for Revefenacin and 55.8 mL for Spiriva Handihaler®; inspiratory capacity (how much air can be breathed in) changed by 71.4 mL and 84.1 mL respectively. Peak FEV1 (the highest reading after a dose) increased by 174.2 mL for Revefenacin and 197.7 mL for Spiriva Handihaler®, and peak forced vital capacity increased by 354.2 mL and 340.1 mL respectively. The reported data also shows that participants used an average of 3.4 puffs per day of rescue medication in the Revefenacin group and 2.9 puffs per day in the Spiriva Handihaler® 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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NCT02573155 · results posted 8 November 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02573155) was run in two parts. Part 1 enrolled 16 people with mild persistent asthma, and Part 2 enrolled 38 people with chronic obstructive pulmonary disease (COPD — a long-term lung condition that makes it hard to breathe). Both groups were given single doses of an investigational inhaled medicine called AZD8871 at various dose levels, alongside comparison treatments (including two already-approved inhaled medicines, indacaterol and tiotropium, in Part 2) and a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring unwanted medical events that occurred during treatment, changes in blood pressure and heart tracings (ECGs), blood and urine test results, and a standard breathing test called FEV1 — which measures how much air a person can forcefully breathe out in one second. The reported data shows that, looking at unwanted medical events during treatment, numbers of participants who experienced at least one such event ranged from 2 to 7 people across the different AZD8871 dose groups in Part 1 (out of the 16 asthma participants), and 7 to 18 people across the treatment groups in Part 2 (out of the 38 COPD participants). For blood pressure and heart tracing (ECG) results, the reported data shows zero participants in any group had readings flagged as clinically relevant abnormalities (meaning unusual enough to be of medical concern). Similarly, zero participants in any group had clinically relevant abnormal results in blood or urine tests. For the breathing test (FEV1), the reported data shows changes from the starting measurement on Day 2 ranged from a small decrease of around 0.06 litres in the placebo group (Part 1) to an increase of around 0.46 litres in the highest AZD8871 dose group tested in Part 1. In Part 2, the reported changes in FEV1 ranged from a small decrease of around 0.03 litres with placebo to an increase of around 0.17 litres with the higher AZD8871 dose. Blood concentration data for AZD8871 was also reported for the groups that received the active medicine; the placebo and comparison medicine groups did not have AZD8871 concentration data reported, as expected. 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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NCT03094806 · results posted 11 October 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT03094806) enrolled 91 people in hospital — 44 used an Acapella vibratory PEP (positive expiratory pressure) device, a handheld breathing gadget that creates vibrations and resistance when you breathe out, while 47 used a sham (fake) version of the same device that looked identical but did not work. All 91 participants completed the study. The trial was measuring how long people stayed in hospital, how much mucus they coughed up each day, how breathless they felt, how far they could walk in six minutes, and how well air moved through their lungs. The reported data shows that the primary outcome — length of hospital stay — was 4.8 days on average for the group using the real device, compared with 3.2 days for the group using the sham device. For daily mucus production (measured in millilitres over 24 hours), the sham group consistently reported higher volumes across each day of measurement than the real-device group. Breathlessness scores, measured on two different rating scales over several time points, were broadly similar between the two groups. For the six-minute walk test — how far someone could walk in six minutes — the reported data shows starting distances of 168.8 metres (real device) and 206.7 metres (sham), and end-of-study distances of 200.1 metres and 199.3 metres respectively. A lung airflow ratio (how much air can be pushed out quickly compared with a full breath out) was reported as 70.7 for the real-device group and 57.7 for the sham group, though the data did not report which time points these figures came from. 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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NCT02164513 · results posted 10 October 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 10,355 people with COPD (a chronic lung condition) across three treatment groups: 4,151 received a triple inhaled medicine combination (FF/UMEC/VI), 4,134 received a two-medicine combination (FF/VI), and 2,070 received another two-medicine combination (UMEC/VI). The trial was primarily measuring how often participants experienced moderate or severe flare-ups (called exacerbations) of their COPD over the course of the study — where "moderate" meant needing steroids or antibiotics, and "severe" meant needing hospitalisation or resulting in death. A range of secondary measures were also tracked, including lung function, quality of life, and how long it took for a first flare-up to occur. The reported data shows that the average number of moderate or severe flare-ups per person per year was 0.91 in the triple-medicine group, 1.07 in the FF/VI group, and 1.21 in the UMEC/VI group. For lung function (measured by how much air someone can breathe out in one second), the triple-medicine group showed an average change of +0.094 litres from the start of the study to week 52, compared with –0.003 litres in the FF/VI group. On a quality-of-life questionnaire scored from 0 to 100 (where lower scores mean better quality of life), scores decreased by an average of 5.5 points in the triple-medicine group and 3.7 points in the FF/VI group. Regarding the time to a first flare-up, the reported first-quartile figures (meaning the point by which one quarter of participants had experienced a flare-up) were 112 days for the triple-medicine group, 81 days for FF/VI, and 73 days for UMEC/VI. In a subgroup of participants with higher levels of a blood marker called eosinophils (at least 150 cells per microlitre), the reported flare-up rate was 0.95 per person per year in the triple-medicine group and 1.39 in the UMEC/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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NCT02477332 · results posted 14 September 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called ligelizumab (also referred to as QGE031) for people with chronic hives (urticaria). A total of 382 participants were enrolled across six groups: three groups received different doses of ligelizumab every four weeks (24 mg, 72 mg, or 240 mg), one group received a single dose of ligelizumab (120 mg), one group received an existing treatment called omalizumab (300 mg every four weeks), and one group received a placebo (an inactive injection). The trial's main goal was to measure how many participants reached a "complete hives response" — meaning their hive severity score dropped to zero — at 12 weeks, and to look at how different doses compared to omalizumab. The reported data shows that for the primary outcome at Week 12, the percentage of participants whose hive scores reached zero was: 30.2% in the 24 mg ligelizumab group, 51.2% in the 72 mg group, 42.4% in the 240 mg group, 25.9% in the omalizumab group, 19.0% in the single-dose ligelizumab group, and 0% in the placebo group. For the secondary outcomes, the reported data shows that hive severity scores (on a possible scale of 0–21) dropped from baseline by around 9.75 points (24 mg group), 15.50 points (72 mg), 13.50 points (240 mg), 11.00 points (omalizumab), and 6.50 points (placebo) at Week 12. Similar patterns were reported at Week 20. Itch severity scores (also on a 0–21 scale) at Week 12 were reported to have fallen by 7.50, 9.50, 9.00, 8.00, and 5.50 points in those same groups 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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NCT01106833 · results posted 14 August 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 151 people in total — 74 in a group receiving three medicines (sirolimus, a calcineurin inhibitor, and prednisone) and 77 in a group receiving two medicines (sirolimus and prednisone). The trial was studying treatments for chronic graft-versus-host disease (a condition that can occur after a stem cell or bone marrow transplant, where donated immune cells attack the recipient's body). The main thing being measured was "treatment success" — defined as achieving a good response without needing extra immune-suppressing medicines, and without the original illness returning or the person dying — checked at 6 months and again at 24 months. The reported data shows that at 6 months, 33 out of 74 participants in the three-medicine group and 35 out of 77 in the two-medicine group met the treatment success definition. At 24 months, those numbers were 9 out of 74 and 10 out of 77 respectively (note: the data as submitted includes multiple sets of figures across trial phases, and not all breakdown details were fully labelled in the submission). For survival at around 1 year, the reported data shows approximately 85.5% of the three-medicine group and 91.7% of the two-medicine group were alive; at around 2 years, those figures were reported as 74.0% and 81.5%. The reported rate of cancer returning by 2 years was 14.9% in the three-medicine group and 10.1% in the two-medicine group. The percentage of participants who needed to start additional immune-suppressing treatment by 2 years was reported as 29.4% and 38.5% respectively. The reported data shows that other measures — such as survival without cancer relapse, and survival without either relapse or needing extra treatment — followed broadly similar patterns between the two groups across both time points, with the specific figures listed above. It is worth noting that some of the numerical entries in the submitted data were not clearly labelled to individual time points in the original submission, so not every figure could be fully attributed to a specific timeframe. 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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NCT02579772 · results posted 14 June 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants across two groups. It was a crossover study, meaning participants took both treatments at different times — one group started with N-acetylcysteine (a supplement) and then switched to a placebo (an inactive treatment), while the other group did it in reverse order. The trial was measuring two main things: levels of a natural antioxidant called glutathione in the blood, and how long participants could keep cycling before exhaustion. Nine of the 13 participants completed the study; four did not complete it, though the reasons were not detailed in the data provided. The reported data shows that, during the N-acetylcysteine period, average blood glutathione levels were measured at 8.97 micromolar, compared to 7.05 micromolar during the placebo period. For cycling time before exhaustion, participants averaged 336 seconds (just under 5.6 minutes) during the N-acetylcysteine period and 325 seconds (just under 5.5 minutes) during the placebo period. The reported data also shows several secondary measurements taken during the cycling test — including heart output (how much blood the heart pumps per minute), muscle oxygen use, blood flow in the muscles, and overall oxygen uptake by the lungs. The numbers for these measures were very similar between the two periods, ranging from 12.5 vs. 12.1 litres per minute for heart output, and virtually identical figures (19.0 seconds each) for how quickly the muscles responded to the exercise demand. 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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NCT02296138 · results posted 4 June 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled just under 7,900 people with COPD (chronic obstructive pulmonary disease — a long-term lung condition). Participants were split into two groups: one group received a single inhaled medicine called tiotropium (5 micrograms), and the other received a combination of tiotropium plus a second inhaled medicine called olodaterol (both at 5 micrograms). The trial's main focus was measuring how often participants experienced "moderate to severe COPD flare-ups" — meaning episodes where the condition worsened enough to need extra medical care — over the course of treatment. The reported data shows that, on average, the tiotropium-only group had 0.97 flare-ups per person per year, while the combination group had 0.90 flare-ups per person per year. In terms of how many individuals had at least one such flare-up, 1,777 people in the tiotropium-only group and 1,746 in the combination group recorded at least one episode. For flare-ups serious enough to require a hospital stay, the reported rate was 0.20 per person per year in the tiotropium-only group and 0.18 in the combination group, with 469 and 450 people respectively being hospitalised at least once. The reported data also shows that 32 people in the tiotropium-only group and 36 people in the combination group died from any cause 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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NCT02105948 · results posted 6 April 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 836 adults with chronic obstructive pulmonary disease (COPD) across four groups. Participants were divided based on a blood test result (a type of immune cell called an eosinophil) into a "high stratum" (higher eosinophil levels) and a "low stratum" (lower eosinophil levels), and within each group they were randomly assigned to receive either the medicine mepolizumab (100 mg) or a placebo (a dummy injection). The trial ran for 52 weeks and was mainly measuring how often participants had moderate or severe flare-ups of their COPD — that is, episodes serious enough to need steroid or antibiotic treatment, a hospital stay, or that resulted in death. The reported data shows that in the high-stratum group, participants on placebo had an average of 1.71 moderate or severe flare-ups per year, compared with 1.40 per year in those receiving mepolizumab. When all participants across both strata were combined, the reported rates were very close: 1.52 flare-ups per year on placebo versus 1.49 per year on mepolizumab. For the secondary outcomes in the high stratum, the reported data shows that by the end of the study, around 62% of the mepolizumab group and around 72% of the placebo group had experienced at least one flare-up. Flare-ups serious enough to require an emergency department visit or hospitalisation were reported at 0.30 per year for mepolizumab and 0.26 per year for placebo in the high stratum. The reported data also shows changes in two questionnaire scores used to measure how COPD affected participants' daily lives. On the St. George's Respiratory Questionnaire (where lower scores mean better quality of life), both groups showed small reductions from their starting scores — minus 2.8 points for mepolizumab and minus 3.0 points for placebo. On the COPD Assessment Test (again, lower is better), the mepolizumab group showed a change of minus 0.8 points and the placebo group showed no change (0.0 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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NCT00372112 · results posted 22 February 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 68 people across four groups: 17 received a placebo (a dummy treatment with no active ingredient), 16 received a lower dose of the investigational medicine GW642444 (100 micrograms once daily), 17 received a higher dose of GW642444 (400 micrograms once daily), and 18 received a comparator medicine called salmeterol (50 micrograms twice daily). The trial's main focus was on tracking any unwanted medical events (called adverse events) that participants experienced, and it also measured changes in heart rate over the two-week treatment period using a wearable blood pressure monitor worn for around 28 hours at a time. The reported data shows that when it came to unwanted medical events, 4 out of 17 placebo participants, 5 out of 16 in the lower-dose GW642444 group, 7 out of 17 in the higher-dose GW642444 group, and 6 out of 18 in the salmeterol group experienced at least one such event. Serious events — those considered more significant, such as requiring hospitalisation — were reported for none in the placebo group, none in the lower-dose group, 1 in the higher-dose GW642444 group, and 1 in the salmeterol group. For heart rate, the trial tracked changes from each participant's starting point across different time windows. The reported numbers showed small variations in average heart rate across all four groups throughout the study, with changes of a few beats per minute in either direction depending on the group and time point measured. The data was not reported in a way that allows a straightforward single-sentence summary of all heart rate findings. 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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NCT00453479 · results posted 8 February 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people in total, split across three groups: 6 received a placebo (a dummy treatment with no active ingredient), 9 received a lower dose of the investigational medicine GSK233705 (50 micrograms twice daily), and 8 received a higher dose (100 micrograms twice daily). All 23 participants completed the trial with no one dropping out. The trial was measuring safety-related signs — specifically whether participants experienced any unwanted medical events (called adverse events) — as well as physical measurements including blood pressure and heart rate, taken at various points over seven days. The reported data shows that when it came to adverse events (any unexpected medical occurrence during the trial), 4 out of 6 participants in the placebo group, 4 out of 9 in the lower-dose group, and 4 out of 8 in the higher-dose group reported at least one such event. No serious adverse events — meaning no events involving hospitalisation, life-threatening situations, or lasting disability — were reported in any of the three groups. For blood pressure and heart rate, the reported data shows readings that were broadly similar across all three groups throughout the study period. For example, average systolic blood pressure (the "top number" in a blood pressure reading) at baseline ranged from about 128 to 130 across the groups, with similar ranges observed at later time points. Average heart rates at baseline were reported as approximately 66, 67, and 72 beats per minute for the placebo, lower-dose, and higher-dose groups respectively, with comparable figures recorded across the 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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NCT02075255 · results posted 17 October 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02075255) enrolled 220 adults with severe asthma who were dependent on oral corticosteroids (OCS) — a type of steroid tablet taken daily to manage their asthma. Participants were randomly assigned to one of three groups: benralizumab injected every 4 weeks (72 people), benralizumab injected every 8 weeks (73 people), or a placebo (dummy injection, 75 people). The trial ran for 28 weeks and was primarily measuring how much participants were able to reduce their daily steroid tablet dose while keeping their asthma under control. The reported data shows that, by the end of the trial, the median percentage reduction in daily steroid tablet dose was 75% in both benralizumab groups, compared with 25% in the placebo group. These are median figures — meaning half the participants in each group achieved more than this reduction and half achieved less. Among participants who had a higher level of a particular blood cell type (eosinophils ≥300/µL) at the start, the reported median reductions were also 75% in both benralizumab groups, compared with 0% in the placebo group. Looking at other measures, 48 out of 72 participants in the every-4-weeks group, 48 out of 73 in the every-8-weeks group, and 28 out of 75 in the placebo group were reported to have achieved at least a 50% reduction in their steroid tablet dose. Complete elimination of the steroid tablet dose was reported for 22 participants in each benralizumab group and 8 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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NCT01616056 · results posted 17 July 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people who wore bandage contact lenses — a type of soft lens placed on the eye for therapeutic rather than vision-correction purposes. Nineteen of the 20 participants completed the study, with one person not finishing. The trial was measuring changes in self-reported eye discomfort symptoms over time using three different questionnaire-based rating tools: the Lee Eye Subscale, the Ocular Surface Disease Index (OSDI), and an 11-point Eye Rating Scale. On all three tools, a lower score indicates fewer or less bothersome symptoms, and a higher score indicates more. The reported data shows that average scores on all three scales were lower at later measurement points compared to the starting point. On the Lee Eye Subscale (which runs from 0 to 100), the average score started at 75.4 and the later recorded figures were 63.2, 61.8, and 56.3. On the OSDI (also 0 to 100), the starting average was 54.5, with later figures of 36.8, 32.9, and 35.6. On the 11-point Eye Rating Scale (0 to 10), the starting average was 7.11, dropping to 5.00, 4.37, and then 3.94. The trial also counted how many participants showed what the researchers defined as a meaningful change on each scale. For the Lee Eye Subscale, between 9 and 11 participants (out of 19 who completed the study) reached that threshold at different time points. For the OSDI, between 10 and 13 participants did so, and for the 11-point scale, between 11 and 13 participants did so. The timing details for each measurement point were not 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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NCT02418468 · results posted 11 July 2017

