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Reported trial results for Interstitial Lung Disease

Every Interstitial Lung Disease 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.

71 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

NCT05964335 · results posted 26 June 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05964335) enrolled 165 adults who were divided into four groups: one group received a placebo (a dummy treatment with no active ingredient), and three groups received different doses of an extended-release form of nalbuphine (NAL ER) — 27 mg, 54 mg, or 108 mg. The trial ran for six weeks and was primarily measuring changes in how often participants coughed over a 24-hour period, tracked using a digital cough monitor. The study appeared to be focused on coughing in people with a lung condition called idiopathic pulmonary fibrosis (IPF), a condition where the lungs gradually stiffen over time. The reported data shows that the main (primary) outcome — the percentage change in coughs per hour over 24 hours from the start to week six — was a reduction of about 0.19% in the placebo group, 0.90% in the 27 mg group, 1.27% in the 54 mg group, and 1.32% in the 108 mg group. For awake coughing specifically, the placebo group actually showed an increase of about 63%, while the three NAL ER groups showed reductions of around 45%, 51%, and 57% respectively. When looking at how many participants had at least a 75% drop in their 24-hour cough count, the reported data shows this was 5.4% of the placebo group, 17.5% in the 27 mg group, 37.1% in the 54 mg group, and 43.2% in the 108 mg group. A symptom questionnaire score related to coughing also showed reported reductions across all groups. The reported data also shows that the number of participants who experienced at least one adverse event (an unwanted medical occurrence during the trial) was 25 out of 40 in the placebo group, 30 out of 42 in the 27 mg group, 34 out of 43 in the 54 mg group, and 33 out of 40 in the 108 mg group — though the data does not detail the nature of those events 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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NCT03155620 · results posted 14 April 2026

According to the results reported on ClinicalTrials.gov, this trial — known as the NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol — enrolled 1,377 children and young people with advanced solid tumours, non-Hodgkin lymphomas, or histiocytic disorders (a group of rare diseases involving certain immune cells). The trial was a screening study, meaning its main purpose was to test participants' tumours for specific genetic changes that might match them to one of several targeted treatment sub-studies, rather than to directly test a single drug. The reported data shows that the primary thing being measured was the proportion of eligible participants whose tumours contained a genetic change that could potentially be targeted by one of the drugs being studied in the linked sub-studies. According to the results reported on ClinicalTrials.gov, that figure was 28% — meaning that out of the eligible participants screened, 28 in every 100 were found to have a genetic change that matched them to at least one of those sub-studies. It is worth noting that participants enrolled after a certain protocol update (Amendment 4) were not included in this calculation, as the screening approach changed at that point. The reported data shows that the secondary outcome — looking at how tumours without these targetable genetic changes responded to targeted treatment — had no numbers submitted to ClinicalTrials.gov. Similarly, several additional planned analyses, such as mapping the broader genetic landscape of these childhood cancers and examining inherited genetic mutations, were listed but had no numerical results reported in the submitted data. These results as reported represent only what was measured during screening and cannot be used to draw conclusions about individual cases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04195555 · results posted 25 March 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT04195555) enrolled 3 children or adolescents with a type of cancer that had come back or stopped responding to previous treatment. All 3 participants were given the drug ivosidenib. The main thing the trial was designed to measure was how many participants had their tumour shrink or disappear — known as the "objective response rate." None of the 3 participants completed the study. The reported data shows that, for the primary outcome, 0% of participants had their tumour shrink or disappear while on ivosidenib. For the secondary outcomes — which were intended to look at how long participants went without their disease getting worse, how many experienced serious side effects (graded as severe or higher), and how the drug moved through and acted in the body — no results were reported in the submitted data. The data was not reported for these secondary measures, so no numbers are available to describe. It is worth noting that with only 3 participants enrolled and none completing the study, the reported data is extremely limited, and the trial appears to have stopped early. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05321082 · results posted 9 January 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05321082) enrolled 1,178 people across three groups: 393 received a placebo (dummy treatment), 393 received a lower dose of nerandomilast (9 mg), and 392 received a higher dose (18 mg). The trial ran for up to 52 weeks and was primarily measuring changes in lung capacity — specifically a breathing test called forced vital capacity (FVC), which measures how much air a person can breathe out forcefully. This test is commonly used to track lung function in people with fibrosing interstitial lung disease (scarring of the lung tissue). Several secondary outcomes were also tracked, including hospitalisations for breathing problems, sudden worsening of lung disease, and deaths. The reported data shows that for the primary measure — change in FVC in millilitres (mL) at 52 weeks — all three groups showed a decline from their starting point. The placebo group's lung capacity declined by an average of about 166 mL, while the 9 mg nerandomilast group declined by about 85 mL, and the 18 mg group declined by about 99 mL. Similarly, when lung capacity was measured as a percentage of what would be expected for a healthy person, the placebo group declined by about 4.9 percentage points, compared to about 2.7 points in the 9 mg group and about 2.9 points in the 18 mg group. The reported data for secondary outcomes shows that 64 people in the placebo group died during the trial, compared with 36 in the 9 mg group and 34 in the 18 mg group. For hospitalisations due to breathing problems or death combined, 113 placebo participants experienced at least one of these events, versus 90 in the 9 mg group and 94 in the 18 mg group. For the broader combined measure of serious lung worsening, hospitalisation for breathing reasons, or death, 82 placebo participants, 70 in the 9 mg group, and 74 in the 18 mg group experienced at least one such event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04071769 · results posted 2 January 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people who had been newly diagnosed with idiopathic pulmonary fibrosis (IPF) — a condition where the lungs gradually become scarred and stiff. The trial was measuring changes in how well the lungs transfer oxygen into the bloodstream, using a specialised type of MRI scan that uses inhaled xenon gas, as well as standard breathing tests. Of the 34 people who started the trial, 21 completed it and 13 did not. The reported data shows that the primary measurement — called the RBC:barrier ratio, which is a score from a xenon MRI scan reflecting how efficiently oxygen moves from the air sacs in the lungs into the blood — was recorded at four points during the study. The reported values were 0.250, 0.237, 0.246, and 0.256. For context, a lower ratio is described in the trial as suggesting less efficient gas transfer. For the secondary measurements, the trial also tracked changes in two standard lung function tests over time. The reported changes in forced vital capacity (FVC, the maximum amount of air someone can forcefully breathe out) were 0.073, 0.063, and 0.190 litres across three time points. The reported changes in a test called DLCO (which measures how well a gas moves from the lungs into the bloodstream) were 0.026, −0.029, and −0.306 units across three time points. No further breakdown of these figures — such as what time points they correspond to — was 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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NCT02615938 · results posted 3 December 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT02615938) involved 35 children in total across four groups, studying a medicine called hydroxychloroquine (HCQ) for a rare childhood lung condition. The trial had two main phases: a "start" phase, where some children began on HCQ and others began on a placebo (a dummy treatment with no active ingredient), and a "stop" phase, where some children stopped taking HCQ and others stopped taking a placebo. The primary thing being measured was whether a child's breathing changed meaningfully — defined as a shift of 5% or more in blood oxygen levels, a 20% or more change in breathing rate, or a change in how much breathing support they needed. The reported data shows that for the primary outcome, very few participants met the threshold for a meaningful change in oxygenation. In the "start" groups during the first period, 0 out of 17 children starting on placebo and 0 out of 9 children starting on HCQ met that threshold; in the second period, 3 and 0 participants respectively did. In the "stop" groups, 0 and 0 met the threshold in the first period, and 1 and 1 did in the second period. For a secondary measure using a slightly lower threshold (a 3% change in oxygen levels rather than 5%), similar small numbers were reported across the groups. The reported data also shows small changes in blood oxygen percentage and breathing rate across the groups, with figures varying between a decrease of around 3.7 and an increase of around 13.8 breaths per minute depending on the group and period. Quality-of-life scores — measured on a 0–100 scale where higher means better — showed modest changes in both directions across the groups, ranging roughly from about −9.5 to +9.2 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT05032066 · results posted 3 December 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05032066) enrolled 153 people with idiopathic pulmonary fibrosis (IPF) — a condition that causes scarring of the lungs. Participants were split into three groups: one group received a lower once-daily dose of a drug called HZN-825 before switching to a higher twice-daily dose, a second group received the higher twice-daily dose throughout, and a third group received a placebo (dummy treatment) before also switching to the higher twice-daily dose. The trial's main measurement was lung function, specifically something called FVC % predicted — essentially how much air a person can forcefully breathe out compared to what would be expected for someone of the same age, sex, height and ethnicity. A higher number means better lung function; a lower (more negative) change means a decline. The reported data shows that over the first 52 weeks (the core phase), all three groups showed a decline in lung function from where they started. The once-daily-then-twice-daily group declined by about 4.1 percentage points, the twice-daily group by about 3.4 percentage points, and the placebo-then-twice-daily group by about 3.0 percentage points. For the number of participants whose lung function dropped by 10 percentage points or more, the reported data shows 6 people in the once-daily-then-twice-daily group, 7 in the twice-daily group, and 4 in the placebo-then-twice-daily group. In the extension phase out to 104 weeks, the reported numbers varied considerably across the three groups — an increase of about 11.4 percentage points, a decline of about 0.6 percentage points, and a decline of about 2.6 percentage points respectively — though it is worth noting that very few participants completed this longer phase (4, 5, and 6 people in each group). For the secondary measures — including a six-minute walking test, and two quality-of-life questionnaires about symptoms and daily impacts — mixed changes from baseline were reported across all groups, with some groups showing small improvements and others small declines in scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05938920 · results posted 2 December 2025

According to the results reported on ClinicalTrials.gov, this trial looked at an investigational medicine called INS018_055, tested in three different doses and schedules — 30 mg once a day, 30 mg twice a day, and 60 mg once a day — compared against a placebo (a dummy treatment with no active ingredient). A total of 71 people took part across the four groups, with numbers starting between 17 and 18 per group. Not everyone finished the study: by the end, 16 people completed the once-daily 30 mg group, 14 the twice-daily 30 mg group, 13 the 60 mg once-daily group, and 16 the placebo group. The trial's main focus was tracking unwanted medical events (called treatment-emergent adverse events, or TEAEs) that occurred during or shortly after the treatment period. It also measured changes in lung function using a standard breathing test called FVC (forced vital capacity), which estimates how much air a person can breathe out forcefully. The reported data shows that TEAEs were recorded across all groups: 13 out of 18 participants in the 30 mg once-daily group, 15 out of 18 in the 30 mg twice-daily group, 15 out of 18 in the 60 mg once-daily group, and 12 out of 17 in the placebo group experienced at least one such event. For lung function, the reported data shows the following changes in FVC from the start of the study to week 12: the 30 mg once-daily group showed a small decrease of about 0.79%, the 30 mg twice-daily group showed a small increase of about 0.68%, the 60 mg once-daily group showed an increase of about 3.23%, and the placebo group showed a small decrease of about 0.71%. In terms of actual volume (litres), these changes were −0.027 L, +0.020 L, +0.098 L, and −0.020 L respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03422068 · results posted 28 November 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people in total — 5 received a placebo (a dummy treatment with no active ingredient) and 10 received the study drug, BI 1015550, at an 18 mg dose. All 5 people in the placebo group finished the trial, while 8 out of 10 in the drug group completed it, with 2 not completing. The trial was primarily measuring how often participants experienced unwanted events (called adverse events) that were considered related to the study drug. The reported data shows that 90% of participants in the BI 1015550 group (9 out of 10 people) experienced at least one drug-related adverse event during the treatment period, compared with 60% in the placebo group (3 out of 5 people). The trial also measured how the drug moved through the body over time — specifically, how much of the drug was present in the blood and what the peak blood levels were. On the first day of dosing, the reported peak blood level of BI 1015550 was 277 nanomoles per litre, and the overall amount in the blood across the dosing period was 1,990 nanomole-hours per litre. By day 14, when blood levels had stabilised (meaning the drug had built up to a consistent level), the peak blood level was reported as 460 nanomoles per litre, and the overall amount across the dosing period was 3,720 nanomole-hours per litre. