Trial 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
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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 33902584) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Interstitial Lung Disease Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You are 40 years of age or older
- You have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) — a type of lung scarring disease — within the last 5 years, following the most up-to-date international guidelines
- Your lung scans (and lung biopsy results, if you have had one) have been reviewed and confirm your IPF diagnosis
- Your lung's ability to transfer oxygen into the blood (a breathing test result called DLCO) is between 30% and 79% of what is considered normal
- Another breathing test result (called FVC) shows your lungs are working at 50% or more of what is considered normal
Who may not be able to join:
- Your liver enzyme levels (AST or ALT) are significantly above the normal range, based on a blood test
- Your bilirubin level (a substance measured in blood that reflects liver health) is significantly above the normal range
- You have a significant blockage or obstruction in your airways, shown by a specific breathing test result (confirm with trial site)
- You are expected to need a lung transplant during the study period (being on the waiting list is still acceptable)
- You have had a heart attack in the last 6 months
- You have had unstable chest pain (angina) in the last month
- You have a condition or history that increases your risk of bleeding, including certain medications, a brain bleed within the past year, coughing up blood, blood in urine, active stomach bleeding, ulcers, or major surgery within the last 3 months
- You have a condition or history that increases your risk of blood clots, including a stroke or similar event within the past 12 months
- Certain blood clotting test results are significantly outside the normal range (confirm with trial site)
- You have taken N-Acetyl Cysteine or more than 15mg/day of prednisone (or a similar steroid) within the last 2 weeks
- You have taken certain immune-suppressing or anti-scarring medicines (including pirfenidone, azathioprine, cyclophosphamide, or cyclosporine A) within the last 8 weeks
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.