According to the results reported on ClinicalTrials.gov, this trial compared a daily inhaled medicine called indacaterol (150 micrograms) against a placebo (a dummy treatment with no active ingredient) in people with a specific stage of a lung condition called COPD. A total of 24 people started the trial — 13 in the indacaterol group and 11 in the placebo group. After 12 weeks, 11 people in the indacaterol group and 10 in the placebo group completed the study. The main thing the trial measured was lung function — specifically, how much air a person could forcefully breathe out in one second (called FEV1, measured in litres). This was checked 24 hours after the last dose at the 12-week mark, giving what researchers call a "trough" reading — meaning the measurement taken at the lowest point, just before the next dose would be due. The reported data shows that the indacaterol group had an average FEV1 of 1.76 litres at that point, while the placebo group recorded an average of 1.86 litres. No secondary outcome measure results were included in the data submitted to ClinicalTrials.gov, so those figures cannot be reported here. It is worth noting that this was a very small trial, and the results as reported are limited to these two figures. 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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NCT01608490 · results posted 27 June 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01608490) enrolled 315 people in total — 158 in the group that received the RePneu Lung Volume Reduction Coil System (small coils placed in the lungs) and 157 in the group that continued with standard medical care. Of those, 141 and 142 participants respectively completed the study. The trial was measuring whether the coil procedure made a difference — compared to standard care — across several areas over 12 months, including how far participants could walk in six minutes, how much air they could breathe out quickly, how they rated their breathing-related quality of life, and how much air was left trapped in their lungs. The reported data shows the following numbers at the 12-month mark. For the main measure — change in distance walked in six minutes — the coil group's result improved by an average of 10.3 metres from their starting point, while the standard care group's result declined by an average of 7.6 metres. For a breathing test called FEV1 (a measure of how much air someone can forcefully breathe out in one second), the coil group showed an average increase of 3.8%, while the standard care group showed an average decrease of 2.5%. On a quality-of-life questionnaire scored from 0 to 100 (where a lower score is considered better), the coil group's score changed by −8.1 points and the standard care group's score changed by +0.8 points. The reported data also shows that 60 people in the coil group walked at least 25 metres more than they had at the start, compared with 41 people in the standard care group. On the quality-of-life questionnaire, 98 people in the coil group improved by at least 4 points, compared with 48 in the standard care group. Finally, a measure of air trapped in the lungs (residual volume) changed by −0.41 litres in the coil group and −0.10 litres in the standard 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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NCT02786927 · results posted 22 June 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 212 people who had been using inhalers to manage COPD (a lung condition). All participants tried two different types of inhaler — the ELLIPTA and the HandiHaler — and were then asked which they preferred across several aspects of use. Of the 212 who started, 207 completed the trial, and 5 did not finish. The trial was not measuring how well the inhalers treated COPD; it was measuring which inhaler people said they preferred, and why. The reported data shows that when participants were asked which inhaler they preferred based on the number of steps needed to take their medication (the primary question), 73% said they preferred the ELLIPTA, 20% said they preferred the HandiHaler, and 7% expressed no preference. For a secondary question — how easy it was to tell how many doses were left in the inhaler — 70% reported preferring the ELLIPTA, 18% preferred the HandiHaler, and 12% had no preference. When asked about the physical size of the inhaler, 52% preferred the ELLIPTA, 25% preferred the HandiHaler, and 24% had no preference. It is worth noting that this trial measured stated preference only — that is, what people said they liked better about each device — and did not measure health outcomes such as symptom control or lung function. The reported data shows only how participants answered the preference questionnaire under the conditions of this specific 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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NCT01488019 · results posted 12 June 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,071 people with COPD — 541 were assigned to receive Perforomist Inhalation Solution (a bronchodilator inhaled through a nebuliser) and 530 received a matching placebo (an inactive treatment that looked the same). The trial ran for up to 52 weeks and was primarily measuring how many participants experienced a serious breathing-related event: specifically, respiratory death, an emergency room visit related to COPD, or a hospital stay due to a COPD flare-up — whichever happened first. Not everyone finished the study; 294 in the Perforomist group and 226 in the placebo group completed it. The reported data shows that 64 participants in the Perforomist group and 57 in the placebo group experienced one of those primary serious events during the study. When researchers used a statistical method called Kaplan-Meier probability — which estimates the chance of an event occurring over the full 52-week period, accounting for people who left the study early — the figures were 15.5% for the Perforomist group and 14.9% for the placebo group. For secondary outcomes, the reported data shows that COPD flare-ups (defined as a worsening of symptoms lasting at least two days and requiring a change in medication) were recorded in 142 participants in the Perforomist group and 135 in the placebo group, with 52-week estimated probabilities of 34.7% and 34.0% respectively. Deaths from any cause were reported in 3 participants in the Perforomist group and 10 in the placebo group, though the trial was not specifically designed to measure this as a main outcome, and the reported data on COPD-related or respiratory-related deaths showed very small numbers (0–1 participants per 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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NCT01954628 · results posted 12 June 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01954628) enrolled 400 people with COPD — 200 received a daily oral dose of AQX-1125 (200 mg) and 200 received a placebo (a dummy pill with no active ingredient). The trial ran for 12 weeks and was primarily measuring changes in daily symptom scores using a questionnaire called the EXACT, which asks 14 questions about how frequently and severely COPD symptoms occur each day. Higher scores on the EXACT indicate worse symptoms, and when symptoms improve compared to the starting point, a positive number is calculated using a method called the "Area Above the Curve" (essentially a way of adding up the total improvement across the whole study period). The reported data shows that for the primary measure — total symptom improvement across the 12 weeks — the AQX-1125 group recorded a score of 415.4 and the placebo group recorded 391.7. For the secondary measures, a separate symptom questionnaire (the CAT, scored 0–40 where lower is better) showed a change of −4.05 in the AQX-1125 group and −3.71 in the placebo group, both indicating some reduction from their starting scores. The reported data also shows that COPD flare-ups (episodes needing prescription medication) occurred at a rate of 1.776 per year in the AQX-1125 group compared with 1.641 per year in the placebo group. The average number of days before a first flare-up was 38.1 days in the AQX-1125 group and 43.9 days in the placebo group. In total, 48 participants in the AQX-1125 group and 51 in the placebo group experienced at least one flare-up. A breathing test called FEV1 (measuring how much air a person can breathe out in one second) showed a change of −0.02 litres in the AQX-1125 group and +0.01 litres in the placebo group 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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NCT02645123 · results posted 8 June 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 75 adults who had low back pain. They were randomly placed into one of three groups — 25 people received spinal mobilisation (hands-on joint movement by a therapist), 25 received a sham (fake) treatment, and 25 received classic physiotherapy. All 75 participants completed the trial with no dropouts. The trial was measuring self-reported pain levels, self-reported physical disability, and walking movement patterns, assessed at multiple time points. The reported data shows the following for self-rated pain (scored 0–10, where 0 means no pain and 10 means the worst imaginable pain): before treatment, average scores were similar across all three groups (around 5.96, 6.12, and 6.00 respectively). At later measurement points, the spinal mobilisation group reported average scores of around 1.22 and 1.32, while the sham group reported scores of around 5.88 and 6.02, and the classic physiotherapy group reported around 4.96 and 5.08. For physical disability measured by two separate questionnaires, a similar pattern in the numbers was reported — the spinal mobilisation group's scores dropped noticeably from baseline, while the sham and classic physiotherapy groups showed smaller changes in their reported numbers. For the walking movement analysis — which compared the symmetry between the left and right sides of the body during walking (where a score of 1 means perfect symmetry) — the reported data shows varied numbers across groups and time points, and the results are more complex to summarise simply. The raw figures were not accompanied by additional statistical detail 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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NCT02196077 · results posted 9 May 2017