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05497284 · results posted 18 September 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05497284) enrolled 46 people in total — 23 received a treatment called LTP001 (at a 6mg dose) and 23 received a placebo (a dummy treatment with no active ingredient). The trial was looking at changes in lung function over a treatment period, primarily by measuring something called Forced Vital Capacity (FVC) — which is simply the total amount of air a person can breathe out in one go — expressed as a percentage compared to what would be expected for someone of a similar age, sex, and body size. By the end of the study, 15 people in the LTP001 group and 17 in the placebo group had completed the trial. The reported data shows that, on the primary measure, lung function (FVC as a percentage of predicted) declined in both groups by the end of the treatment period — by an average of 3.1 percentage points in the LTP001 group and 1.1 percentage points in the placebo group. For the secondary measures, the reported data shows the actual volume of air exhaled (FVC in millilitres) also fell in both groups — by an average of 120 mL in the LTP001 group and 45.5 mL in the placebo group. A separate secondary measure looked at how long participants went before experiencing a significant decline in lung function, hospitalisation, lung transplant, or death — the reported median time to such an event was 185 days in both groups. Six participants in the LTP001 group and five in the placebo group experienced a drop of 10% or more in their predicted FVC. The reported data also shows a separate measure of how well the lungs transfer gas into the bloodstream (DLCO) declined slightly less in the LTP001 group (−0.167 units) than in the placebo group (−0.334 units). Finally, on a six-minute walking distance test, the LTP001 group reported an average increase of 9.2 metres and the placebo group an average increase of 4.7 metres from the start of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05321069 · results posted 12 September 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,177 people with idiopathic pulmonary fibrosis (IPF) — a condition where the lungs gradually scar over time. Participants were divided into three groups: 393 received a placebo (dummy pill), 392 received a lower dose of nerandomilast (9 mg twice daily), and 392 received a higher dose (18 mg twice daily). The main thing the trial was measuring was the change in "forced vital capacity" (FVC) — a breathing test that measures how much air a person can breathe out in one go — after 52 weeks. Several other outcomes were also tracked, including hospital admissions for breathing problems, sudden worsening of the lung disease, and death. The reported data shows that after 52 weeks, all three groups showed a decline in their FVC breathing test scores from where they started. The placebo group's average score fell by about 183 millilitres (mL), the lower-dose nerandomilast group's fell by about 139 mL, and the higher-dose group's fell by about 115 mL. For the secondary outcomes, the reported data shows that the number of participants who experienced a serious event (sudden worsening of disease, respiratory hospitalisation, or death) was 38 in the placebo group, 32 in the lower-dose group, and 38 in the higher-dose group. Across the other secondary measures — such as significant drops in breathing test scores or a lung gas-transfer test (DLCO) — the numbers of participants experiencing those events were broadly similar across all three groups, as detailed in the full trial record. 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 ↗
NCT04533022 · results posted 23 May 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04533022) enrolled 52 participants, all of whom received a treatment called C21 at a dose of 100 mg twice daily. Of the 52 who started, 27 completed the trial and 25 did not finish. The trial was measuring unwanted health events (called adverse events) that occurred during the study period, as well as changes in a breathing test called Forced Vital Capacity (FVC) — a measure of how much air a person can breathe out in one breath — and the levels of C21 in participants' blood. The reported data shows that, out of 52 participants in the safety group, 37 experienced at least one adverse event during the trial. Five participants had a serious adverse event, six withdrew from the trial due to an adverse event, and 12 stopped taking the treatment due to an adverse event. Three participants had a treatment-related adverse event that led to stopping treatment, two participants died during the trial period, and no participants had a serious treatment-related adverse event. Regarding the breathing test, the reported data shows mixed results depending on how missing data was handled. When missing data was not filled in (non-imputed), the average change in FVC from the start of the trial was −4.9 mL at 12 weeks, +16.0 mL at 24 weeks, and +216.0 mL at 36 weeks. When missing data was estimated and filled in (imputed), the average changes were −57.6 mL, −70.3 mL, and +9.4 mL at those same time points. Blood levels of C21 were also measured in a smaller group of participants at the start of the trial and again at 12 weeks, with the reported figures varying across different time points after each 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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NCT05065190 · results posted 20 May 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05065190) enrolled 81 people in total — 27 received a placebo (an inactive treatment) and 54 received 150 mg of a medicine called nintedanib. The trial ran for 52 weeks and was primarily measuring how quickly lung capacity — specifically a measure called Forced Vital Capacity (FVC), which is the amount of air a person can forcefully breathe out — changed over that period. The reported data shows that lung capacity declined in both groups over the 52 weeks. In the placebo group, the average annual rate of decline in FVC was reported as approximately 192 millilitres per year. In the nintedanib group, the reported average annual rate of decline was approximately 85 millilitres per year. It is worth noting that not everyone completed the trial — 7 out of 27 people in the placebo group and 22 out of 54 people in the nintedanib group did not finish the study. The data collected after people stopped treatment was still included in the analysis. 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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NCT02496585 · results posted 16 April 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT02496585) involved 34 people in total. Nineteen participants received nintedanib combined with prednisone, and fifteen received a placebo combined with prednisone. The trial was measuring how many people in each group remained free from serious lung flare-ups (called pulmonary exacerbations) — defined as a worsening of symptoms such as cough, breathlessness, or low oxygen levels lasting more than four days, along with new abnormalities visible on a chest scan. The reported data shows that, among those who received nintedanib plus prednisone, 72% were free from these lung flare-ups over the course of the study. In the placebo plus prednisone group, 40% were free from flare-ups. It is worth noting that fewer people completed the study in the nintedanib group (9 out of 19) compared to the placebo group (12 out of 15), and no additional outcome measures were reported in the submitted data. No other outcome measure results were included in the data submitted to ClinicalTrials.gov, so further details about secondary findings cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04308681 · results posted 24 February 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04308681) enrolled people with two types of serious lung scarring conditions: idiopathic pulmonary fibrosis (IPF) and progressive fibrosing interstitial lung disease (PF-ILD). Participants were randomly assigned to receive either a placebo (inactive treatment) or one of two doses of the investigational medicine BMS-986278 (30 mg or 60 mg). In the IPF group, 93 people started in each of the placebo and 60 mg arms, and 92 in the 30 mg arm. In the PF-ILD group, 41 started on placebo and 42 each in the two active dose arms. The main thing being measured was a lung function test called "percent predicted forced vital capacity" (ppFVC) — essentially how much air participants could breathe out forcefully, expressed as a percentage of what would be expected for a healthy person of similar age and size, and how that changed over 26 weeks. The reported data shows that, for the IPF group at 26 weeks, lung function as measured by ppFVC declined in all three groups. The placebo group showed an average change of approximately −2.8%, the 30 mg BMS-986278 group showed approximately −3.1%, and the 60 mg BMS-986278 group showed approximately −1.1%. No ppFVC figures were reported for the PF-ILD cohort in the primary outcome data. For the secondary outcomes tracking unwanted medical events, the reported data shows that in the IPF group, 74 of 92 placebo participants, 69 of 91 in the 30 mg group, and 69 of 93 in the 60 mg group experienced at least one adverse event (an unexpected or worsening medical occurrence). Serious adverse events (those resulting in hospitalisation or considered life-threatening) were reported in 16 placebo, 10 in the 30 mg, and 10 in the 60 mg IPF participants. Deaths during the treatment period were reported in 2 placebo, 3 in the 30 mg, and 4 in the 60 mg participants in the IPF group, and in 3 placebo participants in the PF-ILD group, with none reported in either BMS-986278 dose groups in PF-ILD. 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 ↗
NCT05130970 · results posted 13 December 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT05130970) enrolled 81 people in total — 40 received a medicine called garadacimab and 41 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring certain medical events that occurred after participants started taking their assigned treatment, including serious medical events, specific events of special concern (such as unusual bleeding, blood clots, or severe allergic reactions), and whether participants' bodies developed antibodies against the study medicine. The reported data shows that serious medical events occurred in 5 out of 40 people (12.5%) in the garadacimab group and 2 out of 41 people (4.9%) in the placebo group. For the specific events of special concern — which included unusual bleeding, blood clots, and severe allergic reactions — the reported data shows these occurred in 2 out of 40 people (5.0%) in the garadacimab group and in none of the people in the placebo group. Regarding antibodies that the body might produce in response to the study medicine, the reported data shows that approximately 2.6% of participants in the garadacimab group and between 2.8% and 5.4% of participants in the placebo group showed this type of immune response, though the data submission included multiple measurements for this outcome and the figures varied slightly across those 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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NCT05870956 · results posted 1 October 2024

According to the results reported on ClinicalTrials.gov, this study looked at 1,798 people in total who had been prescribed a medicine called nintedanib (used for a lung condition called idiopathic pulmonary fibrosis, or IPF — a progressive scarring of the lungs). Participants were grouped based on how consistently they took their medication over time: "High Adherence" (781 people), "Moderate Adherence" (202 people), "High-then-Poor Adherence" (190 people), "Delayed-Poor Adherence" (255 people), and "Early-Poor Adherence" (370 people). The study measured healthcare costs and hospital admission rates across these groups during the first year of treatment, using Medicare records in the United States. The reported data shows that total medical costs (not including the cost of the prescription itself) varied across the groups. The High Adherence group had average costs of around US$12,648 per person, while the Early-Poor Adherence group had the highest average costs at around US$18,110 per person. When looking only at costs related to IPF specifically, the High-then-Poor Adherence group had the highest average at around US$6,012 per person, compared to around US$3,240 for the High Adherence group. For hospital admissions, the reported data shows that 20.4% of the High Adherence group had at least one hospital stay for any reason, compared to 30.0% in the High-then-Poor Adherence group. For IPF-related hospital admissions specifically, the figures ranged from 10.8% in the High Adherence group to 19.5% in the High-then-Poor Adherence 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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NCT05875532 · results posted 19 September 2024

According to the results reported on ClinicalTrials.gov, this study enrolled 34,960 participants, all of whom had been diagnosed with a type of scarring lung disease (interstitial lung disease, or ILD) other than the most common form known as IPF. The study was observational, meaning researchers looked back at existing medical records rather than testing a new treatment. The main goal was to track how likely these patients were to have their lung disease worsen — described as "progression to pulmonary fibrosing ILD" — over a period of up to two years after their diagnosis. The reported data shows that the estimated likelihood of disease progression increased over time. By 6 months after diagnosis, approximately 14.7% of patients had shown signs of progression; by 12 months that figure rose to around 24.9%; by 18 months it was approximately 33.4%; and by 24 months it reached around 39.5%. These percentages are statistical estimates (meaning they are calculated approximations of risk across the whole group, not exact counts). The study also tracked what treatments and disease management approaches patients received during the follow-up period. Among the secondary findings, the reported data shows that oral corticosteroids were the most commonly recorded treatment, used by 2,065 participants, while nintedanib (a specific lung medication) was recorded for 472 participants. For disease management, oxygen therapy was recorded for 1,641 participants, palliative care measures for 9,520 participants, and no lung transplants were recorded in this 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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NCT03955146 · results posted 19 September 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03955146) looked at a drug called pamrevlumab compared to a placebo (an inactive treatment) in people with idiopathic pulmonary fibrosis (IPF) — a condition where the lungs gradually scar and stiffen over time. The main thing the trial measured was how much lung capacity changed over 48 weeks, using a breathing test called FVC (Forced Vital Capacity), which measures how much air a person can forcefully breathe out. The trial included two groups: a main study group of 356 people (181 received pamrevlumab, 175 received placebo), and a smaller Japan-based group of 37 people (18 received pamrevlumab, 19 received placebo). After the initial 48-week period, 252 participants from the main group continued into a longer follow-up phase. The reported data shows that in the main study group, lung capacity (FVC) declined by an average of 0.26 litres in those taking pamrevlumab and 0.33 litres in those taking placebo over 48 weeks — both groups experienced a reduction, just of different sizes. In the Japan group, the reported decline was 0.04 litres for pamrevlumab and 0.18 litres for placebo. The reported data also shows that for the secondary measures — such as time until disease got significantly worse or a serious event like hospitalisation or death occurred — the pamrevlumab group had an estimated median of 54.3 weeks before