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 (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.
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 4 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 willing and able to sign a consent form agreeing to take part before any study activities begin
- You are male or female and aged 40 years or older
- You have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) — a type of lung scarring disease — within the last 3 years, based on recognized medical guidelines
- You have had a detailed chest CT scan (a type of X-ray imaging) within the last 18 months
- Your CT scan results, and lung tissue biopsy results if you had one, match the expected pattern for IPF, as confirmed by a central review team
- Your lungs are able to hold at least 80% of the air that would be expected for a healthy person of your age and size (confirmed by a breathing test)
Who may not be able to join:
- Your liver function blood test results are significantly above the normal range at your first visit
- Your bilirubin level (a measure of liver health) is significantly above the normal range at your first visit
- You have an existing long-term liver disease
- You have significant airway blockage, shown by a specific breathing test result (confirm with trial site)
- You have had a heart attack in the last 6 months, or unstable chest pain in the last month
- You have a known tendency to bleed easily due to a genetic condition
- You need certain blood-thinning or clot-dissolving treatments
- You have had a bleed in your brain or nervous system within the last 12 months
- You have had coughing up blood, blood in your urine, active stomach or gut bleeding, stomach ulcers, or a major injury or surgery within the last 3 months
- Your blood clotting test results are above a safe level at your first visit
- You are planning to have major surgery during the trial, including a lung transplant or major stomach or bowel surgery
- You have had a blood clot, stroke, or mini-stroke within the last 12 months
- Your kidneys are not working well enough, based on a specific calculation using a blood test (confirm with trial site)
- You are currently taking or have recently taken certain medications, including nintedanib, pirfenidone, azathioprine, cyclosporine, high-dose steroids, or other experimental drugs within 4 weeks of a specific study visit
- You are known to be allergic to nintedanib, peanuts, soya, or any ingredient in the study medicine
- You have previously had to stop taking nintedanib because of side effects
- You have another illness or condition that the trial doctor feels could interfere with the study or put you at risk
- You have a problem with alcohol or drug use that could affect your ability to take part safely
- You are not able to understand or follow study instructions, such as doing breathing tests at home or completing questionnaires on your own
- You are pregnant, breastfeeding, planning to become pregnant during the trial, or have a positive pregnancy test at the start of the trial
- You are a woman who could become pregnant and are not willing or able to use a highly effective form of contraception throughout the trial
- You have had a sudden worsening of your IPF or any respiratory (breathing) tract infection in the 4 weeks before your first visit or during the screening period
- You are currently taking part in, or have taken part in, another clinical trial with an experimental drug within one month before your first visit, or you have previously been enrolled in this same trial
- There may be additional reasons you cannot join that are not listed here (confirm with trial site)
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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
The Rate of Change (Slope) in Blood C-reactive Protein Degraded by Matrix Metalloproteinase-1/8 (CRPM) From Baseline to Week 12.
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.