According to the results reported on ClinicalTrials.gov, 180 people started this trial, and 133 completed it. Participants were assigned to one of five different inhaler treatments — three different dose combinations of a triple-therapy inhaler called BFF MDI (at high, medium, and low doses), a single-medicine inhaler called BD MDI, or another single-medicine inhaler called FF MDI. The trial was measuring lung function over 29 days, specifically looking at how much air participants could breathe out — a common way of checking how open the airways are in conditions like COPD or asthma. The main thing being measured was a lung function reading called FEV1 (the amount of air a person can forcefully breathe out in one second), tracked over 12 hours on day 29. The reported data shows that, compared to where participants started, the change in this reading was 0.231 litres for the highest-dose BFF MDI group, 0.197 litres for the medium-dose group, 0.205 litres for the low-dose group, 0.176 litres for the FF MDI group, and 0.011 litres for the BD MDI group. The reported data also shows secondary measurements — such as morning lung readings and peak breathing readings on days 1, 15, and 29 — which followed a broadly similar pattern across the groups, with the BFF MDI groups generally recording higher numerical changes than the BD MDI group. A separate measure of overall lung capacity (FVC) on day 29 showed a similar pattern of reported numbers 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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NCT01085045 · results posted 26 April 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01085045) enrolled 122 participants in its first phase (Part A), of whom 104 went on to take part in the second phase (Part B). The trial was testing several different inhaled medicines — including combination inhalers containing two active ingredients (glycopyrrolate and formoterol fumarate together, labelled GFF MDI), as well as single-ingredient inhalers and a placebo — in people with a lung condition. The main thing the trial was measuring was how much air participants could breathe out in one second (a standard lung function test called FEV1), tracked over a 12-hour window after seven days of taking the assigned medicine. The reported data shows that for the primary measure — the overall amount of air breathed out across that 12-hour window on day seven — the two combination inhalers (GFF MDI at the higher and lower doses) recorded figures of 1.537 litres and 1.529 litres respectively, relative to each participant's starting point. The other medicines in the comparison recorded figures ranging from 1.413 to 1.437 litres. For the secondary measures, the reported data shows the largest single recorded improvement in FEV1 on day one ranged from 0.266 litres (Spiriva) to 0.370 litres (higher-dose GFF MDI), and on day seven from 0.298 litres (Spiriva) to 0.440 litres (lower-dose GFF MDI). Changes in a related breathing measure called inspiratory capacity (how much air can be breathed in) were also reported, ranging from roughly 0.31 to 0.50 litres across the different medicines on both days one and seven. The reported data also notes how many participants in each group reached a 10% or greater improvement in FEV1 on the first day, with numbers varying across the different treatment groups; however, some figures in this section of the data appear incomplete as submitted. No placebo comparison figures were included in the outcome measure results 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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NCT01572792 · results posted 21 April 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01572792) was an extension study that followed on from an earlier lead-in trial. It involved five groups of participants: people taking a placebo (an inactive treatment), two different combination doses of aclidinium/formoterol (400/12 µg and 400/6 µg), aclidinium alone (400 µg), and formoterol alone (12 µg). Across all five groups, a total of 1,692 people started the lead-in phase, and 921 went on to start the extension study, with between 121 and 179 people completing it in each group. The trial's main focus was on monitoring safety — specifically, tracking what unwanted events and changes in body measurements occurred during the study period. The reported data shows that the primary thing measured was the percentage of participants in each group who experienced any treatment-emergent adverse event (that is, any unwanted health event that occurred after starting the study treatment). The figures reported were: 56.8% for the placebo group, 65.9% for aclidinium/formoterol 400/12 µg, 61.3% for aclidinium/formoterol 400/6 µg, 67.5% for aclidinium 400 µg, and 64.6% for formoterol 12 µg. For the secondary measures, the percentage of participants with notable changes in blood or urine laboratory test results ranged from 32.5% to 41.2% across the groups. Notable changes on heart tracing tests (ECGs) were reported in roughly 48% to 60% of participants depending on the group. The reported data also shows changes in a lung function measurement called FEV1 (how much air a person can forcefully breathe out in one second) and a breathlessness score; the numbers for these additional measures varied across the groups, but the interpretation of those figures was not provided 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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NCT02573870 · results posted 28 March 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02573870) enrolled 62 participants in total — 20 in the placebo group and 42 in the active treatment group, who received an inhaled combination called BAT/FF at doses of 300/100 micrograms. All 20 participants in the placebo group finished the trial, while 35 out of 42 in the BAT/FF group completed it (7 did not finish). The trial was measuring how the study medications affected heart rate, tracked using heart tracings (ECGs) taken over a four-hour window after each dose. The reported data shows one primary outcome: the average change in heart rate (measured in beats per minute) from the starting point to Day 42, calculated across the four hours after dosing. In the placebo group, heart rate changed by approximately +0.69 beats per minute from baseline (meaning it was very slightly higher on average). In the BAT/FF group, heart rate changed by approximately −1.56 beats per minute from baseline (meaning it was very slightly lower on average). No secondary outcome data appears to have been reported in the structured results submitted to ClinicalTrials.gov. It is worth noting that these numbers reflect averages across the group and simply describe what was recorded during the trial — they do not on their own tell us what these small changes in heart rate mean for any individual person. 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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NCT01854645 · results posted 28 March 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01854645) enrolled 2,103 people across five groups to study the effects of different inhaled medicines on lung function in people with COPD (a chronic lung condition). The five groups were: GFF MDI (527 people), GP MDI (451 people), FF MDI (452 people), Spiriva® Handihaler® (453 people), and a placebo — an inactive treatment — (220 people). The main thing being measured was a change in lung function, specifically a breathing test called FEV1 (how much air a person can forcefully breathe out in one second), taken in the morning before any medication dose, after 24 weeks. The reported data shows that at 24 weeks, every group except the placebo group showed an increase in their morning FEV1 from where they started. The GFF MDI group's average result increased by 0.126 litres, the Spiriva® Handihaler® group by 0.105 litres, the GP MDI group by 0.066 litres, and the FF MDI group by 0.062 litres. The placebo group's average result decreased slightly by 0.024 litres. A secondary measure — looking at average lung function across the full 24 weeks — showed a similar pattern, with the GFF MDI group reporting the largest average increase of 0.150 litres. The reported data also shows that scores on a quality-of-life questionnaire (where lower scores mean better health status) decreased across all groups, with the GFF MDI group showing the largest reported change of -3.1 points. Additionally, the average number of puffs of rescue medication used per day decreased in all groups except the placebo group, which showed a small increase. 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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NCT00674817 · results posted 27 March 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 44 participants in total, all treated as a single group across multiple study periods. By the end of the trial, 38 participants had completed all stages. The trial was testing an investigational inhaled medicine called GSK961081, given at two different doses (400 mg and 1,200 mg), each combined with one of two existing "reliever" medicines — salbutamol (SAL) or ipratropium bromide (IPR) — or with a placebo (inactive) reliever. The main thing being measured was lung function, specifically how much air participants could forcefully breathe out in one second (a measurement called FEV1), and how that changed after taking the combinations of medicines. The reported data shows that, for the primary measurement (change in FEV1), all six treatment combinations were associated with increases from the starting point. At the 12-hour mark, the increases ranged from approximately 0.087 to 0.141 litres across the active combinations, compared to 0.072 and 0.094 litres in the two placebo-reliever groups. At 24 hours, the reported increases for the active combinations ranged from about 0.098 to 0.141 litres, while the placebo-reliever groups showed smaller figures of 0.002 and 0.043 litres. For the secondary lung measurement (FVC — the total amount of air that can be forcefully breathed out), similar patterns of change from baseline were reported across the groups, though the numbers varied. On the question of adverse events (unexpected medical occurrences during the trial), the reported data shows that between 6 and 15 participants in each treatment group experienced at least one adverse event. Two participants — one each in the 1,200 mg plus SAL group and the 400 mg plus IPR group — experienced a serious adverse event. Small changes in blood pressure and heart rate were also recorded across all groups, and only one participant (in the 1,200 mg plus SAL group) showed laboratory results flagged as potentially concerning. 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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NCT01437397 · results posted 23 March 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,692 people across five groups. Participants were randomly assigned to receive one of two combination doses of aclidinium/formoterol (400/12 μg or 400/6 μg), aclidinium alone (400 μg), formoterol alone (12 μg), or a placebo (an inactive treatment). The trial was measuring changes in lung function — specifically how much air participants could forcefully breathe out in one second (called FEV1) — both one hour after a morning dose and at the lowest point before the next morning dose. It also looked at changes in breathlessness and general respiratory health status. Between 236 and 276 people in each group completed the full study period. The reported data shows that, compared to where each group started, lung function (FEV1) one hour after the morning dose increased by 0.247 litres in the higher-dose combination group, 0.226 litres in the lower-dose combination group, 0.165 litres in the formoterol-alone group, and 0.139 litres in the aclidinium-alone group. The placebo group showed a small decline of 0.037 litres. For the "trough" measurement (the lowest lung function reading before the next morning dose), the reported increases were 0.095 litres, 0.076 litres, 0.066 litres, and 0.050 litres for the four active treatment groups respectively, compared to a decline of 0.035 litres in the placebo group. The reported data also shows changes in breathlessness scores and overall respiratory health scores. The breathlessness scale used runs from −9 (major worsening) to +9 (major improvement), and the reported changes were +2.02, +1.98, +1.56, and +1.52 for the four active groups, versus +0.58 for placebo. For the respiratory health questionnaire (where lower scores indicate better health status out of 100), all groups showed a decline (improvement) in score: −6.57, −5.94, −6.44, and −4.70 for the active groups, and −2.22 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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NCT01462942 · results posted 15 February 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,729 people across five groups. Participants received one of four active inhaled medicines — two different combination inhalers (aclidinium/formoterol at two different doses), or one of the two medicines on its own (aclidinium or formoterol alone) — or a placebo (a dummy inhaler with no active medicine). The trial was measuring changes in lung airflow, breathlessness, and quality of life over the study period. Of those who started, between 160 and 351 people in each group completed the trial. The reported data shows that the main measurement was FEV1 — a standard test of how much air a person can breathe out forcefully in one second, recorded in litres. Two timepoints were measured: one hour after taking the morning dose, and just before the next morning dose (called the "trough"). For the one-hour post-dose reading, the placebo group's score changed by −0.030 litres from their starting point, while the combination inhaler groups changed by +0.269 and +0.213 litres, and the single-medicine groups by +0.144 and +0.129 litres. For the pre-dose trough reading, the placebo group changed by −0.061 litres, the combination groups by +0.083 and +0.050 litres, and the single-medicine groups by +0.056 and −0.002 litres. The reported data also shows results for two secondary measures. Breathlessness was rated on a scale from −9 (major worsening) to +9 (major improvement), with a change of 1 unit considered meaningful; scores reported were 1.2 for placebo, 2.5 and 2.4 for the two combination groups, and 2.1 and 2.1 for the single-medicine groups. A quality-of-life questionnaire (scored 0–100, where lower is better and a change of 4 units is considered meaningful) showed changes of −6.5 for placebo, −7.2 and −8.3 for the combination groups, and −5.8 and −5.6 for the single-medicine 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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NCT01970878 · results posted 6 February 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 892 people across four treatment groups: GFF MDI (290 participants), GP MDI (218), FF MDI (213), and an open-label Spiriva Handihaler group (171). The trial ran for 52 weeks and was primarily measuring changes in a lung function test called FEV1 — which measures how much air a person can forcefully breathe out in one second — taken in the morning before any medication dose. The trial also looked at several secondary measures, including breathlessness scores, quality of life, and use of a rescue inhaler (Ventolin). The reported data shows that, on average over the 52 weeks, all four groups showed an increase from their starting FEV1 levels. The GFF MDI group had the largest reported average increase (0.133 litres), followed by Spiriva Handihaler (0.107 litres), GP MDI (0.076 litres), and FF MDI (0.068 litres). For the breathlessness score (rated on a scale where higher numbers mean less breathlessness compared to the start), all groups showed small positive average changes ranging from 0.3 to 0.5 points. On a quality-of-life questionnaire scored from 0 to 100 (where lower scores are better), all groups showed small average reductions from their starting scores, ranging from −1.9 to −3.3 points. For the peak lung function measure within two hours of dosing, reported average increases ranged from 0.234 to 0.363 litres across the groups. The reported data also shows that average daily puffs of rescue Ventolin decreased across all groups, ranging from −0.4 to −0.9 puffs per day compared to the start. 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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NCT01349803 · results posted 31 January 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01349803) enrolled 237 adults with moderate to severe chronic obstructive pulmonary disease (COPD — a long-term lung condition that makes breathing difficult). Participants were divided into four groups and given one of four inhaled medicines: FF MDI (PT005), GP MDI (PT001), GFF MDI (PT003), or Foradil Aerolizer. Each group had around 57–60 people who started the study, and most completed it over 14 days. The trial was primarily measuring whether these medicines changed participants' heart rate over a 24-hour period, and also looked at a breathing measurement called FEV1 (essentially how much air a person can forcefully breathe out in one second). The reported data shows that, for the main measurement — the change in average heart rate over 24 hours after 14 days of dosing — the numbers were very small across all four groups. The FF MDI group showed a change of −0.19 beats per minute (bpm), the GP MDI group −1.84 bpm, the GFF MDI group +0.40 bpm, and the Foradil Aerolizer group −0.09 bpm. Regarding the breathing measurement (FEV1), the reported changes from the starting point were: FF MDI +0.091 litres, GP MDI +0.126 litres, GFF MDI +0.251 litres, and Foradil Aerolizer +0.124 litres. Additional heart rate measurements — including daytime, night-time, and maximum 24-hour heart rate — were also recorded across both Day 1 and Day 14, with the reported changes generally remaining small and varying in direction between 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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NCT01448850 · results posted 30 January 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 324 adults with chronic obstructive pulmonary disease (COPD) — a lung condition that makes it hard to breathe. Of these, 164 were assigned to receive a dummy treatment (placebo) and 160 received the study drug, MEDI8968, given by drip (intravenously) and then by injection under the skin. The trial was mainly measuring how often participants had moderate or severe "flare-ups" — episodes where COPD symptoms got significantly worse, needing antibiotics, steroids, or a hospital stay. By the end of the study, 130 people in the placebo group and 120 in the MEDI8968 group had completed the trial. The reported data shows that for the main measurement — the average number of moderate or severe flare-ups per year — the placebo group had a rate of 0.78 events per year, while the MEDI8968 group had a rate of 0.71 events per year. For flare-ups serious enough to require hospitalisation, the reported rates were 0.14 per year in the placebo group and 0.10 per year in the MEDI8968 group. The data for "time to first flare-up" was not reported in the submitted results. The reported data also shows results from a quality-of-life questionnaire (scored 0–100, where higher scores mean poorer health). Both groups showed small reductions (improvements) in their total scores from the start of the study to week 53 — a change of about −2.76 points in the placebo group and −2.22 points in the MEDI8968 group. Around 45% of placebo participants and 43% of MEDI8968 participants showed at least a 4-point improvement in that score. A separate measure of overall COPD severity (the BODE score, ranging from 0 to 10) showed a small reduction of −0.27 in the placebo group and −0.08 in the MEDI8968 group by week 53. 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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NCT02085161 · results posted 6 January 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 304 people in total, with 76 participants in each of four groups. All four groups received a behavioural modification (lifestyle counselling) program, but each group also received a different inhaled treatment: a placebo (dummy) inhaler, a medicine called tiotropium alone, a combination of tiotropium and olodaterol, or the same combination medicine plus a structured exercise training program. The trial was primarily looking at how long participants could keep walking during a set walking test after 8 weeks. Several secondary measures were also recorded, including walking time and intensity tracked by an activity monitor over a week, a questionnaire about how easily participants could perform everyday activities, the same walking test repeated at 12 weeks, and a lung function measurement. The reported data shows that for the main outcome — how long participants could walk in the timed walking test at 8 weeks — the placebo group averaged around 244 seconds, the tiotropium-only group averaged around 254 seconds, the combination medicine group averaged around 315 seconds, and the combination medicine plus exercise training group averaged around 356 seconds. At 12 weeks, the reported walking test times were similar in pattern: approximately 243 seconds for placebo, 256 seconds for tiotropium alone, 303 seconds for the combination medicine, and 324 seconds for the combination medicine with exercise training. The lung function measurement (how much air participants could breathe out in one second) at 8 weeks was reported as 1.38 litres for placebo, 1.55 litres for tiotropium, 1.73 litres for the combination medicine, and 1.71 litres for the combination medicine with exercise training. The reported data shows that average daily walking time tracked by the activity monitor in the week before the 12-week mark ranged from around 4,146 seconds per day (tiotropium group) to around 4,832 seconds per day (combination medicine group), with the placebo and exercise training groups falling in between at roughly 4,671 and 4,339 seconds respectively. The movement intensity during daily walking was reported as 0.20 in the same units across all four groups. On the everyday activities questionnaire (scored from 0 to 3, where higher means performing more activities with greater ease), scores ranged from about 2.19 in the placebo group to about 2.34 in the combination medicine group, with the other two groups scoring in between. 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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NCT00457951 · results posted 16 December 2016

According to the results reported on ClinicalTrials.gov, this trial involved three groups of participants. Thirteen people took part in an open-label group (meaning both they and their doctors knew what they were receiving), 66 people were in a placebo group (receiving a saline solution with no active ingredient), and 72 people were in the ODSH treatment group. Not everyone completed the study — 16 people in the placebo group and 12 in the ODSH group did not finish. The trial was looking at a condition called COPD (a lung disease that makes breathing difficult) and was measuring something called "treatment failure," which meant either not being well enough to be discharged from hospital using standard medical criteria, or being discharged but then needing to return. The reported data shows that in the placebo (saline) group, 24.6% of participants were recorded as experiencing treatment failure. In the ODSH group, the reported figure was 32.4%. No other outcome measures appear to have been submitted to ClinicalTrials.gov for this trial, so further details on secondary results are not available to report 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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NCT01049360 · results posted 9 November 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01049360) enrolled 125 participants across 20 groups, who each took part in up to four treatment periods. This was a "crossover" trial — meaning each participant tried more than one treatment in a set order — comparing two combination inhalers (aclidinium combined with either a higher or lower dose of formoterol), each ingredient on its own, and a dummy (placebo) inhaler. The main thing the trial was measuring was how much air participants could breathe out in one second — a common lung function test called FEV1 — averaged over a 12-hour window after taking the inhaler. The reported data shows the following changes from each participant's starting (baseline) FEV1, in litres, for the main measure (average over 12 hours): the higher-dose combination inhaler was associated with a reported change of +0.187 litres; the lower-dose combination, +0.189 litres; aclidinium alone, +0.144 litres; formoterol alone, +0.114 litres; and the placebo, −0.013 litres. For the secondary measures, the reported data shows similar patterns: when looking at the FEV1 recorded before the morning dose, the reported changes were +0.124, +0.129, +0.080, +0.071, and −0.008 litres respectively across the same five groups. When looking at the highest FEV1 reading in the morning, the reported figures were +0.355, +0.348, +0.260, +0.245, and +0.073 litres for the same five groups in the same order. 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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NCT00559273 · results posted 1 November 2016

According to the results reported on ClinicalTrials.gov, this trial compared two medicines — Mircera and Darbepoetin Alfa — used to treat anaemia (low red blood cell levels) in people with chronic kidney disease who were not on dialysis. A total of 153 people were assigned to the Mircera group and 154 to the Darbepoetin Alfa group at the start. The trial ran in two stages: a 20-week correction period followed by an 8-week evaluation period. The main things being measured were how many participants' haemoglobin levels (a measure of red blood cells in the blood) rose by a meaningful amount, and by how much those levels changed overall. The reported data shows that in the primary outcomes, approximately 94% of participants in the Mircera group and approximately 94% in the Darbepoetin Alfa group met the haemoglobin response target (a rise of at least 1.0 g/dL above their starting level, reaching at least 10.0 g/dL, without needing a blood transfusion beforehand). The average rise in haemoglobin from the starting point to the evaluation period was reported as 1.66 g/dL for Mircera and 1.69 g/dL for Darbepoetin Alfa. For the secondary outcomes, the reported data shows the median time taken to first reach the response target was 43 days for Mircera and 29 days for Darbepoetin Alfa. The percentage of participants who received a red blood cell transfusion during the trial was reported as 3.3% for Mircera and 6.5% for Darbepoetin Alfa. Additionally, 25.8% of the Mircera group and 47.7% of the Darbepoetin Alfa group had at least one haemoglobin reading above 12.0 g/dL during the first eight weeks. 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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NCT01473758 · results posted 24 October 2016