disease progression, compared to 50.7 weeks for placebo. For the combined measure of serious events (acute worsening, hospitalisation, or death), the median time was estimated at 62.7 weeks for the pamrevlumab group, while a median was not able to be calculated for the placebo group based on the available data. Lung scarring (measured by a scan-based score called QLF volume) increased in both groups over 48 weeks, with the main study pamrevlumab group showing a rise of 251 mL compared to 268 mL 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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NCT04419558 · results posted 12 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04419558) enrolled 184 people in the pamrevlumab group and 188 in the placebo group for a 48-week double-blind period, followed by an open-label extension phase of another 48 weeks. The trial was measuring things related to idiopathic pulmonary fibrosis (IPF) — a condition that causes scarring in the lungs. The main thing researchers were tracking was a breathing test called forced vital capacity (FVC), which measures how much air a person can forcibly breathe out. They also tracked how long it took for the disease to progress, changes in the amount of scarring visible in the lungs, hospitalisations, flare-ups, and deaths. The reported data shows that for the primary measure — change in FVC (lung air volume) over 48 weeks — the pamrevlumab group showed an average decline of 0.30 litres, while the placebo group showed an average decline of 0.33 litres. For the time-to-disease-progression measure (defined as a significant drop in lung function or death), the reported median time was 59 weeks for the pamrevlumab group; a median figure for the placebo group was not reported, which the trial notes can occur when fewer than half of participants in that group reached that point within the study timeframe. The reported data shows that average lung scarring volume increased by approximately 255 millilitres in the pamrevlumab group and 269 millilitres in the placebo group. For several other secondary measures — including time to a serious clinical event (hospitalisation, flare-up, or death), time to first flare-up, and time to death from any cause in the pamrevlumab group — median figures were not reported, again noted as potentially meaning the event was not reached within the 48-week period. A median time to death of 62.9 weeks was reported for the placebo group only. It is also worth noting that a large number of participants did not complete the double-blind period — 137 in the pamrevlumab group and 132 in the placebo group — and no participants completed the open-label extension phase, which may be relevant context when reading these numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03710824 · results posted 31 July 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 180 people who had been diagnosed with idiopathic pulmonary fibrosis (IPF) — a condition where the lungs progressively scar over time. All participants received the medication nintedanib. The trial was measuring several things over a follow-up period, including quality of life, breathlessness, cough, anxiety, how consistently participants took their medication, and how many were using long-term oxygen. Of the 180 who started, 149 completed the study and 31 did not. The reported data shows the following across the measured time points. For the primary outcome — quality of life using a respiratory questionnaire (where higher scores mean worse quality of life) — the change from the starting score across the four reported time points was +2.08, −2.31, +3.37, and +2.88. For breathlessness (rated on a 0–4 scale, with 4 being most severe), the reported changes from baseline were +0.30, +0.31, +0.40, and +0.39. For cough (rated 0–100, where lower numbers mean more intense cough), the changes were −0.72, −3.73, −2.13, and −1.25. For anxiety scores, the changes were +0.09, +0.48, +0.77, and +0.97. Regarding how consistently participants took their medication, between approximately 71% and 77% were classed as adherent across the time points. The percentage of participants using long-term oxygen ranged from around 15% to 18% across the five reported 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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NCT03832946 · results posted 22 May 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03832946) compared an inhaled investigational medicine called GB0139 (taken as a 3 mg once-daily dose) against a placebo (a dummy treatment with no active ingredient) in people with a lung condition called idiopathic pulmonary fibrosis (IPF). A total of 102 people were assigned to the GB0139 group and 70 to the placebo group. The trial's main goal was to measure how quickly lung function — specifically a breathing test result called Forced Vital Capacity (FVC), which measures the amount of air a person can breathe out — changed over the course of the study. Not all participants finished the trial: 55 in the GB0139 group and 38 in the placebo group completed it. The reported data shows that, on average, FVC declined by about 317 mL per year in the GB0139 group and about 127 mL per year in the placebo group. Regarding hospital admissions related to breathing problems (including flare-ups of IPF), the reported data shows 17 participants in the GB0139 group and 5 participants in the placebo group experienced at least one such hospitalisation. The trial also measured quality of life related to breathing using a standardised questionnaire (scored from 0 to 100, where a higher score means worse quality of life). The reported data shows the GB0139 group's score increased by approximately 4.2 points from the start of the study to week 52, while the placebo group's score decreased by approximately 4.8 points — meaning, on that scale, the placebo group's reported quality of life appeared to improve slightly while the GB0139 group's appeared to worsen slightly. It is worth noting that the data as submitted does not include additional statistical context (such as confidence intervals or adjusted analyses) that researchers would typically use to interpret these numbers more fully. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04594707 · results posted 16 May 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04594707) involved 117 participants across three groups. Twenty-one people were in Cohort A, who received a medicine called zinpentraxin alfa from the start. The remaining 96 participants were split into two groups in Cohort B: 49 who had previously received a placebo (a dummy treatment) and 47 who had previously received zinpentraxin alfa. The trial was measuring things like unwanted medical events (called adverse events), reactions during the medicine drip (infusion-related reactions), and changes over time in lung function and walking ability. The reported data shows that, when it came to adverse events, 18 out of 21 participants in Cohort A experienced at least one, compared with 25 out of 49 in the Cohort B ex-placebo group and 26 out of 47 in the Cohort B zinpentraxin alfa group. Reactions during or shortly after the drip were reported in 2, 2, and 4 participants across the three groups respectively. A small number of participants — 2, 2, and 1 across the three groups — stopped taking the study medicine permanently because of an adverse event. It is worth noting that the reported data shows zero participants in any group completed the study, meaning all participants left before the study finished; the reasons for this were not detailed in the submitted data. For the secondary measures, the reported data shows changes in lung capacity (measured as forced vital capacity, or how much air someone can breathe out) over a year: Cohort A lost an average of about 229 mL, the Cohort B ex-placebo group lost about 273 mL, and the Cohort B zinpentraxin alfa group lost about 121 mL. For the six-minute walk test — how far someone can walk in six minutes — Cohort A showed an average decrease of about 87 metres per year, while the Cohort B ex-placebo group showed an average increase of about 65 metres, and the Cohort B zinpentraxin alfa group showed an average decrease of about 164 metres. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04396756 · results posted 30 April 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04396756) tested a drug called PLN-74809 across four parts (A, B, C, and D), using different doses: 40 mg, 80 mg, 160 mg, and 320 mg. In total, 120 people took part — 1 person in Part A (40 mg), 22 in Part B (40 mg), 23 in Part C (80 mg), 22 in Part C (160 mg), 21 in Part D (320 mg), and 31 who received a placebo (a dummy treatment with no active ingredient). The trial's primary focus was on tracking "treatment-emergent adverse events" — that is, any unwanted medical occurrences that happened after participants started taking the study drug — as well as more serious versions of these events. The reported data shows the following numbers of participants who experienced these unwanted medical occurrences. In Part A (1 person on 40 mg), 1 person had a treatment-emergent adverse event, and none had a serious one. In Parts B, C, and D combined, the reported numbers were: 16 out of 22 people on 40 mg, 15 out of 23 on 80 mg, 14 out of 22 on 160 mg, and 17 out of 21 on 320 mg; in the placebo group for those parts, 21 out of 31 people had such an event. For serious adverse events in that same grouping, the numbers were 1, 0, 2, and 1 respectively across the dose groups, and 3 in the placebo group. Part D (320 mg) was also reported separately: 20 out of 21 participants on the drug and 7 out of 10 placebo participants had a treatment-emergent adverse event, while serious adverse events were reported in 2 and 1 participants respectively. No secondary outcome measure data was included in the submitted results. The reported data does not include secondary outcome results, so those figures cannot be described here. These numbers reflect only what was counted and recorded during the trial period, and no conclusions about cause or broader meaning should be drawn from them 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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NCT05022784 · results posted 19 April 2024

According to the results reported on ClinicalTrials.gov, this study enrolled 1,798 people who had been diagnosed with idiopathic pulmonary fibrosis (a scarring lung condition) and had started taking a medicine called nintedanib. All 1,798 participants completed the study. The main thing the trial was looking at was how consistently patients took their nintedanib over 12 months — specifically, whether people kept filling their prescriptions regularly over time, and whether different patterns of medicine-taking could be identified among the group. The reported data shows that researchers identified five distinct patterns of medicine-taking. The largest group — 781 people — was classed as "highly adherent," meaning they consistently had their prescription covered for roughly 90% of days over the 12 months. A further 202 people were classed as "medium adherent," with coverage of around 40–60% of days. The remaining participants showed declining patterns over time: 190 were "gradual decliners" (whose coverage dropped off by around month 11), 255 were "intermediate decliners" (coverage dropping by around month 8), and 370 were "rapid decliners" (coverage falling close to zero by around month 4). The reported data also shows that the average age across all five groups was similar, ranging from about 74.6 to 76.3 years, and that male participants outnumbered female participants in every group. The secondary results reported on ClinicalTrials.gov also looked at characteristics such as sex, race, location, and a measure of social disadvantage (called the Social Deprivation Index, which scores areas from 0 to 100 based on factors like poverty and education — higher scores meaning more disadvantage). The reported Social Deprivation Index scores were broadly similar across all five groups, ranging from about 39 to 42, though this data related to a US population and may not reflect other countries. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04552899 · results posted 18 April 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04552899) enrolled 331 people in the zinpentraxin alfa group and 333 people in the placebo group — a total of 664 participants. The trial was measuring changes in lung function and physical ability over time in people with a serious lung condition. The main thing being tracked was a breathing test called Forced Vital Capacity (FVC), which measures how much air a person can breathe out. A smaller number (a bigger drop) means lung function has declined more. The reported data shows that, on average, lung capacity (FVC) fell by about 236 millilitres in the zinpentraxin alfa group and about 215 millilitres in the placebo group over the course of the study. For the secondary measures — other things the trial was also tracking — the reported data shows that the distance participants could walk in six minutes fell by about 34 metres in the zinpentraxin alfa group and about 24 metres in the placebo group. The time until the disease was recorded as getting worse was reported as 6.6 months for the zinpentraxin alfa group and 8.2 months for the placebo group. Figures for time to first hospitalisation due to breathing problems were not reported in the submitted data. Changes in a breathlessness questionnaire (where higher scores mean more severe breathlessness) were also measured at several points during the study, with scores broadly similar between the two groups at most time points, though the reported data shows some variation across different time points. It is also worth noting that a large proportion of participants — around 275 in the zinpentraxin alfa group and 284 in the placebo group — did not complete the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04525547 · results posted 12 March 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04525547) enrolled 70 participants, all of whom received the treatment being studied — a medication called Ofev (nintedanib). Of those 70 people, 65 completed the trial and 5 did not. The trial was measuring two main things: how many participants experienced adverse events (unwanted health events recorded during the study), and how a lung function measurement called Forced Vital Capacity (FVC) changed over time. FVC is simply a measure of how much air a person can forcefully breathe out in one go, recorded in millilitres (mL). The reported data shows that 36 out of 70 participants experienced at least one adverse event while taking Ofev. Regarding lung function, the reported data shows that the average FVC measurement changed by minus 15 mL after 12 weeks of treatment compared to where participants started — meaning, on average, the group's FVC was slightly lower than at the beginning. After 24 weeks, the reported average change was minus 44 mL compared to the starting point. The trial did not appear to include a comparison group (such as a placebo group), so these numbers reflect only the single group of participants who took Ofev. No secondary outcome measure data was reported in the structured 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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NCT03313180 · results posted 20 February 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03313180) enrolled 444 participants, all of whom received a medicine called nintedanib. The trial was a single-group study, meaning everyone received the same treatment with no comparison group. The main thing the trial set out to measure was how many participants experienced any unwanted or unexpected health event (called an "adverse event") during the course of the study. Of the 444 people who started, 265 completed the trial, while 179 did not finish — the reasons for not completing were not detailed in the data provided here. The reported data shows that, out of the 444 participants who started, 441 experienced at least one adverse event during the trial. This was the only outcome measure included in the results data submitted to ClinicalTrials.gov for this trial. No further breakdown of the types, severity, or details of those events was included in the data provided, and no other outcome measures — such as measures of how well the medicine may or may not have worked — were reported in the structured results available. It is worth noting that in trials like this one, tracking adverse events is a standard and important part of understanding what happens to participants during a study — it does not on its own tell us whether a treatment is beneficial or harmful overall. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03641742 · results posted 18 November 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03641742) involved two groups of participants: 27 people who had already been diagnosed with a familial form of interstitial lung disease (a condition where lung tissue becomes damaged or scarred) — referred to as "proband" participants — and 98 people considered "at-risk" because of a family connection to someone with the condition. All 125 participants who started the trial completed it, with no drop-outs recorded. The trial was looking at whether certain lung changes, called interstitial lung abnormalities (ILAs), could be spotted on CT chest scans in the at-risk group. The reported data shows that the primary outcome — identifying ILAs on CT chest scans, as assessed by a specialist radiologist — was measured in the 98 at-risk participants. Of this group, 85 participants showed no ILAs on their scans, while 13 participants did show ILAs. No additional outcome measures beyond this count were reported in the submitted results data. It is worth noting that the reported results cover only this one primary outcome measure, and no secondary outcome data appears to have been submitted to ClinicalTrials.gov for this 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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NCT03727802 · results posted 23 October 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03727802) tested a medicine called TRK-250 across two parts (Part A and Part B). In Part A, small groups of three to four participants each received one of four different doses of TRK-250 (2 mg, 10 mg, 30 mg, or 60 mg), while four participants received a placebo (a dummy treatment with no active ingredient). In Part B, groups of four participants received one of three doses of TRK-250 (10 mg, 30 mg, or 60 mg), and six participants received a placebo. In total, 34 people started the trial, and 32 completed it — one person in the Part B 60 mg group and one in the Part B placebo group did not finish. The primary outcome — meaning the main thing the trial set out to measure — was the number of participants who experienced adverse events (unwanted or unexpected health occurrences) and how severe those were. The reported data shows that in Part A, 1 participant in the 2 mg group, 0 in the 10 mg group, 3 in the 30 mg group, 2 in the 60 mg group, and 1 in the placebo group reported adverse events. In Part B, 3 participants in the 10 mg group, 2 in the 30 mg group, 3 in the 60 mg group, and 3 in the placebo group reported adverse events. Some severity-level figures were partially reported (for example, 2 participants in the Part A 30 mg group were noted at a particular severity level), but the remaining severity breakdown data was not fully 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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NCT04275297 · results posted 8 August 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04275297) enrolled 78 people in total — 52 in a psychosocial treatment group and 26 in an attention control group (a comparison group that received a different level of contact but not the main treatment being studied). Nearly all participants finished the trial: 51 out of 52 in the treatment group and 25 out of 26 in the control group. The trial was measuring changes in pelvic and urinary pain symptoms, as well as related conditions such as depression, widespread body pain, and post-traumatic stress symptoms, at two months and five months after the start of the study. The reported data shows that the main outcome — change in scores on the Genitourinary Pain Index (GUPI), a 0–35 scale where higher numbers mean worse symptoms — showed the following changes from the start of the study: at two months, the psychosocial treatment group reported a change of 6.6 points and the attention control group reported a change of 4.8 points; at five months, those figures were 8.1 and 6.6 points respectively. For the secondary outcomes, the reported changes in depression scores (0–24 scale), widespread body pain scores (0–19 scale), fibromyalgia symptom scores (0–12 scale), and post-traumatic stress scores (0–80 scale) were all relatively small numerical shifts across both groups at both time points, as listed in the submitted data. The direction of some of these changes varied between the two groups and between 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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NCT03142191 · results posted 28 June 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled participants across two related studies. In the main study (IPF Study), 39 people received CC-90001 at 200 mg, 37 received it at 400 mg, and 36 received a placebo (an inactive dummy treatment). A smaller sub-study (PPF Sub-Study) included 15 people on CC-90001 400 mg and 8 on placebo. The trial was measuring changes in lung function and other health indicators over time in people with serious lung scarring conditions. The main thing being tracked was a lung function measurement called Forced Vital Capacity (FVC) — essentially how much air a person can breathe out — expressed as a percentage of what would be expected for a healthy person of the same age and size. The reported data shows that, over the placebo-controlled period, the average change in percentage-predicted FVC was +0.5 percentage points for the 200 mg group, +0.6 percentage points for the 400 mg group, and −0.9 percentage points for the placebo group. In terms of the actual volume of air (measured in millilitres), the reported average changes from the start of the trial were −74.9 mL for the 200 mg group, −6.8 mL for the 400 mg group, and −88.3 mL for the placebo group. For the secondary measures, the reported data shows that around 23%, 27%, and 25% of participants in the 200 mg, 400 mg, and placebo groups respectively met the study's definition of disease progression. Changes in walking distance, breathlessness scores, and quality-of-life questionnaire scores were also recorded across multiple time points, with varying figures reported for each group; some of these data points were not fully reported for all time points and groups 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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NCT04093024 · results posted 31 January 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04093024) involved 39 children and teenagers who took part in the double-blind phase — 13 were randomly assigned to a placebo (an inactive treatment) and 26 were assigned to nintedanib, a medicine being studied for use in young people. The trial had two main phases: a double-blind period (where neither participants nor doctors knew who received which treatment) and an open-label period (where everyone received nintedanib). The trial was primarily measuring how much of the nintedanib medicine was absorbed into the bloodstream at a steady level, and also tracking how many participants experienced unexpected health events (called adverse events) during the study. The reported data shows that, for the drug absorption measure, children aged 6 to under 12 years had an average steady-state drug exposure level of 175 hours×ng/mL, and those aged 12 to under 18 years had a level of 167 hours×ng/mL (these figures describe how much medicine was present in the blood over time). Regarding unexpected health events during the double-blind period, 11 out of 13 participants in the placebo group and 22 out of 26 in the nintedanib group had at least one such event recorded. Over the whole trial, 11 placebo participants, 11 participants who later switched to nintedanib, and 26 participants originally assigned to nintedanib had at least one unexpected health event reported. The reported data also shows that secondary measures tracked changes in bone growth plates and dental findings. By week 52, 2 participants in the placebo group and 3 in the nintedanib group had at least one unexpected finding on bone growth plate imaging. For dental findings over the same period, 3 participants in the placebo group and 7 in the nintedanib group had at least one unexpected finding on dental examination, while 1 and 6 respectively had unexpected findings on dental imaging. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04419506 · results posted 1 November 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 147 people in total across four groups. Participants either received the investigational drug BI 1015550 or a placebo (a dummy treatment with no active ingredient), and were further divided based on whether they were already taking a type of lung-scarring medication called antifibrotics at the start of the trial. The trial was primarily measuring changes in lung capacity — specifically a breathing test called Forced Vital Capacity (FVC), which measures how much air a person can breathe out in one go — over 12 weeks. A secondary measure tracked how many participants experienced any unwanted health events (called adverse events) during the treatment period. The reported data shows that after 12 weeks, lung capacity (measured in millilitres) changed differently across the groups. Among those already on antifibrotics, the placebo group's FVC dropped by an average of about 78 millilitres, while the BI 1015550 group's FVC changed by an average of roughly +3 millilitres (a very small increase). Among those not on antifibrotics, the placebo group's FVC dropped by about 96 millilitres on average, while the BI 1015550 group's FVC changed by an average of about +6 millilitres. Regarding unwanted health events during treatment, the reported data shows these were recorded in 5 of 25 placebo participants and 18 of 49 BI 1015550 participants in the antifibrotics group, and in 5 of 25 placebo participants and 9 of 48 BI 1015550 participants in the non-antifibrotics group. It is worth noting that not everyone who started the trial completed it — 10 participants in the BI 1015550 antifibrotics group and 5 in the BI 1015550 non-antifibrotics group did not finish, though the reasons were not reported in this 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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NCT03711162 · results posted 29 July 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03711162) enrolled 525 people across three groups — 175 received a higher dose of GLPG1690 (600 mg), 175 received a lower dose (200 mg), and 175 received a placebo (a dummy treatment with no active ingredient). The trial ran for up to 52 weeks and was studying a condition affecting the lungs. The main thing it measured was how quickly lung capacity — specifically a breathing test called FVC (forced vital capacity), which measures the maximum amount of air a person can breathe out — declined over time. It is worth noting that the data shows zero participants were recorded as having "completed" the study, which may reflect that the trial was stopped early; no further explanation for this was provided in the reported data. The reported data shows that, over 52 weeks, lung capacity declined in all three groups. In the 600 mg group, the average decline was about 125 mL per year; in the 200 mg group it was around 174 mL per year; and in the placebo group it was around 147 mL per year. For the secondary outcomes, the percentage of participants whose disease progressed (defined as a significant drop in lung function or death) by week 52 was reported as 17.8% in the 600 mg group, 18.7% in the 200 mg group, and 18.3% in the placebo group. Respiratory-related hospitalisations were reported in approximately 9.5%, 9.4%, and 9.8% of participants in the 600 mg, 200 mg, and placebo groups respectively. A quality-of-life questionnaire (scored 0–100, where higher scores mean worse quality of life) showed scores increased — meaning quality of life worsened — by 3.3, 4.1, and 3.8 points in the three groups respectively. The reported data also shows that when disease progression was measured across the full study period (beyond week 52), the figures were 23.1% (600 mg), 24.6% (200 mg), and 21.3% (placebo), and the annual rate of lung capacity decline over the full study period was similarly reported as approximately 127 mL/year, 176 mL/year, and 146 mL/year for the three groups respectively. These numbers are simply what was recorded and reported — they do not on their own indicate whether any treatment performed better or worse than another without further statistical analysis, which was not included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00677560 · results posted 20 December 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 126 participants across five groups: 20 people with mild-to-moderate asthma, 23 with severe asthma, 29 people without any lung condition (normal subjects), 20 healthy smokers, and 34 people with a chronic lung condition called COPD (ranging from mild to moderately severe, known as Gold Stages I–III). It is worth noting that a large number of participants did not complete the study — for example, only 5 of the 20 mild-to-moderate asthma participants and only 6 of the 29 normal subjects finished. The trial was measuring several aspects of lung function and airway inflammation across these different groups. The reported data shows the following for the primary measure, FEV1 — the amount of air a person can forcefully breathe out in one second (a common measure of lung function): the COPD group recorded the lowest average at 1.67 litres, followed by the severe asthma group at 2.32 litres, healthy smokers at 2.76 litres, mild-to-moderate asthma at 3.03 litres, and normal subjects at 3.18 litres. For the secondary measures, the reported data shows that a gas called nitric oxide from the deep lung (Calv) ranged from 2.9 parts per billion in normal subjects up to 4.6 in healthy smokers. A measure of airway stiffness or resistance called AX was reported as highest in the COPD group (2.48 kPa/L) and lowest in normal subjects (0.55 kPa/L). Another resistance measure taken during breathing out (R5 EX) was highest in COPD (0.66) and lowest in normal subjects (0.45). Nitric oxide produced specifically from the airways (J'aw) was reported as highest in the mild-to-moderate asthma group at 138.5 nanolitres per second, compared with 35.4 in healthy smokers. Finally, a measure of uneven airflow within the smallest airways (Sacin) was reported as highest in the COPD group at 0.346 and lowest in normal subjects at 0.089. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02257177 · results posted 8 April 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02257177) tested an inhaled drug called TD139 across two parts. In total, 60 people took part — 24 in Part 1 (split across six different dose levels of TD139 plus a placebo group of 12), and 24 in Part 2 (split across three groups receiving different doses of TD139 or placebo). Nearly all participants completed the trial; only one person in the 10 mg TD139 group in Part 2 did not finish. The trial was measuring how many participants experienced adverse events — that is, any unwanted or unexpected health occurrences — in the 30 days following their first dose. The reported data shows that the number of participants who experienced at least one adverse event varied across the groups. In Part 1, no adverse events were reported in the two lowest dose groups (0.15 mg and 1.5 mg), while 2 out of 4 participants reported them in the 3 mg group, 3 out of 4 in the 10 mg group, and all 4 out of 4 in both the 20 mg and 50 mg groups. In the Part 1 placebo group, 2 out of 12 participants reported adverse events. In Part 2, the reported data shows 4 out of 5 in the 0.3 mg group, all 5 out of 5 in the 3 mg group, 4 out of 4 (who completed) in the 10 mg group, and 7 out of 9 in the Part 2 placebo group reported adverse events. It is worth noting that this trial only reported one outcome measure — the number of adverse events — and no other measurements (such as whether the drug had any effect on a disease) were included in the submitted results data. No secondary outcome data was reported on ClinicalTrials.gov for this 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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NCT03958071 · results posted 17 December 2020

