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Study on Idiopathic Pulmonary Fibrosis: Evaluating Pirfenidone and Nintedanib for Patients with Progressive Disease

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a lung disease called idiopathic pulmonary fibrosis (IPF). IPF is a condition where the lungs become scarred and breathing becomes difficult over time. The study will explore the effectiveness of two medications, pirfenidone and nintedanib, which are already used to treat IPF. Nintedanib is also known by its code name, BIBF 1120. The trial will compare different treatment approaches: using both medications together, switching from one to the other, or continuing with just one of them.

The purpose of the study is to evaluate how these treatments affect the decline in lung function over a period of 24 weeks. Participants will take the medications in the form of capsules or tablets, and their lung function will be measured at the start of the study and then again at weeks 4, 12, and 24. This will help determine how well the treatments are working in slowing down the progression of the disease.

Throughout the study, the tolerance of the medications will also be monitored, which means checking how well participants can handle the treatment without significant side effects. The study will also look at other factors, such as the time it takes for participants to stop the medication permanently, any hospitalizations related to lung issues, and overall survival without hospital admissions. The goal is to find the most effective way to manage IPF and improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This assignment determines the specific treatment plan to be followed during the trial.

  2. Step 2

    Baseline assessment

    A baseline assessment will be conducted to measure the forced vital capacity (FVC) using hospital spirometry. This assessment provides a starting point for evaluating changes over the course of the study.

  3. Step 3

    Treatment administration

    The patient will receive one of the following treatments: Ofev 150 mg soft capsules (nintedanib) or Esbriet 267 mg film-coated tablets (pirfenidone).

    The medication will be taken orally, with the dosage and frequency determined by the assigned treatment group. The patient must adhere to the prescribed regimen for the duration of the study.

  4. Step 4

    Follow-up assessments

    Follow-up assessments will occur at week 4, week 12, and week 24. These assessments will involve measuring the FVC to monitor changes in lung function.

    The assessments will help evaluate the effectiveness of the treatment in managing the progression of idiopathic pulmonary fibrosis.

  5. Step 5

    Monitoring and reporting

    Throughout the study, the patient will be monitored for any side effects or changes in health status. It is important to report any new symptoms or concerns to the study team promptly.

    The patient will also be asked to complete questionnaires about symptoms and quality of life at various points during the study.

  6. Step 6

    End of study

    At the end of the 24-week study period, a final assessment will be conducted to evaluate the overall impact of the treatment on lung function and quality of life.

    The results will contribute to understanding the effectiveness of the treatment strategies for idiopathic pulmonary fibrosis.

Who can join the trial?

12 criteria

  • Patient aged 50 years or older.
  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) according to specific medical guidelines. This involves using special imaging tests and tissue samples to confirm the condition.
  • Patient must show signs of IPF getting worse in the past 12 months, even with treatment. This can be shown by:
    • A decrease in lung function by 10% or more.
    • A decrease in lung function by 5% to less than 10% and worsening breathing symptoms.
    • A decrease in lung function by 5% to less than 10% and more scarring seen on lung images.
    • Worsening breathing symptoms and more scarring seen on lung images.
    • Patient must have been taking a stable dose of either pirfenidone or nintedanib for at least 6 months, with good tolerance. These are medications used to treat IPF.
    • Patient must have a Forced Vital Capacity (FVC) of 45% or more of what is predicted for their age and size. FVC is a measure of lung function.
    • Patient must have a Forced Expiratory Volume in 1 second (FEV1) to FVC ratio of 0.70 or more. This is another measure of lung function.
    • Patient must have a life expectancy of at least 9 months, as judged by the doctor.
    • Patient must have given written consent to participate in the study.
    • Patient must be part of a social insurance program.

Who cannot join the trial?

5 criteria

  • Patients who are not diagnosed with idiopathic pulmonary fibrosis cannot participate. This is a lung disease where the cause is unknown.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who are part of a vulnerable population cannot participate. This usually means groups that need special protection, like children or pregnant women.
  • Patients who are not able to perform the required lung function tests cannot participate. These tests measure how well the lungs are working.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
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Investigated drugs

  • Pirfenidone

    is a medication used to treat idiopathic pulmonary fibrosis, a condition that causes scarring of the lungs. It helps slow down the progression of the disease by reducing lung inflammation and fibrosis, which can help improve breathing and lung function over time.

  • Nintedanib

    is another medication used for idiopathic pulmonary fibrosis. It works by inhibiting certain enzymes that contribute to the formation of scar tissue in the lungs. This helps to slow the decline in lung function and manage symptoms associated with the disease.

What is already known about the treatment

  • Pirfenidone

    Pirfenidone is administered orally in the form of tablets. It is currently used in the treatment of idiopathic pulmonary fibrosis, a condition characterized by progressive lung scarring. The medication works by reducing the production of certain substances in the body that cause inflammation and fibrosis, thereby slowing the progression of the disease. Pirfenidone is classified as an antifibrotic agent.

  • Nintedanib

    Nintedanib is taken orally as capsules. It is approved for use in managing idiopathic pulmonary fibrosis, helping to slow the decline in lung function. The drug acts by inhibiting multiple pathways involved in the process of fibrosis, targeting specific enzymes that contribute to tissue scarring. Nintedanib belongs to the class of tyrosine kinase inhibitors.

Investigated diseases

Idiopathic Pulmonary Fibrosis – Idiopathic pulmonary fibrosis is a chronic lung disease characterized by the progressive scarring of lung tissue. This scarring, or fibrosis, leads to a gradual decline in lung function, making it increasingly difficult for the lungs to supply oxygen to the bloodstream. The exact cause of the disease is unknown, which is why it is termed "idiopathic." Over time, individuals with this condition may experience worsening shortness of breath and a persistent dry cough. The disease typically progresses over several years, with the rate of progression varying among individuals. As the fibrosis worsens, it can lead to significant respiratory impairment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511427-34-00Protocol code69HCL19_0029Estimated enrolment378 patientsSponsorHospices Civils De Lyon

sourced from the EU Clinical Trials Register and site verification

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