According to the results reported on ClinicalTrials.gov, this trial looked at whether roflumilast (a tablet taken at a dose of 500 micrograms) compared to a placebo (a dummy tablet with no active ingredient) had any effect on inflammation in the airways of people experiencing a flare-up of a lung condition. The main thing being measured was the number of a type of inflammatory cell — called a neutrophil — in a sample of mucus coughed up by participants, taken 14 days after a flare-up began. In the first phase of the trial, 38 people received roflumilast and 43 received placebo. A smaller second phase involved 10 people on roflumilast and 4 on placebo. Not all participants completed the trial — 11 people in the roflumilast group and 3 in the placebo group did not finish the first phase. The reported data shows that both groups — those on roflumilast and those on placebo — had reductions in their sputum neutrophil counts after 14 days. Using one method of analysis, the roflumilast group showed a reduction of about 18.7 units and the placebo group showed a reduction of about 20.1 units. Using a second method of analysis, the roflumilast group showed a reduction of about 19.6 units and the placebo group showed about 19.2 units. For a secondary measure — looking at how many participants' neutrophil counts returned to their usual stable level by day 14 — the reported data shows this occurred in approximately 37.5% to 45% of the roflumilast group and approximately 51.6% to 55.2% of the placebo group, depending on the analysis method used. Similar patterns of reduction in total cell counts in sputum were reported across multiple 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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NCT01601977 · results posted 18 August 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 participants, and all 10 completed the study. The trial was comparing two breathing support devices used overnight — an intervention device and the participant's usual care device — in people who experience a build-up of carbon dioxide in their blood during sleep (a condition called nocturnal hypoventilation). The main thing being measured was the level of carbon dioxide in the blood overnight, recorded through a sensor on the skin. Secondary measurements included quality of life, total sleep time, and how far participants could walk in six minutes. The reported data shows that for the primary measure — overnight carbon dioxide levels recorded via a skin sensor — participants using the intervention device recorded an average of 6.5 kPa (kilopascals, a unit of pressure used to measure gas levels in the blood), compared to 6.7 kPa with the usual care device. For the secondary carbon dioxide measure (a slightly different way of calculating the average), the reported figures were 6.4 kPa for the intervention and 6.5 kPa for usual care. On the quality of life questionnaire (scored from 0 to 100, where higher means better), both groups scored similarly — around 60–61 for the intervention and 59 for usual care. Total sleep time was reported as 330 minutes with the intervention device and 306 minutes with the usual care device. The six-minute walk test (a measure of how far someone can walk in six minutes) showed 190 metres for the intervention group and 175 metres for the usual 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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NCT01313676 · results posted 9 August 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 16,568 people with COPD (a lung condition), split roughly equally across four groups: one group received a placebo (dummy treatment with no active ingredient), one received a medicine called fluticasone furoate on its own, one received a medicine called vilanterol on its own, and one received both medicines combined. The trial was primarily measuring how many people died from any cause over the study period, and also looked at how quickly lung function declined over time and how many people experienced serious heart-related events. The reported data shows that, out of those included in the main analysis, deaths from any cause numbered 275 in the placebo group, 251 in the fluticasone furoate group, 265 in the vilanterol group, and 246 in the combined medicine group. For lung function — measured by how much air a person can breathe out forcefully in one second — the reported rate of annual decline was minus 46 millilitres per year in the placebo group, minus 38 in the fluticasone furoate group, minus 47 in the vilanterol group, and minus 38 in the combined medicine group. Regarding serious heart-related events (such as heart attack or stroke), the number of participants who experienced at least one such event was 173 in the placebo group, 161 in the fluticasone furoate group, 180 in the vilanterol group, and 174 in the combined medicine 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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NCT00626522 · results posted 8 August 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 566 people in total across six groups. Participants were given one of three different combination doses of two inhaled medicines — aclidinium and formoterol — or aclidinium alone, formoterol alone, or a placebo (an inactive dummy treatment). The trial was measuring changes in lung airflow, specifically using a breathing test called FEV1 (the amount of air a person can breathe out forcefully in one second), to see how the different treatments compared over the course of a treatment period. The reported data shows that for the main (primary) measure — average change in FEV1 airflow over a 12-hour period compared to the start of the trial — all active treatment groups showed an increase in litres of air exhaled, while the placebo group showed a small decrease of 0.036 litres. The three combination groups recorded changes of +0.170, +0.219, and +0.230 litres respectively; the aclidinium-alone group recorded +0.075 litres; and the formoterol-alone group recorded +0.099 litres. The reported data for the secondary measures — including peak airflow (the single best reading), early airflow over three and six hours, and trough airflow (the lowest reading, taken just before the next dose) — followed a broadly similar pattern across the groups, with the combination groups generally recording higher numbers than the single-medicine or 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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NCT02366637 · results posted 6 July 2016

According to the results reported on ClinicalTrials.gov, this was a small crossover trial — meaning participants took both the active treatment and a placebo at different times, with a washout period in between. A total of 13 people were enrolled (7 starting in the active treatment group receiving PF-03715455 680 micrograms twice daily, and 6 starting in the placebo group). The trial was primarily measuring changes in lung function, specifically a breathing test called FEV1 — the amount of air a person can forcibly breathe out in one second — as well as broader measures of airflow capacity (FVC) and markers of airway inflammation in mucus samples. The reported data shows that at the start of the trial, the average FEV1 was 1.368 litres in the active treatment group and 1.456 litres in the placebo group. After four weeks, the active treatment group's FEV1 changed by minus 0.047 litres (a small decrease from their starting point), while the placebo group's FEV1 changed by plus 0.080 litres (a small increase). Similar small numerical differences between the two groups were also reported at weeks one and three, and for the broader airflow measure (FVC). It is also worth noting that only 1 participant in each group completed both treatment periods of the trial, which means very few people contributed data to the final results. Importantly, the reported data shows no measurements were recorded for the sputum (mucus) cell count outcomes or for the blood concentration measures of the study drug — those results were 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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NCT01679314 · results posted 9 May 2016

According to the results reported on ClinicalTrials.gov, this trial involved 54 people in total — 26 were assigned to use the active AlphaCore device and 28 used a sham (inactive/dummy) version of the same device. The trial was measuring several things in people with chronic obstructive pulmonary disease (COPD), including quality of life and symptom scores, breathlessness during physical activity, how far participants could walk in six minutes, a measure of lung airflow, and a general health quality-of-life questionnaire. The main (primary) outcome was a standard COPD symptom and quality-of-life questionnaire called the CAT score, measured over eight weeks. The reported data shows that on the CAT score (where lower numbers mean fewer reported symptoms, on a scale of 0–5 per question), the active device group's average score changed by −1.3 points from their starting point, while the sham device group changed by −0.9 points — meaning both groups reported some reduction in scores over the study period. For the breathlessness-during-activity measure (Borg scale, 0–11), the reported change was 0.7 for the active group and 0.4 for the sham group. For the six-minute walking test, the active group's average distance changed by 8.1 metres and the sham group's by 12.6 metres. The lung airflow measure (FEV1, which looks at how much air someone can breathe out in one second) showed reported values of around 30.7–31.0% of the predicted value for both groups, with little difference between them. The reported data also shows that 10 participants in the active device group and 6 in the sham group had adverse events (unexpected or unwanted experiences) recorded during 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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NCT01680991 · results posted 25 April 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01680991) looked at how the drug obinutuzumab (at a dose of 1,000 mg) behaved in the body across three groups of blood cancer patients: 12 people with chronic lymphocytic leukaemia (CLL), 23 people with a type of lymphoma called diffuse large B-cell lymphoma (DLBCL), and 13 people with another lymphoma type called follicular lymphoma (FL) — 48 participants in total. The trial was primarily measuring how much of the drug was present in the blood over time, and what the highest blood concentration reached was, at two different points during treatment (early on in cycle 1, and later at cycle 8). The reported data shows that in the early part of treatment (cycle 1, day 1), the total amount of drug measured in the blood over the first seven days — a figure called "area under the curve" or AUC, which gives a picture of overall drug exposure — was 1,458 units for the CLL group, 1,750 for the DLBCL group, and 1,647 for the FL group (measured in day×micrograms per millilitre). The peak blood level of the drug at that same early point was reported as 369 micrograms per millilitre for CLL, 442 for DLBCL, and 437 for FL. By cycle 8, the total drug exposure over a 21-day window had increased considerably across all groups (12,289, 13,000, and 11,285 units respectively), and the peak blood levels at cycle 8 were reported as 1,050, 966, and 867 micrograms per millilitre. The reported data also shows how quickly the drug reached its peak level in the blood at cycle 8: approximately 3.5 hours for the CLL group, 7.25 hours for DLBCL, and 4.0 hours for FL. The time it took for the drug's blood concentration to fall by half — known as its "half-life" — was reported as approximately 21.5 days for CLL, 33.3 days for DLBCL, and 26.7 days for FL. 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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NCT01701245 · results posted 25 April 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01701245) looked at a device called GammaCore — a handheld device that delivers a gentle electrical pulse to the neck — compared to standard medical care alone, for people experiencing cluster headaches (an intense type of recurring headache). A total of 49 people were assigned to the standard care group and 48 to the GammaCore group at the start, though not all participants completed the trial (37 and 33 respectively finished in each group). The reported data shows that the main thing being measured was the change in how many cluster headache attacks participants had per week, comparing a two-week lead-in period to the last two weeks of treatment. The standard care group reported an average reduction of 2.0 attacks per week, while the GammaCore group reported an average reduction of 7.6 attacks per week. For a secondary measure looking at self-reported pain levels (on a scale of 0 = no pain to 4 = very severe pain), the trial also tracked how participants' pain ratings shifted over the study period, with results spread across the different pain categories for both groups — the full breakdown by category was recorded but a single summary figure was not reported in the data provided. On a quality-of-life questionnaire (EQ-5D-3L, which rates everyday health across five areas, with lower scores meaning more problems), the reported change for the standard care group was −0.049 and for the GammaCore group was +0.145 during the treatment period. On the accompanying wellbeing scale (rated 0–100, where 100 is the best imaginable health), the standard care group reported a change of +0.27 and the GammaCore group reported a change of +9.20 during the same period. Adverse events (unwanted effects noted during the study) were recorded for 6 participants in the standard care group and 9 in the GammaCore group, with additional subcategories also 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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NCT01682863 · results posted 30 March 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 615 people in total across three groups. Each group received a different inhaled medication — two groups received a combination medicine called QVA149 (at two different dose strengths, taken twice daily), and one group received a single medicine called QAB149 (taken once daily). The trial was measuring things like unwanted health events that occurred during the study, how long people stayed on their treatment, and changes in lung function over time. Roughly 177 to 187 people in each group completed the study. The reported data shows that when it came to the primary focus — tracking unwanted health events — 139 participants in the lower-dose QVA149 group, 142 in the higher-dose QVA149 group, and 139 in the QAB149 group experienced at least one adverse event (an unwanted health occurrence during the study). Serious adverse events were reported in 26, 25, and 24 participants respectively across the three groups, and deaths during the study were reported for 1, 3, and 5 participants respectively. For lung function, the reported data shows that all three groups had increases from their starting measurements in how much air they could breathe out (measured in litres), with the higher-dose QVA149 group generally recording the largest increases across the different time points measured. The percentage of participants who experienced a moderate or severe flare-up of their lung condition was reported as 23.5%, 24.9%, and 27.0% across the three groups. For time to stopping treatment early, a full median figure was only calculable for the lower-dose QVA149 group (reported as 384 days); the data was not reported in a way that produced a calculable figure for the other 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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NCT02257385 · results posted 3 March 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT02257385) enrolled 961 adults in total — 482 in one group and 479 in the other. One group took a combination inhaler called umeclidinium/vilanterol (62.5/25 micrograms), while the other group took two separate inhaled medicines together: indacaterol (150 micrograms) and tiotropium bromide (18 micrograms). The trial ran for approximately 12 weeks and was primarily measuring lung function — specifically how much air participants could forcefully breathe out in one second, a test known as FEV1. Around 460 and 457 people respectively completed the study, with 22 in each group not finishing. The reported data shows that the main outcome measured was the change in lung function from the start of the trial to around Day 85 (roughly 12 weeks in), assessed in the morning before that day's dose. The umeclidinium/vilanterol group showed an average increase of 0.172 litres of air exhaled, while the indacaterol plus tiotropium group showed an average increase of 0.171 litres — these figures were very close to one another. A secondary outcome looked at lung function over the six hours following a dose on Day 84. The reported data shows the umeclidinium/vilanterol group averaged an increase of 0.235 litres, while the indacaterol plus tiotropium group averaged an increase of 0.258 litres over that same window. It is worth noting that these numbers describe averages across large groups of participants, and no information about side effects or safety was included in the structured 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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NCT02125734 · results posted 20 January 2016

