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 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.
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 recognised international guidelines
- Your lung scans (and lung tissue sample results, if you have had one) have been reviewed and are consistent with an IPF diagnosis
- Your lung gas exchange ability (a breathing test measuring how well oxygen moves into your blood) is between 30% and 79% of what is considered normal
- Your lung capacity (measured by a breathing test called FVC) is at least 50% of what is considered normal
Who may not be able to join:
- Your liver enzyme levels (AST or ALT) are more than 1.5 times the upper limit of normal on a blood test
- Your bilirubin level (a marker of liver function) is more than 1.5 times the upper limit of normal
- You have a significant airway blockage, based on breathing test results
- You are expected to need a lung transplant during the study period (note: being on a transplant waiting list alone does not automatically exclude you)
- You have had a heart attack in the past 6 months
- You have had unstable chest pain (angina) in the past month
- You have a condition or history that increases your risk of bleeding, including certain blood-thinning medications, a brain bleed in the past 12 months, or major surgery or injury in the past 3 months (confirm with trial site)
- You have a condition or history that increases your risk of blood clots, including a stroke or similar event in the past 12 months (confirm with trial site)
- Your blood clotting test results are significantly outside the normal range (confirm with trial site)
- You have taken N-Acetyl Cysteine or steroid medication (prednisone above 15mg/day or similar) within the past 2 weeks
- You have taken certain other medications including pirfenidone, azathioprine, cyclophosphamide, or cyclosporine A within the past 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.
Contact this trial
Principal Investigator: Boehringer Ingelheim, Boehringer Ingelheim
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
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: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.