According to the results reported on ClinicalTrials.gov, this study looked at real-world medical records of people diagnosed with idiopathic pulmonary fibrosis (IPF) — a condition that causes scarring of the lungs. A total of 13,264 people's records were included: 347 who had been treated with a medicine called nintedanib, 423 treated with pirfenidone (another medicine for IPF), and 12,494 who had not received either of these medicines. The study was not a traditional trial where people were randomly assigned to treatments; instead, it examined existing medical records to understand the characteristics of each group and what factors were associated with whether someone received treatment. The reported data shows that the three groups were broadly similar in age at the start of the observation period — the nintedanib group had an average age of 71.6 years, the pirfenidone group 72.1 years, and the untreated group 70.9 years. In terms of sex, the reported data shows that in the nintedanib group 234 participants were male and 113 female; in the pirfenidone group 281 were male and 142 female; and in the untreated group 6,179 were male and 6,314 female. Average body weight index (a measure comparing weight to height) was 29.5, 30.1, and 28.6 respectively across the three groups. A score measuring how many other health conditions participants had (called the Charlson Comorbidity Index, where a higher number means more conditions) was reported as 0.71 for the nintedanib group, 0.79 for the pirfenidone group, and 1.09 for the untreated group. The number of participants using inhaled corticosteroids (a type of anti-inflammatory medicine breathed in) before the study period began was 125, 134, and 3,311 across the three groups respectively. The reported data also includes a secondary analysis that used a statistical method (logistic regression — a way of estimating how strongly different factors are linked to an outcome) to look at which patient characteristics were associated with receiving treatment versus no treatment. The results were expressed as "odds ratios" — a number above 1 suggesting a characteristic was linked to a greater chance of receiving treatment, and below 1 suggesting a lesser chance. Twelve separate odds ratio figures were reported for the overall population, ranging from 0.383 to 1.833, each corresponding to a different patient characteristic; however, the data as submitted does not label which specific characteristic each individual number relates to, so a full breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03573505 · results posted 20 November 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03573505) enrolled 106 adults with idiopathic pulmonary fibrosis (IPF) — a condition that causes scarring of the lungs. Fifty-two participants were assigned to receive a placebo (an inactive treatment) and 54 received the investigational drug BG00011. The trial ran for 52 weeks and was primarily measuring changes in lung capacity — specifically a breathing test called Forced Vital Capacity (FVC), which measures how much air a person can breathe out forcefully. It is worth noting that the reported data shows zero participants were recorded as having "completed" the study, which may reflect an early stopping of the trial; no further explanation of this was provided in the submitted data. The reported data shows that at the start of the trial, average FVC was 2.883 litres in the placebo group and 2.867 litres in the BG00011 group. By week 52, the placebo group's FVC had declined by an average of 0.308 litres, while the BG00011 group's FVC had declined by an average of 0.455 litres. When lung capacity was expressed as a percentage of what would be expected for a healthy person of similar age and size, the placebo group declined by 7.6 percentage points on average, compared with 11.5 percentage points in the BG00011 group. For a secondary measure looking at how quickly participants reached a significant worsening point (such as a large lung function drop, hospitalisation, transplant, or death), the reported median time was 127.5 days in the placebo group and 119.0 days in the BG00011 group. The reported data also shows that 0 participants in the placebo group experienced an acute flare-up (sudden worsening) of their IPF, compared with 7 participants in the BG00011 group, accounting for 8 recorded flare-up events in total. The time-to-first-flare-up figure for the placebo group was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01890265 · results posted 4 September 2020

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called pamrevlumab compared to a placebo (an inactive dummy treatment) in people with a lung-scarring condition called idiopathic pulmonary fibrosis (IPF). In total, 103 people took part in the main comparison (50 receiving pamrevlumab and 53 receiving placebo), with additional smaller groups testing the drug alongside two other medicines, pirfenidone and nintedanib, bringing the overall number enrolled to 160. The main thing the trial was measuring was a breathing test called FVC (forced vital capacity) — essentially how much air a person can breathe out — tracking any change over 48 weeks. The reported data shows that at the start of the trial, both groups had similar FVC readings (around 74–75% of what would be expected for a person of their age, sex, and size). After 48 weeks, the pamrevlumab group's average FVC had fallen by about 2.7 percentage points, while the placebo group's had fallen by about 7.2 percentage points. For the lung scarring measured by chest scans, the reported data shows scarring increased by an average of 2.7% in the pamrevlumab group and 6.0% in the placebo group by week 48. Regarding disease progression events (defined as death or a significant drop in breathing capacity), 5 out of 50 participants in the pamrevlumab group and 16 out of 51 in the placebo group recorded such an event. For respiratory-related hospitalisations, 5 pamrevlumab participants and 7 placebo participants were reported; for respiratory-related deaths, 2 were reported in the pamrevlumab group and 3 in the placebo group. On a quality-of-life questionnaire (where higher scores mean worse health), the reported data shows that starting scores were similar between groups, and changes over 48 weeks were also broadly similar, with neither group showing large shifts in either direction. It is worth noting that these numbers describe what was measured and recorded in this particular group of trial participants 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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NCT02345070 · results posted 26 May 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 327 people across three groups to study a medicine called SAR156597 in people with Idiopathic Pulmonary Fibrosis (IPF), a condition that causes scarring of the lungs. One group received a placebo (a dummy treatment with no active ingredient) once a week, one group received SAR156597 at 200mg every two weeks, and one group received SAR156597 at 200mg once a week. The trial ran for 52 weeks and primarily measured changes in lung function over that time. The reported data shows that the main thing being measured was "percent predicted FVC" — a standard test of how much air a person can breathe out, adjusted for their age, height, and gender. A lower number means lung function has declined. By week 52, the placebo group showed an average decline of 5.81 percentage points, the every-two-weeks group showed a decline of 5.24 percentage points, and the once-a-week group showed a decline of 6.31 percentage points. For the secondary outcomes, the reported data shows the estimated probability of disease progression (meaning significant worsening, lung transplant, or death) by week 52 was 0.512 (about 51%) in the placebo group, 0.460 (about 46%) in the every-two-weeks group, and 0.537 (about 54%) in the once-a-week group. The estimated probability of death from any cause by week 52 was reported as 0.09 (9%) for the placebo group, 0.08 (8%) for the every-two-weeks group, and 0.13 (13%) for the once-a-week 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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NCT02858180 · results posted 21 April 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people with hepatitis C who also had serious underlying health conditions — 10 in a heart failure group and 5 in a lung disease group. The trial was looking at whether these participants could complete a full 24-week course of hepatitis C treatment, and also tracked whether the hepatitis C virus became undetectable in their blood after finishing treatment. All 10 people in the heart failure group and 3 of the 5 people in the lung disease group finished the study (the remaining 2 in the lung disease group did not complete it, though the reasons were not detailed in the data provided). The reported data shows that for the primary measure — completing the full 24 weeks of treatment — 0 out of 10 participants in the heart failure group and only 1 out of 5 in the lung disease group were recorded as having done so. For the secondary measures, the trial tracked whether the hepatitis C virus was undetectable in the blood at 4 weeks after finishing treatment and again at 12 weeks after finishing treatment. At 4 weeks post-treatment, 8 out of 10 people in the heart failure group and 3 out of 3 in the lung disease group had undetectable virus levels. At 12 weeks post-treatment, all 10 people in the heart failure group and all 3 remaining participants in the lung disease group had undetectable virus levels. The reported data also shows that 0 participants in either group stopped treatment due to unwanted side effects or serious medical events. It is worth noting that the primary outcome result (very few people recorded as completing the full 24-week course) appears inconsistent with the other data showing high numbers with undetectable virus after treatment — this may reflect how the measure was recorded or defined, but the data as submitted has not been explained 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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NCT00504348 · results posted 24 March 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people in a single group called the "Prospective Investigation Group." Of those, 17 completed the study and 8 did not finish. The trial was looking at two things: how many participants were still alive over the course of the study (called "overall survival"), and how many participants did not experience their condition getting worse over that time (called "progression-free survival"). Progression was defined as meeting specific criteria around lung function measurements, lung imaging results, and the ruling out of certain infections. The reported data shows that 88% of participants were recorded as alive at the point overall survival was measured. For progression-free survival — meaning the proportion of participants who had not died and had not met the criteria for their condition worsening — the reported figure was 76.4%. It is worth noting that 8 out of the 25 participants did not complete the study, which the data does not fully explain, and no comparison group (such as a placebo or standard treatment group) was included in this trial, so these numbers reflect only the single group studied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02888080 · results posted 16 March 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02888080) enrolled 40 people with sarcoidosis — a condition where clusters of inflammatory cells form in the body's organs, particularly the lungs. Twenty participants received the study drug ACZ885 (also known as canakinumab), and 20 received a placebo (an inactive treatment). By the end of the study, 18 people in the ACZ885 group and 15 in the placebo group had completed the trial. The trial was primarily measuring changes in lung function over 24 weeks, using a standard breathing test called spirometry, and also looked at inflammation and lung tissue changes using specialised scans. The reported data shows that for the main outcome — change in lung function measured as "Forced Vital Capacity" (essentially how much air a person can breathe out) — the ACZ885 group showed a change of −1.90 percentage points from their starting level, while the placebo group showed a change of +0.52 percentage points. For the secondary outcomes measuring inflammation in lung tissue using a type of scan (PET/CT) at 12 weeks, the ACZ885 group showed an average change of −4.48% compared to +4.07% in the placebo group. In areas of the lungs with nodules (small lumps), the reported changes were −7.70% for ACZ885 versus +1.03% for placebo, and in regions outside the chest, −21.4% versus +1.76%. Other breathing test measurements and detailed lung scan scoring results were also reported, with small numerical differences between the two groups across various measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03099187 · results posted 3 January 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 253 people in total — 127 received pirfenidone and 126 received a placebo (a dummy treatment) during a 24-week double-blind period, meaning neither the participants nor the researchers knew who was getting which treatment. After that phase, participants moved into a 12-month open-label follow-up where everyone received pirfenidone. The trial was measuring changes in lung function, specifically a breathing test called Forced Vital Capacity (FVC) — essentially how much air a person can breathe out forcefully — to compare the two groups over time. The reported data shows that for the primary outcome — the rate of change in FVC measured by a daily handheld breathing device over 24 weeks — the pirfenidone group recorded figures of −17.9 mL and −90.3 mL (two separate analyses were run due to a review of the home breathing data), while the placebo group recorded 116.6 mL and 125.6 mL respectively. For the secondary outcomes, the reported data shows that 47 people in the pirfenidone group and 74 in the placebo group experienced a drop in FVC of more than 5%, and 18 versus 34 participants experienced a drop of more than 10%. Measurements of another lung function test (DLco, which looks at how well the lungs transfer gas into the bloodstream) showed starting values of around 46% for the pirfenidone group and 50% for the placebo group, with small changes over the study period reported for both groups across multiple analyses. The reported data also shows FVC values in litres and as a percentage of what would be expected for a healthy person of similar age and characteristics, with both groups starting at broadly similar levels (around 2.36–2.38 litres; roughly 74% of predicted) and showing small differences by the end of the study period. Where multiple sets of numbers appear for the same outcome, this reflects repeated analyses the sponsor conducted after additional data review — the data as submitted does not always clearly label which numbers correspond to which time point or analysis, so those figures are described here as reported without further interpretation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02597933 · results posted 13 December 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02597933) enrolled 290 people in the placebo group and 290 people in the nintedanib group — 580 participants in total. The trial ran for 52 weeks and was primarily measuring how quickly lung function declined over that period, specifically looking at a breathing test called Forced Vital Capacity (FVC), which measures the total amount of air a person can breathe out. The trial also measured changes in skin thickness (using a scoring system called the modified Rodnan Skin Score) and changes in respiratory quality of life (using a questionnaire called the Saint George's Respiratory Questionnaire). The reported data shows that for the primary outcome — the annual rate of decline in lung capacity — the placebo group declined by an adjusted average of 93.3 mL per year, while the nintedanib group declined by an adjusted average of 52.4 mL per year. For secondary outcomes, the reported data shows that skin thickness scores (where a higher number means worse thickening) changed by an adjusted average of −1.96 points in the placebo group and −2.17 points in the nintedanib group, out of a possible scale of 0–51. The relative change in skin thickness score was reported as approximately −3.92% for placebo and −10.20% for nintedanib. For the respiratory quality-of-life questionnaire (scored 0–100, where higher is worse), the adjusted average change was −0.88 points in the placebo group and +0.81 points in the nintedanib group. Additional reported data shows the annual rate of FVC decline expressed as a percentage of predicted lung capacity was −2.6% per year for placebo and −1.4% per year for nintedanib, and the absolute change in FVC at 52 weeks was −101.03 mL for placebo and −54.63 mL for nintedanib. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01559129 · results posted 18 October 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01559129) enrolled 23 people with systemic sclerosis (a connective tissue disease also known as scleroderma) — 12 assigned to placebo and 11 assigned to pomalidomide. The trial was measuring several things: unwanted medical events (called adverse events) that occurred during treatment, changes in lung function (specifically a breathing test called forced vital capacity, or FVC, which measures how much air a person can forcibly breathe out), changes in skin thickening (using a 51-point scoring tool called the modified Rodnan skin score), and changes in gut-related quality of life (using a questionnaire called the UCLA SCTC GIT 2.0). After the main treatment phase, a smaller open-label extension period began, in which 6 placebo participants and 2 pomalidomide participants continued — though none completed this extension phase. The reported data shows that during the treatment phase, unwanted medical events were recorded in all 12 placebo participants and 9 of the 10 pomalidomide participants who received treatment. Serious adverse events were reported in 1 placebo participant and 4 pomalidomide participants during the treatment phase. For lung function at week 52, the placebo group's FVC score changed by an average of −2.8 percentage points from their starting level, while the pomalidomide group's changed by −5.2 percentage points (both representing a decline). For skin thickening, the placebo group's score decreased by an average of 3.7 points and the pomalidomide group's by 2.7 points (lower scores indicate less thickening). For the gut symptom questionnaire, the placebo group showed no average change (0.00) and the pomalidomide group showed an average increase of 0.1 points (where higher scores indicate more severe symptoms). The reported data shows that secondary measures — tracking lung function and skin scores at multiple time points throughout the trial — showed varying changes in both groups across the different weeks measured. No data appeared to be missing from these outcome measures as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02803580 · results posted 13 September 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 209 people who had been diagnosed with idiopathic pulmonary fibrosis (IPF) — a condition that causes scarring of the lungs. Of those, 173 completed the study and 36 did not. The trial tracked participants over 12 months, measuring things like the symptoms they were experiencing and how well their lungs were functioning at regular check-ins (at the start, and then at 3, 6, 9, and 12 months). The reported data shows that at the start of the study, 88% of participants reported having IPF symptoms such as cough, fatigue, dizziness, or chest pain. By the 3-month mark that figure had dropped to around 52%, and it continued to sit roughly in the 43–46% range through to the 12-month visit. For lung function, the trial measured several different readings. One measure — vital capacity (the amount of air a person can breathe out after a full breath in) — showed small positive changes from the starting point at each check-in, ranging from +0.03 to +0.08 litres. Another key measure, forced vital capacity (FVC, a similar breath-out test done with force), showed very small negative changes over time, ranging from −0.02 to −0.05 litres, while the percentage of the "predicted normal" FVC showed small positive changes at most visits. Two other lung measures — the volume breathed out in the first second (FEV1) and total lung capacity — also showed small changes, mostly slightly negative, across the follow-up period. The reported data does not include a comparison group, so these numbers reflect the single group of IPF participants 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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NCT02788474 · results posted 6 August 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02788474) enrolled 347 participants across two groups. One group of 231 people received a placebo first, then switched to the drug nintedanib (called "Placebo/Nintedanib"), while a second group of 116 people received nintedanib throughout ("Nintedanib/Nintedanib"). The trial was measuring changes in certain proteins found in the blood — specifically proteins linked to inflammation and tissue breakdown — to see how their levels shifted over time, and also whether participants' lung function declined or they died over the course of the study. The reported data shows that for the primary measure — the rate of change in a blood protein called CRPM (a marker of inflammation-related tissue activity) over 12 weeks — the Placebo/Nintedanib group had an adjusted rate of change of approximately −0.0019 nanograms per millilitre per month, while the Nintedanib/Nintedanib group had a rate of approximately −0.0026 nanograms per millilitre per month. For the key secondary measure, the reported data shows that around 30.4% of participants in the Placebo/Nintedanib group experienced a significant lung function decline (a drop of 10% or more in a breathing test called FVC) or died by week 52, compared with 25.0% in the Nintedanib/Nintedanib group. Two other blood proteins related to tissue breakdown (C1M and C3M) were also measured, with small differences in their rates of change between the two groups reported over 12 weeks, though no further detail beyond those numerical values was provided 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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NCT02745145 · results posted 18 June 2019

According to the results reported on ClinicalTrials.gov, this trial tested a medicine called abituzumab (at two different doses — 500 mg and 1500 mg) compared to a placebo (an inactive treatment) in people with a condition affecting the lungs and skin. A total of 24 people took part: 10 received the placebo, 5 received the 500 mg dose, and 9 received the 1500 mg dose. The trial ran for 52 weeks and measured things like lung capacity, breathlessness, quality of life, skin thickness, and lung scarring. Notably, none of the participants were recorded as having formally "completed" the study — all were listed as "not completed," though the data does not explain why in detail. The reported data shows the following numbers at 52 weeks. For the main measure — lung capacity (the maximum amount of air a person can breathe out) — the placebo group showed a change of −130 millilitres from their starting point, while the 1500 mg abituzumab group showed a change of −50 millilitres. Results for the 500 mg group were not reported for this measure. For breathlessness (scored on a scale where higher is better), the placebo group scored 3 and the 1500 mg group scored 4. For quality of life (scored 0–100, where lower is better), the placebo group changed by +6.4 points and the 1500 mg group by +1.4 points. For lung scarring (0–100, where higher means more scarring), the placebo group changed by +6.29 and the 1500 mg group by −2.27. For skin thickness, only the placebo group's result (a change of 0) was reported; the abituzumab groups' figures were not reported. Regarding survival, 1 person in the 500 mg group died during the study; no deaths were recorded in the placebo or 1500 mg groups. It is worth noting that because of the very small number of participants — particularly only 5 in the 500 mg group — the reported data is limited, and some results for that group were not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01170065 · results posted 6 June 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01170065) enrolled 198 people with idiopathic pulmonary fibrosis (IPF) — a condition that causes scarring of the lungs. Participants were divided into three groups: 37 received a placebo (a dummy treatment with no active ingredient), 126 received a lower dose of nintedanib (50–100 mg), and 35 received a higher dose of nintedanib (150 mg). The trial's main focus was on measuring how quickly lung capacity declined over time, specifically looking at "forced vital capacity" (FVC) — the total amount of air a person can breathe out in one go. A number of other measurements were also tracked, including survival, disease progression, and the rate of sudden worsening episodes (called "acute exacerbations"). The reported data shows that for the primary measurement — the annual rate of decline in FVC — all three groups showed a decrease over the course of the trial. The placebo group declined by an average of 129 millilitres per year, the lower-dose nintedanib group by 137.5 millilitres per year, and the higher-dose group by 132.9 millilitres per year. For the secondary measurements, overall survival rates (measured as the percentage of participants still alive while on treatment) were reported as 37.4% for placebo, 46.8% for the lower-dose group, and 66.2% for the higher-dose group. The percentage of participants who experienced at least one sudden worsening episode was 13.5% (placebo), 19.8% (lower dose), and 20.0% (higher dose). The reported data also shows that the rate at which a separate lung function measure (DLCO — how well the lungs transfer gas into the blood) declined was -0.4, -0.3, and -0.2 units per year for the placebo, lower-dose, and higher-dose groups respectively. It is worth noting that a large proportion of participants across all groups did not complete the trial — 28 of 37 in the placebo group, 92 of 126 in the lower-dose group, and 26 of 35 in the higher-dose group. The reasons for this were not detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01766817 · results posted 22 May 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01766817) enrolled 143 people across three groups: 48 received BMS-986020 at a lower dose (600 mg once daily), 48 received a higher dose (600 mg twice daily), and 47 received a placebo (a dummy treatment with no active ingredient). By the end of the study, 37, 37, and 34 participants in each group respectively had completed the trial. The main thing the trial was measuring was how much a person's lung capacity — specifically a breathing test called Forced Vital Capacity (FVC), which measures how much air someone can breathe out forcefully — changed over 26 weeks. The reported data shows that for the primary measure (FVC rate of change to week 26), all three groups showed a decline in lung capacity. The once-daily dose group declined by an average of 0.076 litres, the twice-daily dose group declined by 0.050 litres, and the placebo group declined by 0.136 litres. For the secondary measures: a lung scarring score (where a smaller increase is considered more favourable) showed ratios of 1.14, 1.09, and 1.11 for the once-daily, twice-daily, and placebo groups respectively. In a six-minute walking distance test, the once-daily group averaged a decrease of 14.2 metres, while the twice-daily group averaged an increase of 6.1 metres, and the placebo group averaged an increase of 10.3 metres. A breathlessness questionnaire (scored 0–120, higher meaning worse) showed average changes of +3.8, −1.7, and +3.9 points for each group. Quality-of-life scores on a physical scale showed average changes of −3.4, −1.0, and −2.1, while the mental scale showed changes of +0.1, +1.7, and −1.1 for the three 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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NCT02606877 · results posted 4 March 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02606877) enrolled two groups of participants — 20 people who had not previously taken either study drug (called "treatment naïve") and 17 people who were already taking pirfenidone. The trial was measuring how the body absorbs and processes two medicines — nintedanib and pirfenidone — when taken together compared to when taken alone. Specifically, it tracked how much of each medicine appeared in the bloodstream over time, and what the highest level reached in the blood was. Sixteen people in each group completed the study. The reported data shows the following numbers for the treatment-naïve group looking at nintedanib: when nintedanib was taken together with pirfenidone, the total amount of the medicine measured in the blood over time (a figure called AUC, which reflects overall exposure) was 150.31 ng·h/mL, compared to 169.69 ng·h/mL when nintedanib was taken alone. The peak level of nintedanib in the blood was reported as 23.04 ng/mL when combined with pirfenidone, versus 28.58 ng/mL when taken alone. A secondary measure extended this blood-level calculation further over time and reported 175.04 ng·h/mL for the combination versus 195.59 ng·h/mL for nintedanib alone. For the pirfenidone-treated group, the reported data shows the total blood exposure to pirfenidone was 39,040.84 ng·h/mL when combined with nintedanib, compared to 40,178.46 ng·h/mL for pirfenidone alone. The peak pirfenidone blood level was 10,537.26 ng/mL with the combination versus 10,591.08 ng/mL for pirfenidone alone. No other outcome figures beyond these were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02802345 · results posted 11 January 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02802345) enrolled 274 participants in total — 136 in a group receiving nintedanib plus a placebo (a dummy pill), and 138 in a group receiving nintedanib plus sildenafil. The trial was measuring changes in quality of life and breathlessness in people with a lung condition, using two questionnaires: the St George's Respiratory Questionnaire (SGRQ), which scores how much a lung condition limits a person's life (0–100, where higher means more limitations), and the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ), which scores breathlessness during activities. Around 104–108 participants in each group completed the full study. The reported data shows that at 12 weeks, the main (primary) measure — the SGRQ total score — changed by an average of −0.77 points in the nintedanib-plus-placebo group and −1.28 