According to the results reported on ClinicalTrials.gov, this trial involved 88 participants in total — 40 in one treatment sequence group and 48 in the other. It was a crossover study, meaning participants tried both treatments (QVA149 and Tiotropium) in different periods. The trial was measuring lung function and treatment preference after people had experienced both inhaled medications. Almost all participants completed both periods, with only one person not finishing the second period. The reported data shows that for the primary outcome — the amount of air a person could forcibly breathe out in one second (measured one hour after inhaling the medication, using a device called a spirometer) — the average figure was 1.676 litres for QVA149 and 1.595 litres for Tiotropium. For the secondary outcomes, participants were asked which treatment they preferred after trying both: 59 out of 85 who responded said they preferred QVA149, while 26 said they preferred Tiotropium. The reported data also shows that when investigators (the treating clinicians in the trial) were asked which treatment they would suggest for future use for each patient, 71 indicated QVA149 and 16 indicated Tiotropium. It is worth noting that the preference questionnaire figures add up to 85 and 87 respectively, which is slightly fewer than the total enrolled, suggesting not all participants' responses were captured for those questions — the data does not explain this gap 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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NCT02006732 · results posted 20 January 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 809 adults across four groups: one group received a placebo (an inactive treatment), one received tiotropium 5 μg alone, one received a combination of tiotropium 2.5 μg and olodaterol 5 μg, and one received a combination of tiotropium 5 μg and olodaterol 5 μg. The trial was measuring lung function, quality of life related to breathing, and breathlessness. Of the 809 people who started, 764 completed the study — the placebo group had the highest number of people who did not finish (20 out of 202), while the tiotropium 5 μg plus olodaterol 5 μg group had the fewest drop-outs (4 out of 202). The reported data shows that one key lung function measure — how much air participants could breathe out in one second over a three-hour period after taking their dose — changed from baseline (their starting point) by −0.006 litres in the placebo group, +0.188 litres in the tiotropium-only group, +0.279 litres in the lower-dose combination group, and +0.293 litres in the higher-dose combination group. A similar pattern was reported for lung function measured at the end of a full 24-hour dosing period, where changes from baseline were −0.003, +0.124, +0.166, and +0.163 litres respectively. For quality of life (scored 0–100, where lower means less impact on daily life), the reported scores were 42.6 for placebo, 39.7 for tiotropium alone, 38.9 for the lower-dose combination, and 38.0 for the higher-dose combination. When this quality-of-life data was combined with a separate companion trial, the scores were 42.3, 39.7, 38.4, and 37.6 respectively. The reported data also shows results for two secondary measures. For the total amount of air breathable in one breath at the 24-hour mark, changes from baseline were −0.021 litres (placebo), +0.170, +0.284, and +0.231 litres across the three active groups. For breathlessness (scored from −9 worst to +9 best), the reported scores were 0.337 (placebo), 0.950, 1.599, and 1.531 across the active 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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NCT00547456 · results posted 16 December 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom completed the study with no drop-outs. The trial was investigating whether providing extra oxygen during sleep (nocturnal oxygen supplementation) would show improvement in three areas for people who experience a drop in their oxygen levels while sleeping: body-wide inflammation (the body's internal response processes), sleep quality, and overall health-related quality of life. The reported data shows that while the primary outcome measure was listed — looking at improvements in systemic inflammation, sleep quality, and health-related quality of life — no numerical results or measurements were actually provided in the data submitted to ClinicalTrials.gov. This means the specific figures for these outcomes were not reported, and 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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NCT01329029 · results posted 29 October 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 973 people in the roflumilast group and 972 people in the placebo (dummy tablet) group — just under 1,945 participants in total. The trial was looking at people with a lung condition called COPD, and its main goal was to measure how often participants experienced "flare-ups" (called exacerbations) — episodes where breathing symptoms became noticeably worse and needed medical attention. Flare-ups were classed as "moderate" (needing steroid tablets or injections) or "severe" (requiring a hospital stay or leading to death). The trial also measured a breathing test called FEV1, which records how much air a person can forcefully breathe out in one second. The reported data shows that, on average, people in the roflumilast group had approximately 0.81 moderate-or-severe flare-ups per person per year, compared with approximately 0.93 in the placebo group. For severe flare-ups alone (those requiring hospitalisation or leading to death), the reported figures were around 0.24 per person per year in the roflumilast group versus 0.32 in the placebo group. Regarding the proportion of people who had at least one flare-up of any kind during the trial, the reported data shows 55.2% in the roflumilast group and 60.5% in the placebo group. The median time (the midpoint — half of participants had their first flare-up before this, half after) to a first flare-up of any type was reported as 218 days in the roflumilast group and 180 days in the placebo group. For the breathing test, the roflumilast group showed an average change of +0.052 litres from their starting measurement, while the placebo group showed an average change of −0.004 litres. It is worth noting that more participants in the roflumilast group (269 out of 973) did not complete the trial compared with the placebo group (192 out of 972), which the reported data does not fully explain. 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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NCT01578707 · results posted 12 October 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01578707) enrolled 391 people — 196 in the ofatumumab group (Arm A) and 195 in the ibrutinib group (Arm B). All participants were accounted for at the end of the study. The trial was primarily measuring how long people went without their disease getting worse (called "progression-free survival"), comparing the two treatments in people with a type of blood cancer called chronic lymphocytic leukaemia (CLL). The reported data shows that for the primary measure — time without disease worsening, assessed by an independent review committee at a set analysis point in November 2013 — the ofatumumab group had a median of 8.1 months. For the ibrutinib group, this figure was recorded as "NA" (not available/not reached at that time), meaning the median had not yet been reached when the analysis was done. In a longer-term follow-up measure assessed by the treating doctors (up to six years), the reported median was 8.1 months for ofatumumab and 44.1 months for ibrutinib. For overall survival (how long people lived), the reported medians were 65.1 months for ofatumumab and 67.7 months for ibrutinib — noting that many participants in the ofatumumab group crossed over to ibrutinib during the study, which the researchers acknowledged was not adjusted for in that analysis. The reported data also shows that the proportion of participants whose disease responded to treatment (overall response rate) was 4.1% for ofatumumab and 42.6% for ibrutinib based on the independent review, and 22.4% versus 87.7% respectively based on the treating doctors' longer-term assessment. For blood count improvements (haemoglobin levels rising meaningfully), 32.6% of the ofatumumab group and 69.7% of the ibrutinib group met that measure; for platelet improvements, the figures were 9.4% and 78.4% 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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NCT01431274 · results posted 16 July 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 2,624 people across five treatment groups. Each group received a different inhaled medication or combination: olodaterol alone (5 µg), tiotropium alone at one of two doses (2.5 µg or 5 µg), or a fixed-dose combination of tiotropium and olodaterol at two different dose levels (2.5/5 µg or 5/5 µg). The trial was measuring lung function — specifically how much air participants could breathe out in one second (known as FEV1) — as well as participants' own ratings of their respiratory health and breathlessness, over roughly 24 weeks. Between 431 and 466 people in each group completed the trial. The reported data shows that, for the main lung function measure at around 24 weeks (Day 169), the average improvement in FEV1 over the first three hours after a dose was 0.133 litres for the olodaterol-alone group, 0.148 litres for tiotropium 2.5 µg, 0.139 litres for tiotropium 5 µg, 0.241 litres for the lower-dose combination, and 0.256 litres for the higher-dose combination — all compared to each participant's own starting (baseline) measurement. For the "trough" FEV1 (a measure of lung function at the end of a full 24-hour dosing period, on Day 170), the reported figures were 0.054, 0.083, 0.065, 0.111, and 0.136 litres respectively for the same five groups. The trial also used a respiratory quality-of-life questionnaire (scored 0–100, where lower is better); reported total scores at Day 169 ranged from approximately 36.7 to 38.4 across the groups. A breathlessness questionnaire (scored –9 to +9, where higher is better) showed reported scores ranging from about 1.6 to 2.0 across the groups at the same time point. The reported data shows similar patterns at the earlier measurement points (Day 1 and Day 85), with the FEV1 improvements over three hours ranging from approximately 0.148 to 0.237 litres on Day 1, and from 0.161 to 0.289 litres on Day 85, across the five groups. These numbers represent averages across each group and were adjusted using a statistical modelling approach to account for differences between 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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NCT00975195 · results posted 10 February 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 2,488 people with COPD (a long-term lung condition), split evenly into two groups of 1,244. One group continued taking a fluticasone-based inhaler (the "maintenance" group), while the other group had fluticasone gradually withdrawn from their treatment (the "withdrawal" group). The trial was mainly measuring how long it took before a patient had their first moderate or severe COPD flare-up — a worsening of symptoms serious enough to need new or changed treatment, such as antibiotics, steroids, or a hospital visit. The reported data shows that, for the primary measure — time to first moderate or severe flare-up — the milestone used was the point by which 25% of patients in each group had experienced their first flare-up. That point was reached at 107 days in the maintenance group and 110 days in the withdrawal group. For the secondary measures, the adjusted average rate of moderate or severe flare-ups was reported as 0.91 per patient per year in the maintenance group and 0.95 in the withdrawal group. Around 44% of the maintenance group and 47% of the withdrawal group experienced at least one moderate or severe flare-up during the study. Looking specifically at severe flare-ups alone, the reported rate was 0.20 per patient per year in the maintenance group and 0.23 in the withdrawal group, and approximately 13% versus 15% of patients in each group respectively had at least one severe flare-up. For the time-to-first *severe* flare-up measure, the reported data shows a figure of 419 days for the withdrawal group, but no equivalent figure was reported for the maintenance group — likely because fewer than 25% of that group reached that milestone during the study period, meaning the data was not available to report. 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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NCT01513460 · results posted 5 January 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01513460) enrolled 773 adults across three treatment groups: one group received NVA237 (a type of inhaled bronchodilator) combined with fluticasone/salmeterol (a common inhaled combination preventer, referred to as Flu/Sal); a second group received tiotropium (another bronchodilator) combined with Flu/Sal; and a third group received Flu/Sal alone. The trial was primarily measuring changes in lung airflow — specifically a breathing test called FEV1 (how much air a person can forcefully breathe out in one second) — at a set point near the end of a dosing cycle, known as "trough" FEV1. The study ran for 12 weeks and also looked at quality-of-life scores, use of reliever ("rescue") medication, and nighttime awakenings due to symptoms. The reported data shows that, for the primary outcome comparing NVA237 + Flu/Sal against tiotropium + Flu/Sal, both groups showed a small increase in trough FEV1 from their starting point — an average change of +0.095 litres in the NVA237 + Flu/Sal group and +0.102 litres in the tiotropium + Flu/Sal group. For the secondary outcomes comparing these two combined groups against Flu/Sal alone, the reported data shows the Flu/Sal-only group had a very small decrease from baseline (around −0.010 to −0.012 litres depending on the time point), while the two combined groups showed increases in the range of +0.077 to +0.092 litres. On the quality-of-life questionnaire (scored 0–100, where lower is better), scores changed by −2.8, −3.9, and −0.7 points for the NVA237 + Flu/Sal, tiotropium + Flu/Sal, and Flu/Sal-only groups respectively. The reported data also shows average daily rescue inhaler use of approximately 2.2, 2.1, and 2.9 puffs per day across the three groups, and the percentage of nights without symptom-related awakenings was reported as roughly 83%, 82%, and 82% 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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NCT01006616 · results posted 17 November 2014

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called navarixin in people with chronic obstructive pulmonary disease (COPD), a lung condition that makes it hard to breathe. The trial compared three different doses of navarixin (10 mg, 30 mg, and 50 mg) against a placebo (a dummy treatment with no active ingredient). Around 616 people started the first phase of the trial, split roughly equally across the four groups. The main things being measured were changes in lung function — specifically how much air someone can forcefully breathe out in one second (called FEV1) — and whether participants experienced a drop in a type of white blood cell (neutrophils) that can affect the immune system. The reported data shows that after about six months, changes in lung function (FEV1) from the starting point were small across all groups: the 10 mg navarixin group showed a change of −0.009 litres, the 30 mg group −0.068 litres, the 50 mg group +0.028 litres, and the placebo group −0.039 litres. Regarding the white blood cell measure, the percentage of participants who experienced an adverse event (an unwanted medical occurrence) related to low neutrophil counts during the first six months was 3.3% in the 10 mg group, 12.8% in the 30 mg group, 20.4% in the 50 mg group, and 0.6% in the placebo group. For the longer follow-up periods and the second phase of the trial, those figures were listed as not available in the reported data. On the secondary measures, the reported data shows that the proportion of participants who had at least one moderate-to-severe COPD flare-up (a worsening of symptoms) over the first six months ranged from about 26% to 32% across the groups, and over the first year ranged from about 33% to 37%. Results for the patient questionnaire about symptom experience were not reported in the 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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NCT01636076 · results posted 17 November 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 629 people with a breathing condition (316 in one group and 313 in the other). Participants were assigned to receive either an inhaled combination medicine called QMF149 or a comparator combination inhaler called Salmeterol Xinafoate/Fluticasone Propionate (a commonly used treatment for conditions like asthma or COPD). The trial ran for approximately 12 weeks (85 days) and its main focus was on measuring lung function using a breathing test called FEV1 — this measures how much air a person can forcefully breathe out in one second, recorded in litres. A higher number generally indicates more air being exhaled. By the end of the trial, 299 people in the QMF149 group and 288 in the comparator group had completed it. The reported data shows that the primary outcome — a lung function reading taken roughly 23–24 hours after a dose on Day 85 (called "trough FEV1", meaning the measurement at the point when the medicine's effect would be at its lowest) — was approximately 1.27 litres for the QMF149 group and approximately 1.22 litres for the comparator group. For the secondary outcomes, lung function readings taken at various earlier time points (including after the first dose and after four weeks) were also reported, with values ranging roughly between 1.14 and 1.29 litres across both groups and time points. Additional breathing measurements (FVC, which measures total air breathed out, and the ratio of FEV1 to FVC) were also recorded at multiple points; the reported data shows these figures were broadly similar between the two groups across the timepoints 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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NCT00295061 · results posted 9 September 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 adults who had a condition called alpha-1-antitrypsin (AAT) deficiency — a genetic condition that can affect the lungs and liver. The trial used a "crossover" design, meaning all participants received both treatments being compared (Alpha-1 MP and Prolastin®) at different times, with 12 people starting on each treatment first. All 24 participants completed the trial. The study was measuring how similarly the two treatments behaved in the body — specifically by tracking a value called AUC (area under the curve), which is a way of measuring how much of a substance is present in the blood over a period of time, in this case from Day 0 to Day 7. The reported data shows that the average AUC value for Alpha-1 MP was 155.9 mg\*h/mL, and for Prolastin® it was 152.4 mg\*h/mL. These figures represent the amount of the active protein measured in participants' blood over the seven-day window. The study was designed to assess whether these two numbers were close enough to meet a standard regulatory definition of "bioequivalence" — meaning the two products behave similarly enough in the body to be considered comparable. No other outcome measure results were included 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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NCT01694771 · results posted 4 September 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01694771) enrolled 1,132 people in total — 567 in the group receiving a combination of olodaterol (5 micrograms) and tiotropium (18 micrograms), and 565 in the group receiving a placebo alongside tiotropium (18 micrograms) alone. The vast majority completed the trial: 527 and 525 people respectively. The trial was measuring changes in lung airflow over 12 weeks. The main measurements used were tests of how much air a person can breathe out — specifically a standard breathing test called FEV1 (the amount of air someone can force out in one second) and FVC (the total amount of air someone can force out). These were measured at their lowest point of the day (called "trough"), their highest point (called "peak"), and averaged over a three-hour window after taking the medication. The reported data shows the following changes from the starting point after 12 weeks. For the primary (main) outcomes, the combination group showed an average increase in the three-hour averaged FEV1 breathing score of 0.313 litres, compared with 0.196 litres in the tiotropium-only group. For the lowest daily FEV1 reading, the combination group showed an average increase of 0.195 litres, compared with 0.133 litres in the tiotropium-only group. For the secondary (additional) outcomes, the highest FEV1 reading increased by an average of 0.389 litres in the combination group versus 0.270 litres in the other group. For the FVC breathing measure, the three-hour averaged score rose by 0.438 litres (combination) versus 0.292 litres (tiotropium only); the lowest daily FVC reading rose by 0.276 litres versus 0.213 litres; and the highest FVC reading rose by 0.586 litres versus 0.433 litres. 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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NCT01415518 · results posted 26 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 292 participants in each of two groups — 584 people in total. One group received a combination of Symbicort Turbuhaler (an inhaled medicine containing budesonide and formoterol) together with ipratropium and slow-release theophylline. The other group received ipratropium and slow-release theophylline only, without the Symbicort. The trial was primarily measuring lung function, specifically how well participants could forcefully breathe out air — a test called FEV1 (the amount of air you can blow out in one second). Results were expressed as a ratio comparing each participant's lung function during the treatment period against their starting (baseline) value, so a number above 1.0 means the reading was higher than at the start. The reported data shows that for the main measure (pre-dose FEV1 ratio), the Symbicort combination group recorded a ratio of 1.079, while the group without Symbicort recorded 1.009. For the secondary lung function measures, the Symbicort combination group's FEV1 ratio was 1.179 at 5 minutes after a dose and 1.219 at 60 minutes after a dose; the comparison group recorded 1.106 and 1.142 at those same time points. A similar pattern was seen in another breathing measurement called FVC (how much air you can blow out in total): the Symbicort combination group's pre-dose FVC ratio was 1.072, rising to 1.170 at 5 minutes and 1.192 at 60 minutes after a dose; the comparison group recorded 1.030, 1.120, and 1.148 at those same points. The reported data also shows that 276 out of 290 participants in the Symbicort combination group and 261 out of 292 in the comparison group completed the study, meaning some participants did not finish — though the reasons for not completing were 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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NCT00395083 · results posted 21 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 426 people with COPD (a lung condition) — 217 in a "Usual Care" group and 209 in a "Comprehensive Care Management Program" group. The trial was measuring two main things: how long participants went without being hospitalised for COPD, and whether there were differences in the number of COPD-related hospitalisations between the two groups. It also tracked deaths from any cause over the course of the study. The reported data shows that, for the main outcome of time without a COPD-related hospitalisation, the average was 0.45 years in the Usual Care group and 0.46 years in the Comprehensive Care Management Program group — a very small numerical difference. For COPD-related hospitalisations specifically, 34 people in the Usual Care group and 36 people in the Comprehensive Care Management Program group experienced one. For the secondary outcome of deaths from any cause, the reported data shows 10 deaths in the Usual Care group and 28 deaths in the Comprehensive Care Management Program group. The average time to death from any cause was reported as 0.51 years in the Usual Care group and 0.49 years in the Comprehensive Care Management Program group. It is worth noting that the trial appears to have been stopped early, which may affect how these numbers should be interpreted — your doctor can explain more about that. 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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NCT01040130 · results posted 8 July 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 151 people across six groups, each receiving different sequences of treatments — a placebo (inactive treatment), a 5 microgram dose of olodaterol (Olo 5 mcg), and a 10 microgram dose of olodaterol (Olo 10 mcg) — in varying orders over three treatment periods. The trial was designed as a "crossover" study, meaning every participant received all three treatments at different times, just in a different order. Between 20 and 25 people in each group completed the full study. The main thing being measured was how long participants could keep exercising on a stationary bike at a set level of effort after six weeks on each treatment. The reported data shows that after six weeks, the average exercise endurance time — measured in seconds — was approximately 370 seconds for the placebo group, around 422 seconds for those on the 5 mcg olodaterol dose, and around 421 seconds for those on the 10 mcg dose. For the secondary measures, the reported data shows that a lung capacity measurement called "inspiratory capacity" (how much air a person can breathe in) was slightly higher in both olodaterol groups compared to placebo, at several points during the exercise test. Breathing discomfort, rated on a scale of 0 (nothing at all) to 10 (maximum discomfort) during exercise, was reported as approximately 5.9 for placebo, 5.1 for the 5 mcg dose, and 5.2 for the 10 mcg dose. Before exercise began, discomfort scores were low across all groups (all under 0.3 out of 10). 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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NCT01040689 · results posted 30 June 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 108 people in total, split evenly across four groups of 27. Each group received the treatments in a different order — a placebo, olodaterol at 5 micrograms, olodaterol at 10 micrograms, and tiotropium at 18 micrograms — meaning every participant cycled through all four over the course of the study. By the end, 95 of the 108 participants had completed the trial. The trial was measuring lung function using a test called FEV1 — which captures how much air a person can forcefully breathe out in one second. Specifically, it tracked how FEV1 changed from a starting point (called a "baseline") across different windows of time after each dose. The reported data shows the following changes from baseline in litres of air, averaged across participants. For the main (primary) measures over the first 12 hours after dosing at six weeks: the placebo group showed a small decrease of 0.054 L, while olodaterol 5 mcg showed an increase of 0.131 L, olodaterol 10 mcg an increase of 0.152 L, and tiotropium 0.119 L. Over hours 12–24 at six weeks, the placebo group showed a decrease of 0.095 L, olodaterol 5 mcg an increase of 0.036 L, olodaterol 10 mcg an increase of 0.082 L, and tiotropium 0.027 L. For the secondary measures, similar patterns in the numbers were reported across the full 24-hour period, the first three hours after the first dose, the first three hours after six weeks of treatment, and the single highest FEV1 reading in the first three hours — with the placebo group generally showing little change or a small decrease, and the active treatment groups showing increases ranging roughly from 0.027 L to 0.279 L depending on the time window and 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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NCT00782210 · results posted 30 April 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 624 people across three groups: 209 received a placebo (a dummy treatment with no active ingredient), 208 received a 5 microgram once-daily dose of a medicine called olodaterol, and 207 received a 10 microgram once-daily dose of olodaterol. The trial ran for 12 weeks and was primarily measuring lung function using a test called FEV1 — which records how much air a person can forcefully breathe out in one second. A higher FEV1 generally indicates more airflow. By the end of the study, 159 placebo participants, 173 in the 5 mcg group, and 172 in the 10 mcg group had completed the trial. The reported data shows that the two main (primary) outcomes were measured at 12 weeks. The first looked at average lung airflow over a three-hour window after taking the dose: the placebo group's FEV1 changed by −0.007 litres from their starting point, while the 5 mcg olodaterol group changed by +0.165 litres and the 10 mcg group by +0.169 litres. The second primary measure looked at lung function just before the next day's dose (called "trough FEV1"), capturing how much effect remained after roughly 24 hours: the placebo group showed a change of −0.041 litres, compared with +0.050 litres for the 5 mcg group and +0.060 litres for the 10 mcg group. The reported data also shows that similar patterns in lung airflow measurements were observed on Day 1, after 2 weeks, after 6 weeks, and over a 12-hour post-dose window at 12 weeks, with the olodaterol groups consistently reporting higher values than the placebo group at each of those 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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NCT01772134 · results posted 16 April 2014

