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 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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 35783648) ↗
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 2 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 between 18 and 85 years old
- You have been diagnosed with a scarring lung disease (fibrosing ILD) that specialists, after a team review, could not confidently identify as a specific known type of lung disease
- Your lung disease has been getting worse in the past 6 months, shown either by a measurable drop in lung capacity or by clearly worsening symptoms not caused by heart or blood vessel problems
- A special lung scan (high-resolution CT) shows that more than 10% of your lungs are affected by scarring
- Your lungs are still working at 45% or more of the expected level for someone your age and size (based on a breathing test called FVC)
- A test measuring how well your lungs transfer oxygen into your blood (DLco) shows at least 30% of the expected level
- A specific breathing test ratio (FEV1/FVC) is 0.7 or above, meaning your airways are not significantly blocked
- You are able to walk at least 150 metres in a 6-minute walk test
- If you are a woman who could become pregnant, you agree to use reliable contraception (hormonal or non-hormonal with less than 1% failure rate per year, or to remain abstinent) during the treatment and for at least 90 days after your last dose of the study drug
- If you are a man, you agree to use contraception or remain abstinent, and to not donate sperm during the trial
Who may not be able to join:
- You have been diagnosed with a specific identifiable type of scarring lung disease, such as one caused by a connective tissue condition, chronic allergic lung inflammation, or other known causes
- You have been diagnosed with idiopathic pulmonary fibrosis (IPF), regardless of how certain that diagnosis is
- You have had unstable chest pain (angina) or a heart attack in the past 6 months
- You have taken high-dose steroid tablets or certain immune-suppressing medicines (other than a specific drug called mycophenolate mofetil/acid) in the 4 weeks before screening
- You have previously been treated with pirfenidone (the study drug) or nintedanib
- You have taken a supplement called N-acetyl-cysteine for your lung disease in the 4 weeks before screening
- You are currently taking any medication to treat pulmonary hypertension (high blood pressure in the lungs)
- You have taken part in another clinical drug trial in the past 4 weeks
- You have significant problems with another major organ, including your liver or kidneys
- Your expected life expectancy is less than 12 months, or you are already on an active waiting list for a lung transplant
- You have used any tobacco products in the 12 weeks before screening, or are unwilling to stop using them throughout the trial
- You have had issues with alcohol or drug misuse in the past 12 months
- You are planning to have major surgery during the trial
- You have a known allergy or sensitivity to pirfenidone or any of its ingredients
- You have a history of a serious allergic reaction causing swelling (angioedema)
- You are currently taking a medication called fluvoxamine (often used for depression or OCD)
- You have signs of any active infection at the time of screening
- You have a history of liver problems, or your liver blood test results are above certain limits (confirm with trial site for specific values)
- Your kidneys are not filtering well enough, based on a specific calculation using a blood test result (confirm with trial site)
- You have any serious medical condition, or abnormal results on a heart tracing (ECG) or blood tests at the time of screening
- Your ECG shows a specific heart rhythm measurement (QTc interval) of 500 milliseconds or more, or you have a personal or family history of a heart condition called long QT syndrome
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: Clinical Trials, Hoffmann-La Roche
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
8 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Rate of Decline in Forced Vital Capacity (FVC) Over the 24-week Double-blind Treatment Period
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.