points in the nintedanib-plus-sildenafil group. Both of these changes are smaller than the 4-point difference that the researchers had set as the threshold for a clinically meaningful change. For breathlessness at 12 weeks, scores increased by an average of 4.40 points in the placebo group and 1.46 points in the sildenafil group (a higher score means more breathlessness). At 24 weeks, the reported SGRQ scores had increased (worsened) by an average of 2.42 points in the placebo group and 0.23 points in the sildenafil group, while breathlessness scores increased by 6.85 and 4.44 points respectively. The reported data also shows that serious unwanted medical events during the study occurred in 32.4% of participants in the nintedanib-plus-placebo group and 27.0% in the nintedanib-plus-sildenafil 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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NCT01872689 · results posted 24 August 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called lebrikizumab in people with a lung condition called idiopathic pulmonary fibrosis (IPF), a disease where lung tissue becomes scarred over time. The trial had two groups: one where participants received lebrikizumab or a dummy treatment (placebo) on their own ("monotherapy"), and another where participants received lebrikizumab or placebo on top of an existing treatment called pirfenidone ("combination therapy"). In total, 505 people took part in the main controlled phase — 76 on placebo alone, 78 on lebrikizumab alone, 177 on placebo plus pirfenidone, and 174 on lebrikizumab plus pirfenidone. The main thing being measured was how much a standard breathing test result — called forced vital capacity (FVC), which measures how much air a person can breathe out forcefully — changed over 52 weeks. The reported data shows that across all four groups, FVC declined over the year. In the monotherapy group, the placebo group's FVC declined at a rate of about 6.2 percentage points per year, while the lebrikizumab-alone group's rate was about 5.2 percentage points per year. In the combination therapy group, the placebo-plus-pirfenidone group declined at about 6.0 percentage points per year, and the lebrikizumab-plus-pirfenidone group at about 5.5 percentage points per year. For a secondary measure — how far participants could walk in 6 minutes — the reported data shows the monotherapy placebo group declined by about 44.7 metres per year versus about 22.7 metres per year in the lebrikizumab-alone group; in the combination therapy group, the placebo-plus-pirfenidone group declined by about 25.6 metres per year while the lebrikizumab-plus-pirfenidone group declined by about 47.0 metres per year. The reported data also shows that 34.2% of people in the monotherapy placebo group either had a significant drop in their breathing test result (10% or more) or died, compared with 27.6% in the lebrikizumab-alone group. In the combination therapy groups, those figures were 30.3% for placebo-plus-pirfenidone and 26.6% for lebrikizumab-plus-pirfenidone. A measure of how quickly gas moves across the lungs (called DLco) also declined across all groups over the year, with figures ranging from approximately 4.2 to 5.8 units per year depending on the group; the median time to a significant decline or death could only be estimated for the monotherapy placebo group (about 53 weeks), as the data for the other three groups was not reported in a way that allowed a median to be calculated. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01619085 · results posted 26 July 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01619085) enrolled 752 participants in total, with 751 going on to receive the study treatment. The trial was measuring how often participants experienced adverse events — that is, any unwanted or unexpected medical occurrences that happened during the course of the study. This included tracking serious adverse events, adverse events that caused someone to stop the treatment, and adverse events that resulted in death. It is worth noting that 525 participants did not complete the trial, and only 227 finished it, though the reasons for not completing were not detailed in the data provided. The reported data shows that adverse events were very common among participants. Specifically, 98.5% of participants experienced at least one adverse event of any kind during the trial. The reported figures also show that 42.6% of participants had a serious adverse event, 68.9% had an adverse event that led them to stop taking the treatment, and 23.8% experienced a fatal adverse event (meaning they died during the course of the trial). No secondary outcome measure data was included in the results submitted to ClinicalTrials.gov, so those figures are not available to report here. It is important to understand that these numbers describe what was observed and recorded during the trial — they do not on their own tell us whether the treatment caused these events or how the rates compare to what might have been expected without the treatment, as no comparison group data was provided in this submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01629667 · results posted 15 May 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 176 people in total across three groups: one group received a placebo (an inactive treatment), one received a dose of 400 mg of a medicine called tralokinumab, and one received 800 mg of tralokinumab. The trial was studying people with idiopathic pulmonary fibrosis (IPF), a serious lung condition, and ran for up to 88 weeks. The main thing being measured was how much a standard breathing test result — called forced vital capacity, or FVC, which measures the amount of air a person can forcibly breathe out — changed over 52 weeks. It is worth noting that a relatively large number of participants did not complete the study: only 12 in the placebo group, 17 in the 400 mg group, and 14 in the 800 mg group finished. The reported data shows that at the start of the trial, average FVC results (expressed as a percentage of what would be expected for a healthy person of the same age, sex, and height) were around 70% across all three groups. By week 52, the reported change from that starting point was a decline of about 4.1 percentage points in the placebo group, 6.1 percentage points in the 400 mg tralokinumab group, and 6.1 percentage points in the 800 mg tralokinumab group. For the secondary outcomes, the reported data shows that unwanted medical events during the study (called adverse events) were recorded in 53 of 57 placebo participants, 50 of 57 in the 400 mg group, and 57 of 59 in the 800 mg group. Serious adverse events were recorded in 13, 16, and 17 participants respectively. Regarding disease progression — defined by meaningful declines in breathing tests, hospitalisation, or respiratory-related death — roughly 35% of the placebo group and 35% of the 400 mg group showed progression at one reported time point, compared with about 29% of the 800 mg group, though at a later time point those figures rose to around 42%, 42%, and 44% 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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NCT01769196 · results posted 13 April 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 544 people in total — 272 who received a medicine called simtuzumab, and 272 who received a placebo (an inactive dummy treatment). The trial was looking at a lung condition, and the main thing it was measuring was "progression-free survival" — that is, how long participants went before their lung function (measured by a breathing test called FVC, or forced vital capacity) declined by a meaningful amount. The trial also looked at overall survival (how long participants lived during the study period). Notably, the data shows that none of the 544 participants completed the trial, meaning all participants left or stopped before the study concluded. The reported data shows that for the main measure — progression-free survival across all participants — the simtuzumab group had a reported figure of 12.6 months, compared with 15.4 months in the placebo group. When the analysis was narrowed to participants who had higher baseline levels of a protein called sLOXL2 (at or above the 50th percentile, meaning the upper half of levels measured), the reported figures were 11.7 months for simtuzumab and 14.3 months for placebo. For those with even higher sLOXL2 levels (at or above the 75th percentile, meaning the top quarter), the figures were 11.6 months for simtuzumab and 16.9 months for placebo. For the secondary measure of overall survival — in all three participant groupings — the data was listed as "not available" and was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00080223 · results posted 9 March 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 83 participants, all of whom received the study drug pirfenidone. Only 7 participants completed the study, while 76 did not complete it. The trial was primarily measuring how often participants experienced unwanted medical events (called adverse events) while taking the study drug. It also tracked several measures of lung function and breathing over time, as well as how long participants survived. The reported data shows that the vast majority of participants — 98.8% — experienced at least one adverse event (an unwanted medical occurrence linked to the study drug) during the trial. Of those, 59.0% experienced a serious adverse event (one serious enough to require hospitalisation or posing an immediate risk of dying, among other criteria), 36.1% had a severe adverse event (meaning it markedly limited their activity or required medical treatment), 21.7% experienced a life-threatening adverse event, 25.3% died, and 43.4% stopped taking the study drug because of an adverse event. For the lung function measures, the reported data shows that participants' lung capacity (measured as a percentage of what would be expected for a healthy person of the same age, sex and height) hovered around 65–70% across the various measurement points throughout the study. A separate measure of how well the lungs transfer oxygen into the blood sat at roughly 35–40% of the predicted healthy level across measurement points. Resting blood oxygen levels remained relatively stable across measurements, generally around 94–96%. The reported data also shows that the median survival time from the first dose was approximately 508.7 weeks (roughly 9–10 years), though the way this figure was calculated means it may reflect varying lengths of follow-up among 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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NCT01385644 · results posted 29 December 2015

According to the results reported on ClinicalTrials.gov, this trial involved 8 people in total, split into two groups of 4. One group received a lower dose of a type of cell therapy called MSCs (mesenchymal stem cells) — 1 million cells per kilogram of body weight — and the other group received a higher dose of 2 million cells per kilogram. All 8 participants completed the study. The trial was primarily looking at whether the infusion caused certain immediate, serious reactions — specifically a severe allergic reaction (anaphylaxis) or a significant change in blood pressure or heart rate shortly after the infusion. It also tracked changes in lung function and walking ability over 6 months compared to where participants started (their "baseline"). The reported data shows that, for the primary measure, zero participants in either group experienced those acute reactions following the infusion. For the secondary measures, lung function was assessed in two ways. One lung function test (called FVC, which measures how much air a person can breathe out) was reported as sitting at 99% of baseline in the lower-dose group and 94% of baseline in the higher-dose group at 6 months, meaning both groups were close to where they started. A second lung function test (called DLCO, which measures how well the lungs transfer gas into the blood) was reported at 117% of baseline in the lower-dose group and 86% of baseline in the higher-dose group. For the 6-minute walk test — how far someone can walk in 6 minutes — both groups were reported at 104% of baseline, slightly above where they started. It is worth noting that with only 4 people in each group, this was a very small study, and the reported data reflects a limited number of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01933334 · results posted 28 September 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01933334) looked at two different ways of gradually increasing the dose of a medicine called pirfenidone — one group had their dose increased over 2 weeks, and the other over 4 weeks. A total of 63 people took part (32 in the 2-week group and 31 in the 4-week group). The trial's main focus was on tracking unwanted medical events (called adverse events) that came up after starting the medicine, as well as more serious medical events. A secondary focus was measuring gut-related symptoms using a detailed questionnaire. The reported data shows that nearly all participants in both groups experienced at least one treatment-emergent adverse event — 96.9% in the 2-week group and 96.8% in the 4-week group. For more serious adverse events (those involving hospitalisation, life-threatening situations, lasting disability, or death), the reported figures were 9.4% in the 2-week group and 0% in the 4-week group. For the gut symptom questionnaire, scores were reported across several areas (such as reflux, bloating, diarrhoea, and emotional wellbeing), all measured on a scale where 0 means better and higher numbers mean worse symptoms. The reported total scores were approximately 0.43 for the 2-week group and 0.34 for the 4-week group, with similarly low scores across the individual symptom categories 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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NCT01335477 · results posted 13 February 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01335477) enrolled 551 people with idiopathic pulmonary fibrosis (a condition where the lungs progressively scar over time) — 220 received a placebo (a dummy treatment) and 331 received nintedanib 150 mg twice daily. The trial ran for 52 weeks and was primarily measuring how quickly lung capacity declined, using a breathing test called Forced Vital Capacity (FVC), which measures the total amount of air a person can breathe out in one go. The reported data shows that, over 52 weeks, the placebo group's FVC declined by an adjusted average of about 207 millilitres per year, while the nintedanib group's FVC declined by an adjusted average of about 114 millilitres per year. Looking at the absolute change over the full 52 weeks, the placebo group showed an average decline of around 205 millilitres compared to around 95 millilitres in the nintedanib group. In percentage terms, the placebo group's lung capacity declined by an adjusted average of about 8.1%, compared to about 3.9% in the nintedanib group. For quality of life (measured using a questionnaire scored from 0 to 100, where a higher score means poorer health), the placebo group's score rose by an adjusted average of 5.48 points and the nintedanib group's score rose by 2.80 points. The reported data also shows that 9.6% of people in the placebo group experienced a sudden serious worsening of their condition (called an acute exacerbation) during the 52 weeks, compared to 3.6% in the nintedanib group. Of the 551 people who started the trial, 179 in the placebo group and 272 in the nintedanib group completed it; the data was not reported in a way that explains why the remaining participants did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01335464 · results posted 13 February 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 515 people with idiopathic pulmonary fibrosis (IPF) — a condition that causes progressive scarring of the lungs. Of these, 206 