According to the results reported on ClinicalTrials.gov, this trial involved 617 people across three groups. All participants were already taking a combination inhaler called fluticasone/salmeterol (FSC), and the trial was testing what happened when an additional inhaled medicine called umeclidinium (UMEC) — at either a lower or higher dose — was added to that existing treatment, compared to adding a dummy (placebo) inhaler instead. The main thing being measured was a lung function test called FEV1, which captures how much air a person can forcefully breathe out in one second. Around 178–190 people in each group completed the full 12-week trial. The reported data shows that, for the main outcome — the change in that breathing measurement at around the 12-week mark — the placebo group's score fell slightly (by 0.022 litres on average), while the two UMEC groups showed increases of 0.125 litres and 0.116 litres respectively. For a related breathing measurement taken over the six hours after a dose at week 12, the reported figures were an increase of 0.032 litres in the placebo group, 0.196 litres in the lower-dose UMEC group, and 0.192 litres in the higher-dose UMEC group. These are average figures across each group; individual results varied. The reported data also shows results for two secondary measures. For the proportion of days participants did not need to use their "rescue" inhaler (a short-acting reliever), the placebo group saw an average increase of 4.9 percentage points over 12 weeks, compared to 13.3 percentage points in the lower-dose UMEC group and 11.1 percentage points in the higher-dose UMEC group. For the average number of puffs of rescue inhaler used per day, all three groups reported a small reduction: 0.2 fewer puffs per day in the placebo group, and 0.5 fewer puffs per day in both UMEC 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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NCT01316913 · results posted 24 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 869 people in total across four groups, all of whom had COPD (a lung condition). The groups were given one of three different inhaled medicines — UMEC alone at 125 micrograms, or two combination doses of UMEC paired with another medicine called VI (at 62.5/25 or 125/25 micrograms) — or a comparator medicine called tiotropium (TIO, 18 micrograms). All medicines were taken once daily. The main thing the trial measured was a lung function test called FEV1, which is the amount of air a person can forcefully breathe out in one second. Numbers of people who completed the trial ranged from 163 to 176 across the four groups, out of the 215–222 who started in each group. The reported data shows that the primary measurement — the change in "trough FEV1" (a lung reading taken roughly 23–24 hours after the previous day's dose, reflecting the medicine's carry-over effect) at around Day 169 — increased from starting levels in all four groups. The reported increases were: 0.186 litres for UMEC 125 µg, 0.208 litres for the lower combination dose, 0.223 litres for the higher combination dose, and 0.149 litres for the tiotropium group. For a secondary measure — average lung function over the six hours after the dose on Day 168 — the reported changes from starting levels were 0.206 litres (UMEC 125 µg), 0.276 litres (lower combination), 0.282 litres (higher combination), and 0.180 litres (tiotropium). The trial also tracked self-reported shortness of breath during daily activities using a questionnaire scored from 1 to 4 (higher scores meaning more breathlessness). The reported changes from starting scores at Week 24 were −0.19 (UMEC 125 µg), −0.29 (lower combination), −0.33 (higher combination), and −0.21 (tiotropium), meaning all groups reported some reduction in their scores over the trial 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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NCT01529632 · results posted 12 February 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01529632) enrolled 193 people in total — 90 in the QVA149 group and 103 in the QAB149 + NVA237 group. The vast majority completed the study (87 and 100 respectively, with only 3 in each group not finishing). The trial was comparing two inhaled breathing treatments over 28 days in people with a chronic lung condition. The main thing being measured was lung function — specifically how much air participants could forcibly breathe out in one second (called FEV1), recorded at a set point near the end of the 28-day treatment period. The reported data shows that after 28 days, the average "trough FEV1" (a lung function reading taken roughly 23–24 hours after the last dose, when the medicine's effect would be at its lowest point) was 1.459 litres in the QVA149 group and 1.465 litres in the QAB149 + NVA237 group — very similar figures for both groups. The reported data also shows several secondary measurements of lung function taken over a 4-hour window on Days 1 and 28, with values ranging roughly between 1.43 and 1.67 litres across both groups and time points, again with the two groups showing broadly similar numbers throughout. The peak lung function readings (the highest single reading in the 5-minute to 4-hour window after the dose) were reported as 1.668 litres (QVA149) and 1.646 litres (QAB149 + NVA237) on Day 1, and 1.643 litres (QVA149) and 1.654 litres (QAB149 + NVA237) on Day 28. The reported data also shows that participants in both groups used a "rescue" inhaler (a short-acting reliever puffer) during the study. Before treatment, participants in the QVA149 group used an average of about 2.24 puffs per day and those in the QAB149 + NVA237 group used about 2.04 puffs per day. Over the 28 days of treatment, the reported average daily use was 1.85 puffs for the QVA149 group and 1.70 puffs for the QAB149 + NVA237 group. No conclusions about why these numbers changed 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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NCT01072149 · results posted 25 December 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 54 participants in total (18 groups of 3 people each). It was designed to compare three different doses of a combination inhaled medicine — referred to as FF/VI at doses of 50/25, 100/25, and 200/25 micrograms — against a dummy (placebo) inhaler in people with a lung condition. The trial used a "crossover" design, meaning each participant tried different treatments one after another, with rest periods in between, over roughly six months. The main thing being measured was how well participants could breathe out forcefully in one second (a standard lung function test called FEV1), tracked over a 24-hour period at the end of each 28-day treatment stint. The reported data shows that for the main measurement — the average FEV1 reading over 24 hours — the placebo group recorded approximately 1.30 litres, while the three active dose groups recorded approximately 1.53, 1.52, and 1.53 litres for the low, medium, and high doses respectively. For one of the secondary measurements, which looked at how much FEV1 changed from the start of each treatment period to the end (a "trough" reading taken around 23–24 hours after the last dose), the placebo group showed a small decline of about 0.02 litres on average, while the three active dose groups showed increases of approximately 0.19, 0.15, and 0.17 litres respectively. The remaining secondary outcome data (change from baseline in 25-hour serial FEV1) appears to have been truncated in the submitted data and full figures were not available to report 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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NCT00845728 · results posted 19 November 2013

According to the results reported on ClinicalTrials.gov, this trial compared two inhaled medicines — indacaterol and tiotropium — in people with severe COPD (a serious lung condition). A total of 1,723 people were assigned to the indacaterol group and 1,721 to the tiotropium group when the trial began. By the end of the 12-week study, 1,337 people in the indacaterol group and 1,379 in the tiotropium group had completed it. The main thing the trial was measuring was how well each medicine kept the airways open 24 hours after a dose, using a breathing test called FEV1 (which measures how much air a person can breathe out forcefully in one second). The reported data shows that after 12 weeks, the average trough FEV1 — that is, the amount of air breathed out in one second measured just before the next dose was due — was 1.134 litres in the indacaterol group and 1.145 litres in the tiotropium group. The trial was designed to assess whether indacaterol performed comparably to tiotropium on this measure, rather than to show one was superior. For a secondary measure, the reported data shows the rate of COPD flare-ups (periods when symptoms got significantly worse and needed extra treatment) was 0.79 episodes per person per year in the indacaterol group and 0.61 episodes per person per year in the tiotropium 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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NCT01391559 · results posted 7 August 2013

According to the results reported on ClinicalTrials.gov, this trial involved 20 participants in total, split into two groups of 10. It used a "crossover" design, meaning each participant tried both medications — one called arformoterol and one called salmeterol — in a different order. All 20 participants completed both stages of the trial, with no dropouts reported. The trial was measuring changes in lung function after inhaling each medication, specifically looking at a breathing test called FEV1 (Forced Expiratory Volume in 1 Second), which measures how much air a person can forcefully breathe out in one second. The reported data shows that two hours after inhaling the study medication, participants' FEV1 results changed from their starting point by an average of 84 millilitres in the arformoterol group and 52 millilitres in the salmeterol group. In plain terms, both groups showed an increase in the amount of air they could breathe out, with the arformoterol group showing a larger reported change in this measurement. No other outcome measures were included in the structured results 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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NCT00430300 · results posted 8 July 2013

According to the results reported on ClinicalTrials.gov, this trial tested three different doses of an inhaled investigational medicine called UK-432,097 (150 micrograms, 450 micrograms, and 1,350 micrograms) compared to a placebo (an inactive treatment) in people with a lung condition. A total of 87 people started the trial — 17 in the lowest-dose group, 18 in the middle-dose group, 35 in the highest-dose group, and 17 in the placebo group. The main thing the trial was measuring was a breathing test called FEV1 — this is simply how much air a person can forcefully breathe out in one second — and whether it changed after six weeks of treatment. The reported data shows that at the start of the trial, FEV1 readings across all four groups ranged from about 1.33 to 1.48 litres. After six weeks, the change from those starting figures was very small across all groups: the 150 mcg group changed by –0.01 litres, the 450 mcg group by –0.05 litres, the 1,350 mcg group by –0.05 litres, and the placebo group also by –0.05 litres. The reported data shows similarly small changes across the additional breathing measurements taken at weeks 2, 4, and 8 — including measures of air exhaled over six seconds, total breath capacity, and the volume of air that can be drawn in after a normal breath out — with figures generally shifting by less than 0.15 litres in any direction across all groups. The reported data shows that the numbers across the active treatment groups and the placebo group were broadly similar for all the breathing measurements recorded throughout the trial. Where participants did not complete the study, the data was not reported broken down by reason. 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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NCT00399308 · results posted 16 May 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people in total across three groups: 13 received a weekly application of a treatment called Celaderm, 15 received Celaderm every two weeks, and 12 were in a control group (meaning they did not receive Celaderm). The trial was measuring whether Celaderm helped wounds close completely, looking at things like full wound closure and how much the wound surface had regrown (a process called re-epithelialisation — where the skin surface rebuilds itself over a wound). Nearly all participants finished the trial; only one person in the control group did not complete it. The reported data shows that after 12 weeks of active treatment, 1 out of 13 participants in the weekly Celaderm group, 4 out of 15 in the twice-weekly group, and 3 out of 11 in the control group had their wounds judged as completely closed by the investigator. For the secondary measure of at least 90% skin regrowth over the wound after 12 weeks, the reported numbers were 1 out of 13 in the weekly group, 5 out of 15 in the twice-weekly group, and 3 out of 11 in the control group. The trial also tracked whether wounds that had closed stayed closed during a follow-up period — the reported data shows that 0 participants in the weekly group, 1 in the twice-weekly group, and 0 in the control group had their wound reopen during follow-up. Finally, looking at wound closure by the end of the full 24-week study period (including the follow-up phase), the reported numbers were 3 out of 13 in the weekly group, 7 out of 15 in the twice-weekly group, and 5 out of 11 in the control group. It is worth noting that this was a relatively small trial with fewer than 15 people in each group, which limits how much can be concluded from these numbers alone. The reported data shows how many participants in each group reached the measured outcomes, but no further interpretation of what those differences mean 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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NCT01202188 · results posted 3 May 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 2,144 people across five treatment groups. Participants received one of the following: a combination of two inhaled medicines called indacaterol and glycopyrronium (together called QVA149), indacaterol alone, glycopyrronium alone, tiotropium (another inhaled medicine), or a placebo (inactive treatment). The trial ran for 26 weeks and was primarily measuring lung function — specifically, how much air participants could breathe out forcefully in one second (known as FEV1), measured at a set time after taking their dose. It also looked at breathlessness, quality of life related to breathing, and use of "rescue" inhalers (quick-relief puffs taken as needed). The reported data shows that after 26 weeks, the average trough FEV1 (the air breathed out measurement taken roughly 23–24 hours after the last dose, when the medicine's effect is at its lowest) was 1.45 litres in the combination group, 1.38 litres in the indacaterol-alone group, 1.36 litres in the glycopyrronium-alone group, 1.39 litres in the tiotropium group, and 1.25 litres in the placebo group. For breathlessness, scores on a standard scale (ranging from –9 meaning major worsening to +9 meaning major improvement) were reported as 2.72 for the combination group and 1.63 for the placebo group. On a quality-of-life breathing questionnaire (where lower scores mean better health, out of 100), the combination group scored 37.01 and the placebo group scored 40.02. For rescue inhaler use, the combination group showed an average reduction of 1.88 puffs per day from their starting level, compared to a reduction of 0.92 puffs per day in the placebo group. These figures are what was recorded and submitted to the clinical trials registry, but they represent group averages from a specific study population and may not reflect what any individual person would experience. 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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NCT01294787 · results posted 20 March 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 85 people across six groups, with each person rotating through three different treatments over the course of the study: a combination inhaled medicine called QVA149 (containing two active ingredients, indacaterol and glycopyrronium bromide), a single inhaled medicine called tiotropium, and a placebo (an inactive treatment). By the end of all three periods, around 73 participants had completed the full trial. The main thing the trial was measuring was how long participants could keep pedalling on a stationary exercise bike — known as exercise endurance time — after three weeks on each treatment. The reported data shows that, for the primary measure, participants in the QVA149 group recorded an average exercise endurance time of about 508 seconds (roughly 8.5 minutes), compared to about 448 seconds (roughly 7.5 minutes) in the placebo group. For the secondary measures, the trial also looked at lung capacity readings taken at rest and during exercise. One measure called "inspiratory capacity" — essentially how much air a person can breathe in — was recorded during the exercise test: the QVA149 group averaged 2.42 litres, the tiotropium group 2.29 litres, and the placebo group 2.11 litres. A similar pattern was seen in resting lung capacity readings (measured 24 hours after a dose), where QVA149 recorded 2.25 litres, tiotropium 2.10 litres, and placebo 2.06 litres. Breathing-out capacity (called FEV1 — the amount of air someone can forcibly breathe out in one second) was 1.53 litres for QVA149, 1.43 litres for tiotropium, and 1.33 litres for placebo. Additional lung volume measurements taken on days 1 and 21 of each treatment period followed broadly similar patterns across the 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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NCT00358436 · results posted 1 November 2012

According to the results reported on ClinicalTrials.gov, this trial looked at a medication called aclidinium bromide (at a dose of 200 micrograms, taken once daily) compared to a placebo (a dummy treatment with no active ingredient) in people with COPD, a long-term lung condition. A total of 804 people started the trial — 600 in the aclidinium group and 204 in the placebo group. The trial measured lung function using a test called FEV1, which records how much air a person can forcefully breathe out in one second. It also looked at how long it took before people had a serious flare-up of their COPD symptoms, and whether people's quality of life improved over the course of the study. The reported data shows that at 12 weeks, the average FEV1 reading was 1.233 litres in the aclidinium group and 1.171 litres in the placebo group. At 28 weeks, those figures were 1.220 litres and 1.162 litres respectively. For the quality-of-life measure — based on a questionnaire called the St George's Respiratory Questionnaire, where a drop of at least 4 points is considered a meaningful improvement — the reported data shows that 39% of people in the aclidinium group and 32.8% of people in the placebo group reached that threshold at 52 weeks. Regarding the time to a first serious flare-up of COPD symptoms, the data for this outcome was not reported in the results submitted to ClinicalTrials.gov. It is also worth noting that not everyone completed the trial — 446 of the 600 people in the aclidinium group finished, as did 118 of the 204 in the placebo group, meaning a notable number of participants in both groups did not complete the study. The reasons for this were not detailed 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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NCT00846287 · results posted 1 November 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people in total — 16 in a saline (placebo) group and 15 in a drug group (receiving a medication called Brovana). Not everyone finished the trial: 6 people in the saline group and 10 in the drug group completed it, while 10 and 5 people respectively did not complete it. The trial was measuring two things: how much of the lungs appeared ventilated (filled with air) using a special type of MRI scan involving inhaled helium-3 gas, and how much air a person could forcefully breathe out in one second (known as FEV1, a standard lung function test). Both measurements were taken before and about two hours after participants inhaled their assigned treatment through a nebuliser (a device that turns liquid medicine into a mist). The reported data shows the following changes in total ventilated lung volume (measured in litres): the saline group showed an average increase of approximately 0.15 litres, while the Brovana group showed an average decrease of approximately 0.14 litres. For the secondary measure — the change in the amount of air forcefully breathed out in one second — the reported data shows the saline group had an average decrease of 0.12 litres, while the Brovana group had an average increase of 0.16 litres. These are the numbers as submitted; the trial report does not include additional context such as whether these differences between groups were considered statistically meaningful (i.e., unlikely to be due to chance). 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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NCT01001494 · results posted 17 September 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 819 people across three groups: 277 received a lower dose of aclidinium bromide (200 micrograms, twice daily), 269 received a higher dose (400 micrograms, twice daily), and 273 received a placebo (an inactive treatment). 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. This was checked at 12 weeks and again at 24 weeks. The trial also looked at breathlessness and quality of life using two questionnaires. The reported data shows that, for the main lung function measure at 24 weeks, the lower-dose group's FEV1 score increased by an average of 0.026 litres from their starting point, the higher-dose group's increased by 0.055 litres, and the placebo group's decreased by 0.073 litres. Similar patterns were reported at 12 weeks. For the peak (best single) breathing measurement at 24 weeks, the reported increases were 0.206 litres for the lower-dose group, 0.231 litres for the higher-dose group, and 0.022 litres for the placebo group. On the breathlessness questionnaire at 24 weeks, 53.3% of the lower-dose group and 56.9% of the higher-dose group showed a meaningful improvement, compared with 45.5% in the placebo group. For the quality-of-life questionnaire, 56.0% of the lower-dose group and 57.3% of the higher-dose group showed a meaningful improvement, compared with 41.0% 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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NCT01044459 · results posted 13 September 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 605 people in total — 312 in the group receiving a 200 microgram dose of aclidinium bromide, and 293 in the group receiving a 400 microgram dose. Aclidinium bromide is an inhaled medicine being studied for a breathing condition, and the trial ran for 52 weeks. Not all participants finished the trial — 179 people completed it in the lower-dose group and 162 in the higher-dose group, with 133 and 131 people respectively not completing it. The trial was primarily measuring changes in a breathing test called FEV1, which stands for the amount of air a person can forcefully breathe out in one second — a common way of assessing lung airflow. The reported data shows that, after 52 weeks, the main measurement — taken in the morning before participants took their dose (called a "trough" reading, meaning the lowest point of the medicine's effect) — changed from the starting point by an average of 0.034 litres in the 200 microgram group and 0.072 litres in the 400 microgram group. A secondary measurement looked at the highest FEV1 reading achieved after taking the dose (called "peak FEV1"). The reported data shows this changed from the starting point by an average of 0.185 litres in the 200 microgram group and 0.214 litres in the 400 microgram group at week 52. No other outcome data was included in the submitted results. These figures describe what was measured and recorded — they do not on their own tell us whether the changes are meaningful for everyday breathing or quality of life. 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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NCT00542880 · results posted 30 August 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 442 adults across two groups — 217 started by using Symbicort Turbuhaler first and then switched to Seretide Diskus, while 225 started with Seretide Diskus first and then switched to Symbicort Turbuhaler. It was a crossover study, meaning every participant used both inhalers at different points during the trial. The trial was measuring lung function, specifically how well air could be blown out of the lungs, using two common tests: Peak Expiratory Flow (PEF — the fastest speed at which a person can breathe out) and FEV1 (the amount of air a person can forcefully breathe out in one second). Around 404–407 participants completed the full trial. The reported data shows that the main result being tracked was the change in PEF measured five minutes after the morning dose, compared to where each participant started (their baseline). Participants using Symbicort Turbuhaler showed an average increase of 15.1 litres per minute from their baseline, while those using Seretide Diskus showed an average increase of 13.4 litres per minute. For the secondary measurements, the reported data shows that PEF measured 15 minutes after the morning dose increased by 19.9 litres per minute with Symbicort and 16.7 with Seretide. PEF before the morning dose increased by 4.8 litres per minute with Symbicort and 7.9 with Seretide, and before the evening dose, increases were 4.0 and 1.8 litres per minute respectively. For FEV1 before the morning dose, the reported increases were 0.031 litres for Symbicort and 0.059 litres for Seretide; measured 15 minutes after the morning dose, the increases were 0.122 litres for Symbicort and 0.103 litres for Seretide. 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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NCT00949975 · results posted 3 August 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 838 people across four groups to test three different doses of an investigational medicine called AZD9668 (5 mg, 20 mg, and 60 mg) compared to a placebo (a dummy treatment with no active ingredient). The trial ran for 12 weeks and was primarily measuring lung function using a breathing test called FEV1 — this measures how much air a person can forcefully breathe out in one second, expressed in litres. A second breathing measure called FVC (the total amount of air someone can breathe out in one go) was also recorded. Between 177 and 190 participants in each group completed the trial. The reported data shows that at the start of the trial, all four groups had very similar FEV1 readings before using a breathing-relief inhaler (around 1.47–1.51 litres across all groups). At the end of the 12-week treatment period, the reported FEV1 readings remained similarly close across all groups — ranging from approximately 1.46 to 1.51 litres. The reported data also shows that FEV1 readings taken after inhaler use, and FVC readings, were likewise very similar between the AZD9668 groups and the placebo group at both the start and end of the study, with all values falling within a narrow range of each other. 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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NCT01494610 · results posted 23 May 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 60 adults in total — 31 in one group and 29 in another — all of whom had either asthma or chronic obstructive pulmonary disease (COPD, a long-term lung condition). The trial used a "crossover" design, meaning each participant took both of the treatments being compared at different times: a combination inhaler medicine (fluticasone propionate/salmeterol, or FP/salmeterol) delivered through a new dry-powder device called an MDPI, and the same medicine delivered through an older capsule-based inhaler. The trial was primarily measuring how much of the medicine got into the bloodstream, and also looking at a hormone called cortisol (which can be affected by inhaled steroid medicines) as a way of gauging the body's exposure to the steroid component. The reported data shows that for the primary measure of how much FP (the steroid part of the medicine) was absorbed into the blood over a 12-hour dosing period, the MDPI device produced lower readings than the capsule-based inhaler across all participant groups — for example, roughly 377 versus 573 (in the unit used to measure this, picogram hours per millilitre) in one group, and similar patterns in the others. For the cortisol measure, the reported data shows that cortisol levels were somewhat higher with the MDPI device than with the capsule-based inhaler — for instance, around 194 versus 178 nanomoles per litre in one group. The secondary measures, which tracked how the salmeterol (the other medicine component) and FP behaved in the blood over time, also generally showed lower blood levels with the MDPI device compared to the capsule-based inhaler across the reported figures. 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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NCT01005901 · results posted 12 April 2012

According to the results reported on ClinicalTrials.gov, this trial compared a medication called glycopyrronium bromide against a placebo (a dummy treatment with no active ingredient) in people with chronic obstructive pulmonary disease (COPD). A total of 552 people were assigned to the glycopyrronium bromide group and 270 to the placebo group when the study began, with 450 and 212 people respectively completing the trial. The main thing the trial was measuring was a lung function test called FEV1 — this measures how much air a person can forcefully breathe out in one second — taken at 12 weeks. The trial also tracked several secondary measures over 26 weeks, including breathlessness, quality of life, use of "rescue" (relief) medication, and the time until a serious worsening of COPD symptoms. The reported data shows that at 12 weeks, the average trough FEV1 (a reading taken roughly 23–24 hours after the last dose, representing the lowest point of the medication's effect) was 1.408 litres in the glycopyrronium bromide group compared with 1.301 litres in the placebo group. For the breathlessness score at 26 weeks (measured on a scale where a score of +1 or more is considered a meaningful improvement), the glycopyrronium bromide group recorded 1.84 and the placebo group recorded 0.80. Quality of life was assessed using a questionnaire scored from 0 to 100, where lower numbers mean better quality of life; the reported scores at 26 weeks were 39.50 for glycopyrronium bromide and 42.31 for placebo. Regarding rescue medication use, participants in the glycopyrronium bromide group used an average of 1.21 fewer puffs per day compared to their starting point, while the placebo group used an average of 0.75 fewer puffs per day. For the time to a first serious worsening of symptoms, no specific number of days 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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NCT01110252 · results posted 26 March 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 4 participants, all of whom completed both stages of the study. It was a before-and-after design, meaning the same 4 people had measurements taken prior to a stem cell infusion procedure and then again afterwards. The trial was measuring how well the participants' lungs were working, using breathing tests and blood tests. The reported data shows the following numbers for the breathing tests. A measure called Forced Vital Capacity (FVC) — roughly, the total amount of air a person can breathe in — went from 1.5 litres before the procedure to 2.1 litres afterwards. A measure called Forced Expiratory Volume (FEV1) — the amount of air a person can breathe out in one second — went from 0.7 litres to 0.8 litres. A third breathing measure, Vital Capacity (VC) — a combined measure of air breathed in and out — went from 1.8 litres before the procedure to 1.4 litres afterwards. The reported data also shows results from blood tests measuring gases in the arteries. The level of oxygen measured in the blood (PaO2) went from 69 mmHg before the procedure to 57 mmHg afterwards. The level of carbon dioxide in the blood (PaCO2) went from 48.75 mmHg before the procedure to 89.25 mmHg afterwards. It is worth noting that with only 4 participants, these figures represent a very small group, and no information about statistical analysis (that is, how reliably these numbers reflect a true pattern) 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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NCT00876694 · results posted 8 November 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 186 people in total — 125 received a inhaled medicine called indacaterol (300 micrograms) and 61 received another inhaled medicine called salmeterol (50 micrograms). Of those, 104 and 49 participants respectively completed the 52-week study. The trial was set up to track certain body measurements — heart rate, blood pressure, a heart electrical reading called the QTc interval (a measure of the heart's electrical activity timing), and blood levels of potassium and glucose — to see how often any of those readings reached levels considered clinically notable (that is, unusually high or low by pre-set definitions). The reported data shows that very few participants reached the pre-defined notable thresholds for heart rate or blood pressure. For heart rate, 1 participant in the indacaterol group recorded a notably low reading, and none in either group recorded a notably high reading. For blood pressure, 1 participant in the indacaterol group had a notably high systolic (top number) reading, and 1 participant in the salmeterol group had a notably low diastolic (bottom number) reading. For the QTc heart electrical interval, the reported data shows 6 indacaterol and 3 salmeterol participants exceeded the notable threshold value; 12 indacaterol and 3 salmeterol participants had an increase from their starting value in the 30–60 millisecond range; and no indacaterol participants versus 1 salmeterol participant had an increase greater than 60 milliseconds. The reported data also shows that average blood potassium levels across measurement points ranged from roughly 4.26 to 4.35 mmol/L in the indacaterol group and 4.27 to 4.35 mmol/L in the salmeterol group. Average blood glucose levels (measured one hour after dosing) ranged from approximately 5.92 to 6.16 mmol/L in the indacaterol group and 5.96 to 6.59 mmol/L in the salmeterol group across the various 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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NCT00615030 · results posted 17 August 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 95 participants across 12 groups, each following a different sequence of treatments over three periods. The trial was comparing different inhaled breathing medications — indacaterol (taken in the morning or evening), salmeterol (another inhaled medication), and a placebo (an inactive dummy treatment) — in people with a lung condition. The main thing being measured was lung function, specifically a test called FEV1 (Forced Expiratory Volume in 1 second), which measures how much air a person can breathe out forcefully in one second. A higher FEV1 reading generally indicates more airflow. Participants were tested after 14 days on each treatment. The reported data shows that for the primary measure — comparing indacaterol taken in the evening against placebo after 14 days — the average FEV1 reading was 1.57 litres for those on indacaterol evening dosing, compared with 1.37 litres for those on placebo. The reported data also shows results for other comparisons: indacaterol taken in the morning recorded an average FEV1 of 1.56 litres, salmeterol taken in the morning recorded 1.51 litres, and salmeterol taken in the evening recorded 1.46 litres. The placebo groups recorded 1.36 litres (morning) and 1.37 litres (evening). These are the numbers as submitted; no further detail about what drove these differences was reported in the structured 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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NCT00792805 · results posted 17 August 2011