received a placebo (an inactive treatment) and 309 received nintedanib at a dose of 150 mg twice daily. The trial ran for 52 weeks and was primarily measuring how quickly lung capacity declined over that period, using a breathing test called Forced Vital Capacity (FVC) — essentially the total amount of air a person can breathe out in one go. The reported data shows that, on average, the placebo group's FVC declined by approximately 240 mL per year, while the nintedanib group's FVC declined by approximately 115 mL per year. In percentage terms, the placebo group showed an average decline of about 7.4% from their starting lung capacity, compared to about 3.4% in the nintedanib group. For a secondary measure — a quality-of-life questionnaire called the Saint George's Respiratory Questionnaire, scored from 0 (best) to 100 (worst) — both groups showed a similar small increase from their starting scores (about 4.4 points for placebo and 4.3 points for nintedanib), meaning both groups reported a slight worsening in health-related quality of life; the reported figures between the two groups were very close. Regarding sudden worsening episodes (called acute exacerbations), the reported data shows that approximately 5.4% of placebo participants and 6.1% of nintedanib participants experienced at least one such episode over the 52 weeks. It is also worth noting that not everyone completed the trial — 32 people in the placebo group and 49 in the nintedanib group did not finish, 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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NCT00514683 · results posted 6 January 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 432 people across five groups to test different doses of nintedanib (a medicine) compared to a placebo (a dummy treatment with no active ingredient) in people with a lung condition. The five groups were: placebo, nintedanib 50 mg once a day, nintedanib 50 mg twice a day, nintedanib 100 mg twice a day, and nintedanib 150 mg twice a day. Each group started with around 86–87 participants. The trial ran for 52 weeks and was primarily measuring how quickly lung capacity — specifically a breathing measurement called Forced Vital Capacity (FVC), which is essentially how much air a person can breathe out — declined over that year. The reported data shows that across all groups, FVC declined over the 52 weeks, but the amount of decline differed between groups. For the primary measure — the rate of lung capacity decline per year — the placebo group showed a decline of 0.190 litres per year, while the nintedanib groups showed declines of 0.174, 0.210, 0.162, and 0.060 litres per year (for the 50 mg once daily, 50 mg twice daily, 100 mg twice daily, and 150 mg twice daily groups respectively). For the secondary measures looking at the total change in lung capacity at 52 weeks, the placebo group showed a drop of about 0.23 litres on average, compared to drops of 0.18, 0.19, 0.13, and 0.06 litres across the four nintedanib groups. When expressed as a percentage change from the starting point, the placebo group's lung capacity fell by around 7.96% on average, while the nintedanib groups fell by 6.98%, 7.16%, 4.13%, and 2.52% respectively. The reported data also shows that when participants were grouped by how much their lung capacity changed, 37 out of 87 placebo participants had a meaningful decline (greater than 10% or 200 mL), compared to 35, 41, 30, and 20 participants in the four nintedanib groups. Note that some secondary outcome figures were not fully reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01254409 · results posted 3 November 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 21 people in total across four groups: 6 received a placebo (an inactive substance), 6 received a low dose of PRM-151 (1 mg/kg), 5 received a medium dose (5 mg/kg), and 4 received a high dose (10 mg/kg). The trial was primarily measuring safety and tolerability — that is, whether participants experienced serious unwanted reactions or other side effects at different doses of PRM-151. It also measured how the drug moved through the body over time (sometimes called pharmacokinetics). The reported data shows that, for the primary measure, zero participants in any group experienced what the trial defined as a "dose-limiting toxicity" (a side effect serious enough to limit the dose) or a serious adverse event (a significant unwanted medical event). All participants across all groups — including the placebo group — were recorded as having experienced at least one adverse event of any kind, though the data does not break down what those events were. For the secondary measures, the reported data shows that as the dose increased, the peak concentration of PRM-151 measured in the blood rose from 25.5 µg/mL at the lowest dose to 145 µg/mL at the middle dose and 225 µg/mL at the highest dose. The time it took to reach that peak was shorter at higher doses (about 5.4 hours at the lowest dose, down to under 1 hour at the highest). The reported data also shows that the drug appeared to stay in the body longer at higher doses, with the estimated "half-life" (the time for the amount in the body to reduce by half) ranging from about 22 hours at the lowest dose to about 72 hours at the highest 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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NCT00768300 · results posted 8 April 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT00768300) enrolled 330 people in the ambrisentan group and 164 people in the placebo group — a total of 494 participants — all of whom had idiopathic pulmonary fibrosis (IPF), a condition where lung tissue becomes scarred over time. The trial was measuring how long it took for participants to either die or experience a significant worsening of their condition, as well as a number of other measures of lung function, physical ability, and quality of life, tracked over 48 weeks. The reported data shows that for the primary measure — time to death or disease worsening — the median time for the ambrisentan group was approximately 84 weeks, while a median figure for the placebo group was not reported in the submitted data. For the secondary measures at 48 weeks, the reported data shows that 65% of participants in the ambrisentan group had not experienced disease worsening or death, compared with 80% in the placebo group. Lung function measured by the volume of air forcibly breathed out (FVC) declined by around 10% in the ambrisentan group and around 5% in the placebo group. A separate lung efficiency measure (how well oxygen passes into the blood, called DLCO) declined by about 3% in the ambrisentan group and about 11% in the placebo group. The distance participants could walk in six minutes decreased by roughly 53 metres in the ambrisentan group and about 11 metres in the placebo group. Quality of life scores, rated on a scale of 0–100, declined slightly in both groups across the measures 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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NCT00903331 · results posted 17 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 178 people in total — 59 received a placebo (a dummy treatment with no active ingredient) and 119 received the study drug, ACT-064922. The trial was looking at a lung condition called idiopathic pulmonary fibrosis (IPF), a disease where the lungs gradually stiffen and scar. The main thing being measured was lung capacity, specifically a breathing test called Forced Vital Capacity (FVC), which records how much air a person can breathe out in one go. By the end of the study, 54 people in the placebo group and 101 in the ACT-064922 group had completed the trial. The reported data shows that at the start of the study (baseline), the average FVC was 2.74 litres in the placebo group and 2.83 litres in the ACT-064922 group. At the end of the first period of the trial, the reported average FVC was 2.40 litres in the placebo group and 2.57 litres in the ACT-064922 group. As a secondary outcome, the trial also tracked how many participants were at risk of their disease getting worse or of dying over time. The reported data shows the numbers of participants remaining at risk at various points during the study, starting at 59 (placebo) and 112 (ACT-064922), and reducing over time down to 2 (placebo) and 1 (ACT-064922) by the final time point recorded. It is worth noting that some data points in the secondary outcome (such as the exact time intervals between the recorded numbers) were not fully detailed 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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NCT00587158 · results posted 8 May 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 100 kidney transplant recipients — 49 in a control group receiving standard immunosuppression (anti-rejection medication) alone, and 51 in a group receiving standard immunosuppression plus a medication called paricalcitol. The trial was measuring whether adding paricalcitol made a difference to parathyroid hormone (PTH) levels — a blood marker related to the parathyroid gland, which helps control calcium and bone health — as well as bone density in the hip and lower spine, one year after transplant. Around 87 participants completed the full study. The reported data shows that, at the one-year mark, 31 out of the control group participants had elevated PTH levels (a condition called hyperparathyroidism), compared with 15 out of the paricalcitol group. For bone density in the hip, 9 participants in the control group and 12 in the paricalcitol group had lower-than-normal readings. For the lower spine, those numbers were 9 and 14 respectively. The reported data also shows PTH blood levels measured in both groups at several points over the year — starting similarly high in both groups (236 and 198 units respectively before transplant), then falling and remaining lower in the paricalcitol group at later time points (for example, 42 versus 85 units at the final measurement). The change in lower spine bone density score over the year was reported as the same in both groups (0.35 T-score units). The reported data also includes a bone turnover marker (bone alkaline phosphatase), which appeared to follow a broadly similar pattern in both groups across the year, though some individual time-point readings differed. No data on certain other outcomes appeared to be reported in the submission, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00105183 · results posted 8 June 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 223 people in total across three groups: 82 received a higher dose of the experimental treatment EZ-2053 (9 mg/kg), 62 received a lower dose of EZ-2053 (5 mg/kg), and 79 received a placebo (an inactive treatment used for comparison). The trial appears to have been conducted in the context of organ transplantation, and it was measuring outcomes such as death, graft loss (where a transplanted organ stops working), acute rejection (where the body attacks the transplanted organ), and loss to follow-up (participants who could not be tracked). Not all participants completed the study — 60 finished in the higher-dose group, 39 in the lower-dose group, and 60 in the placebo group. The reported data shows that for the primary (main) outcome — tracking how many participants experienced death, graft loss, acute rejection, or loss to follow-up — 33 people in the higher-dose group, 30 in the lower-dose group, and 29 in the placebo group recorded one of these events. For the secondary (additional) outcomes, the reported data shows that death or graft loss occurred in 13, 7, and 8 participants in the higher-dose, lower-dose, and placebo groups respectively. Acute rejection was recorded in 22, 22, and 20 participants across those same groups. Infections were recorded in 75, 57, and 70 participants respectively. Serious adverse events (significant unwanted medical occurrences) were reported in 18, 9, and 14 participants. A six-minute walk test — where participants walked as far as they could in six minutes — recorded average distances of 457 metres, 427 metres, and 448 metres across the higher-dose, lower-dose, and placebo groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01442779 · results posted 29 September 2011

According to the results reported on ClinicalTrials.gov, this trial (NCT01442779) involved 18 people who all received a treatment called Interferon Alpha. The trial was looking at two main things after one year: whether participants' lung disease (measured using a detailed type of CT scan and breathing tests) stayed stable or showed minimal worsening, and whether their quality of life stayed the same or showed minimal change. A secondary, shorter-term measurement looked at whether coughing changed after one month of treatment. The reported data shows that out of the 18 people who started the trial, 11 completed it and 7 did not finish. For both of the main (primary) outcome measures — lung disease progression and quality of life — the reported number was 12 participants showing minimal or no progression, and 12 participants showing minimal or no change in quality of life. It is worth noting that more people were counted in these outcome results (12) than actually completed the trial (11), and the submitted data does not explain this difference. For the secondary measure around coughing, the reported data shows that 5 participants had a change in their cough after one month of treatment. It is important to understand that this was a small trial with only one group, meaning there was no comparison group of people who did not receive the treatment. This makes it difficult to draw broader conclusions from the numbers 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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NCT00287729 · results posted 13 June 2011

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called pirfenidone (taken at a daily dose of 2,403 mg) compared to a placebo (a dummy treatment with no active ingredient) in people with a lung condition. A total of 171 people were assigned to pirfenidone and 173 to placebo, making 344 participants in all. The trial ran for 72 weeks (roughly a year and a half) and mainly measured changes in lung function — specifically something called "percent predicted forced vital capacity" (FVC), which is a way of scoring how much air a person can breathe out forcefully compared to what would be expected for someone their age and size. A lower score over time means lung function has declined. The reported data shows that, on average, the pirfenidone group's FVC score fell by 9 percentage points from the start of the trial to week 72, while the placebo group's score fell by 10 percentage points. For the six-minute walk test — where participants walked as far as they could in six minutes — the pirfenidone group's distance dropped by an average of 45 metres, compared to a drop of 77 metres in the placebo group. When it came to a lung gas-transfer test (DLco, a measure of how well the lungs pass oxygen into the blood), both groups showed a decline of roughly 9–10 percentage points. In terms of disease progression (defined as a significant drop in lung function or death), 54 people in the pirfenidone group and 60 in the placebo group were recorded as having progressed. Oxygen saturation levels during the walk test showed a small decline in both groups (about 1–2 percentage points each). The reported data also shows how participants were grouped by how much their FVC changed: in the pirfenidone group, 88 people had a severe decline (20% or more, including those who died or had a lung transplant), compared with 89 in the placebo group; 41 pirfenidone participants showed a mild improvement versus 33 in the placebo group; and 19 pirfenidone participants had a moderate decline compared with 23 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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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.