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called indacaterol (tested at two different doses — 150 micrograms and 300 micrograms) compared to a placebo (a dummy treatment with no active ingredient) in people with a lung condition. A total of 563 people were enrolled across the three groups — roughly 188 in each — and the trial ran for 12 weeks. The main thing being measured was lung function, specifically how much air participants could forcefully breathe out in one second (known as FEV1). This measurement was taken about 23–24 hours after the last dose, to see how well the medicine's effect lasted overnight. The reported data shows that at the end of the 12-week treatment period, the average FEV1 reading was 1.32 litres in the 150 microgram indacaterol group, 1.29 litres in the 300 microgram indacaterol group, and 1.17 litres in the placebo group. These numbers represent averages across participants in each group at that single time point. It is worth noting that the trial did not report completing data for all participants who started — 166, 162, and 154 people finished in each group respectively, meaning some participants left the trial early. No secondary outcome measure data was included in the structured results 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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NCT00615459 · results posted 17 August 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 167 participants across four groups, who each rotated through three different treatment periods in a different order — a design sometimes called a "crossover" trial. The treatments being compared were two doses of indacaterol (150 micrograms and 300 micrograms), tiotropium (18 micrograms), and a placebo (dummy treatment with no active ingredient). The main thing the trial was measuring was lung function — specifically, how much air participants could forcefully breathe out in one second (called FEV1), tested roughly 24 hours after their last dose, following 14 days on each treatment. The reported data shows that after 14 days, the average FEV1 readings at the 24-hour mark were 1.53 litres for the indacaterol 150 μg group, 1.51 litres for the indacaterol 300 μg group, 1.48 litres for the tiotropium group, and 1.36 litres for the placebo group. The trial also measured peak lung function in the first four hours after the very first dose on Day 1. The reported data shows those peak FEV1 readings were 1.65 litres for indacaterol 150 μg, 1.67 litres for indacaterol 300 μg, 1.62 litres for tiotropium, and 1.48 litres for placebo. Not all participants who started the trial completed every period, though most did. 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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NCT00297102 · results posted 19 May 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 765 people in the roflumilast group and 758 people in the placebo group — a total of 1,523 participants — all of whom had a lung condition called COPD (chronic obstructive pulmonary disease). The trial was measuring two main things: changes in a breathing test called FEV1 (which measures how much air a person can forcefully breathe out in one second), and the rate at which participants experienced moderate or severe COPD flare-ups (called exacerbations) over the course of the study. Of those who started, 502 in the roflumilast group and 525 in the placebo group completed the trial. The reported data shows that, on average, participants taking roflumilast had a change of +46 millilitres in their pre-bronchodilator FEV1 breathing test from the start of the study, compared with +8 millilitres in the placebo group. For the post-bronchodilator FEV1 (measured after using a reliever inhaler), the reported figures were +57 millilitres for roflumilast and +8 millilitres for placebo. Regarding flare-ups, the reported rate was approximately 1.08 flare-ups per person per year in the roflumilast group, compared with approximately 1.27 in the placebo group. The reported data also shows results for several secondary measurements. The average time recorded until death from any cause was reported as approximately 214 days for the roflumilast group and approximately 208 days for the placebo group — though it is important to note this figure reflects a time-point within the study period, not overall survival. A blood marker of inflammation called C-reactive protein showed a reported change of 1.05 in the roflumilast group and 1.10 in the placebo group (measured on a mathematical scale). Breathlessness, measured using a questionnaire called the Transition Dyspnea Index (scored from −9 to +9, where higher scores suggest greater improvement), was reported as 0.66 for roflumilast and 0.43 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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NCT00862641 · results posted 15 December 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled people with either asthma or chronic obstructive pulmonary disease (COPD) to look at whether a drug called regadenoson affected their breathing compared to a dummy treatment (placebo). In total, 177 people with asthma received placebo and 360 received regadenoson, while 152 people with COPD received placebo and 320 received regadenoson — just over 1,000 participants in all. The vast majority in each group completed the study. The main thing the trial measured was how many participants experienced a notable drop (greater than 15%) in a breathing test result called FEV1 — which is simply a measure of how much air someone can forcefully breathe out in one second — at two hours after receiving the study drug. The reported data shows that in the asthma groups, 2.9% of those on placebo and 1.1% of those on regadenoson had this level of drop. In the COPD groups, 5.4% of those on placebo and 4.2% of those on regadenoson had this level of drop. The reported data also shows that the average change in the breathing test scores from before to two hours after the dose was small across all four groups, and the numbers of participants who needed to use a short-acting reliever inhaler for breathing-related symptoms during the study were low — ranging from 1 to 5 people per group depending on the measure 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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NCT00638183 · results posted 5 April 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 385 people, all of whom received a treatment called Spiriva (tiotropium), an inhaled medication for lung conditions. The trial was conducted over one year and tracked two main things: how many participants experienced unwanted health events (called adverse events and adverse drug reactions), and as secondary measures, how participants' lung function and overall condition changed over time. Of the 385 people who started, 266 completed the trial, and 119 did not finish. The reported data shows that, when it came to the primary measures, 71 out of 385 participants experienced some kind of adverse event (an unwanted health occurrence during the trial), and 27 out of 385 experienced an adverse drug reaction — meaning an unwanted event that investigators considered to be related to the medication. For the secondary measures, the reported data shows that participants' lung function, measured by how much air they could breathe out forcefully in one second (FEV1), increased on average by 0.119 litres over 52 weeks compared to where they started. Additionally, when investigators gave an overall assessment of each participant's condition at the end of the study — considering both lung function and symptoms — the reported data shows that 70.9% of assessed participants were rated as having "improved." It is worth noting that this trial had only one group, meaning everyone received the same treatment and there was no comparison group, so the numbers above reflect that single group only. 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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NCT00387088 · results posted 22 January 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,989 people in the tiotropium (the active treatment) group and 2,002 people in the placebo (dummy treatment) group — nearly 4,000 participants in total. The trial was measuring two main things: how much a breathing test score called FEV1 (which reflects how much air a person can forcefully breathe out in one second) changed over roughly 11 months, and how long it took before participants had a flare-up of their COPD (a period of worsening symptoms lasting at least three days that needed a change in treatment). The reported data shows that, on average, the FEV1 score in the tiotropium group increased by 0.119 litres from where it started at the end of the study period (around Day 337), compared with an increase of 0.018 litres in the placebo group. Similar patterns were reported at earlier time points — at around one month (Day 29), the figures were 0.110 litres versus 0.017 litres, and at around five and a half months (Day 169), 0.121 litres versus 0.018 litres. For the time-to-first-flare-up outcome, the reported data shows the values were listed as "not available," meaning those particular summary figures were not reported in the structured results submitted. For the exacerbation count outcomes, the reported values were listed as zero for both groups, though this likely reflects how the data was entered rather than meaning no flare-ups occurred at all — the data as submitted does not provide further detail on this 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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NCT00613574 · results posted 18 January 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 407 people, all of whom received the inhaled medication Spiriva® (tiotropium bromide). Of those, 401 completed the study, while 6 did not finish. The trial was measuring changes in lung function over 8 weeks, specifically looking at how much air participants could breathe out and breathe in, as well as asking both patients and their doctors to rate their overall experience with the medication on a simple four-point scale (where 1 = excellent and 4 = poor). The reported data shows that, on average, participants' post-dose forced expiratory volume in one second (the amount of air a person can forcefully breathe out in one second) increased by 0.29 litres from the start of the study to week 8. Two other breathing measurements also showed reported increases: the total amount of air participants could breathe out in one breath went up by 0.31 litres on average, and the amount of air participants could breathe in (measured only at selected study sites) went up by 0.18 litres on average. The reported data also shows how participants and doctors rated the medication at the end of the 8 weeks. Out of 401 participants who gave a patient rating of the medication's effect: 141 rated it "excellent," 198 rated it as the second category, 60 rated it third, and 2 rated it "poor." For tolerability (how well they felt they handled the medication), 246 participants rated it "excellent," 139 rated it second, 16 rated it third, and none rated it "poor." Doctors' ratings followed a similar pattern, with 159 rating it "excellent," 195 rating it second, 45 rating it third, and 2 rating it "poor." 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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NCT00680056 · results posted 3 December 2009

According to the results reported on ClinicalTrials.gov, this trial involved 33 people in total (16 in one group and 17 in the other). It used a "crossover" design, meaning participants tried both treatments in sequence — one group started on formoterol plus a dummy version of tiotropium, and the other started on formoterol plus tiotropium, with a one-week break in between before swapping. The trial was measuring whether adding tiotropium to formoterol made a difference to how long people could exercise on a treadmill, and how they rated their breathlessness. The reported data shows that, after two weeks, the group taking formoterol plus the dummy tiotropium had an average 68% increase in how long they could keep up with a high-intensity treadmill test compared to their starting point. The group taking formoterol plus tiotropium had an average 124% increase compared to their starting point. For breathlessness, the trial used a rating scale called the Transitional Dyspnea Index, which runs from −9 (meaning breathing felt much worse) to +9 (meaning breathing felt much better). The reported data shows the formoterol plus dummy tiotropium group scored an average of 2.9 on this scale, while the formoterol plus tiotropium group scored an average of 3.8 — both above zero, meaning both groups reported some improvement from where they started. It is worth noting that this was a small trial, and some participants did not complete both phases — the data was not reported in a way that explains why. 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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NCT00168831 · results posted 7 October 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,007 people with COPD (a chronic lung condition) across three groups: 338 received a lower dose of tiotropium Respimat (5 mcg), 335 received a higher dose (10 mcg), and 334 received a placebo (an inactive treatment). The trial ran for 48 weeks and measured several things, including lung function, quality of life, breathlessness, and how often participants had flare-ups of their lung condition. Not everyone finished the trial — 278, 254, and 220 people completed it in the three groups respectively. It is worth noting that two of the four primary outcome measures combined data from this trial and a separate twin study (NCT00168844). The reported data shows that for the main lung function measure — how much air a person can breathe out in one second (called FEV1) — the average change from the start of the trial after 48 weeks was an increase of 0.077 litres in the low-dose group and 0.105 litres in the high-dose group, compared to a decrease of 0.036 litres in the placebo group. For quality of life (scored 0–100, where lower is better), the reported scores at the end were 39.8 and 40.0 in the two tiotropium groups, compared to 43.5 in the placebo group. For breathlessness (scored −9 to +9, where higher means more improvement), the reported scores were 1.89 and 1.91 in the tiotropium groups compared to 0.84 in the placebo group. The reported rate of COPD flare-ups per person per year was 0.93 and 1.02 in the tiotropium groups, compared to 1.91 in the placebo group. For the secondary measures, small changes in heart rate and a heart-timing measurement (PR interval) were also recorded across all three groups, with the reported figures differing only modestly between 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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NCT00168844 · results posted 7 October 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 983 people with COPD (a chronic lung condition) across three groups: 332 received a lower dose of tiotropium via the Respimat inhaler (5 micrograms), 332 received a higher dose (10 micrograms), and 319 received a placebo (an inactive treatment). The trial ran for 48 weeks and was measuring four main things: lung function (using a breathing test called FEV1, which measures how much air a person can forcefully breathe out in one second), quality of life (using a respiratory questionnaire scored from 0 to 100, where lower is better), breathlessness (scored from −9 to +9, where higher is better), and how often participants had flare-ups of their COPD. Two of these measurements — breathlessness and flare-up rate — were reported by combining the results from this trial with those from a closely related twin study. The reported data shows that, at 48 weeks, the average change in the breathing test (FEV1) from the start of the trial was an increase of 0.097 litres in the lower-dose group and 0.116 litres in the higher-dose group, while the placebo group showed a small decrease of 0.046 litres. For the quality-of-life questionnaire, average scores were 39.6 (lower dose), 38.7 (higher dose), and 42.9 (placebo) — remembering that lower scores represent better quality of life on this scale. For breathlessness (combining both twin studies), average scores were 1.89 (lower dose), 1.91 (higher dose), and 0.84 (placebo) on the −9 to +9 scale. The reported COPD flare-up rate (also combining both studies) was 0.93 flare-ups per person per year in the lower-dose group, 1.02 in the higher-dose group, and 1.91 in the placebo group. The reported data also shows two secondary measurements related to heart function. Average heart rate change from the start of the study was +2.1 beats per minute (lower dose), +3.6 beats per minute (higher dose), and +1.8 beats per minute (placebo). A measurement of electrical activity in the heart called the PR interval (a figure measured in milliseconds) changed by −0.8 ms (lower dose), −2.5 ms (higher dose), and −0.5 ms (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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NCT00254566 · results posted 2 September 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 198 people in each of two groups — one group received an antibiotic called azithromycin, and the other received an antibiotic called moxifloxacin — for a total of 396 participants. The trial was looking at people with a flare-up of a lung condition called chronic obstructive pulmonary disease (COPD), and it measured whether their symptoms returned to normal or improved enough that no further antibiotics were needed (called "clinical cure"). By the end of the study, 167 people in the azithromycin group and 172 in the moxifloxacin group had completed the trial. The reported data shows that, among the most strictly defined group of participants (called the "per protocol" group), 93.0% of those taking azithromycin and 94.2% of those taking moxifloxacin were recorded as achieving clinical cure at their follow-up check-up. When a broader group of participants was included in the analysis, those cure figures were 88.4% for azithromycin and 90.9% for moxifloxacin. The trial also looked at whether bacteria causing the infection had cleared — 96.0% of bacterial cases in the azithromycin group and 96.7% in the moxifloxacin group showed clearance, according to the reported results. In terms of how long it took before 25% of cured participants had another flare-up, the reported data shows this occurred at around 152 days for the azithromycin group and 204 days for the moxifloxacin group. Finally, both groups showed a small reported reduction in a symptom questionnaire score (azithromycin: −0.76 points; moxifloxacin: −0.71 points on a 0–6 scale), where a lower score indicates fewer symptoms. 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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NCT00144339 · results posted 17 August 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 3,006 people in the placebo group and 2,986 people in the tiotropium bromide (an inhaled medication) group — nearly 6,000 participants in total. The trial ran for approximately four years and was measuring whether tiotropium bromide affected the rate at which lung function declined over time in people with chronic obstructive pulmonary disease (COPD). The main lung function measurement used was FEV1 — the amount of air a person can forcefully breathe out in one second — which is a common way of tracking lung health over time. Not everyone completed the study: around 1,648 people in the placebo group and 1,887 in the tiotropium group finished the full trial period. The reported data shows that, for the primary outcomes, both groups experienced a decline in lung function over the four years. Before using a bronchodilator (a medication that opens the airways before testing), both the placebo group and the tiotropium group showed a decline of 30 millilitres per year in FEV1. After using a bronchodilator before testing, the placebo group declined by 42 millilitres per year and the tiotropium group by 40 millilitres per year. For the secondary outcomes, looking at the full study period including 30 days after treatment ended, the pre-bronchodilator decline was 17 ml/year for placebo and 15 ml/year for tiotropium; the post-bronchodilator decline was 32 ml/year for placebo and 27 ml/year for tiotropium. The reported data also shows that the rate of decline in a related lung measurement called FVC (the total amount of air someone can breathe out forcefully) was broadly similar between both groups, ranging from approximately 39 to 61 millilitres per year depending on the measurement method used. 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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NCT00677690 · results posted 20 April 2009

According to the results reported on ClinicalTrials.gov, this trial involved 83 people in total — 42 in a group that received neuromuscular stimulation (a technique that uses mild electrical impulses to activate muscles) combined with pulmonary rehabilitation (a structured exercise and education programme for lung conditions), and 41 in a group that received pulmonary rehabilitation alone. All 83 participants completed the study. The trial was measuring how far participants could walk in six minutes, how strong their thigh muscles were, how breathless they felt, their breathing function, and their quality of life. The reported data shows the following end-of-study figures. For the six-minute walk test (the main measure of exercise capacity), the combined treatment group walked an average of 465.5 metres, compared with 462.7 metres in the pulmonary rehabilitation-only group. For thigh muscle strength — measured by how many times a person could stand up and sit down in one minute — the averages were 13.5 repetitions and 13.6 repetitions respectively. Breathing function, measured as a percentage of what would be expected for a healthy person of the same age and size, was reported as 50.1% for the combined group and 49.6% for the other group. Breathlessness was rated on a five-point scale (0 = no breathlessness, 4 = most severe), with averages of 2.4 and 2.6. Quality of life was measured on a scale of 0 to 100 (where higher scores mean greater impairment), with averages of 41.7 and 42.05 for 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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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.