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Study on BI 1839100 for Reducing Cough in Patients with Idiopathic or Progressive Pulmonary Fibrosis

Fast replyInvestigationalNo 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 two lung diseases: Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF). These conditions are characterized by scarring of the lung tissue, which can lead to a persistent cough and difficulty breathing. The trial will test a new treatment called BI 1839100, which is taken as a film-coated tablet. The purpose of the study is to see if this medication can help reduce cough in people with these lung conditions.

Participants in the study will be randomly assigned to receive either the BI 1839100 tablet or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for 12 weeks, during which the participants will take the medication orally. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

The main goal is to observe any changes in the frequency of coughing over the course of the study. Researchers will also look at how different doses of BI 1839100 affect cough frequency and assess the safety of the medication. This study aims to provide valuable information on whether BI 1839100 can be an effective treatment for reducing cough in patients with Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis.

The research process

The trial runs in 5 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 receive either the medication BI 1839100 or a placebo. The placebo is designed to look identical to the medication to ensure the study remains unbiased.

    The medication is administered in the form of a film-coated tablet and is taken orally.

  2. Step 2

    Initial treatment phase

    During the first 4 weeks, the patient will take the assigned tablet daily. The goal is to observe any changes in the frequency of cough over a 24-hour period.

    The study aims to determine if there is a significant reduction in cough frequency in patients taking the highest dose of BI 1839100 compared to those taking the placebo.

  3. Step 3

    Extended treatment phase

    The treatment continues for a total of 12 weeks. Throughout this period, the patient will continue to take the daily tablet.

    The study will assess the dose-response relationship, which means understanding how different doses of BI 1839100 affect cough frequency and safety.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient will undergo regular assessments to monitor changes in cough frequency and severity. This includes measuring the cough frequency over 24 hours and evaluating the severity using specific scoring systems.

    The study will also track any changes in lung function and overall health to ensure the safety and effectiveness of the treatment.

  5. Step 5

    Completion of the study

    At the end of the 12-week period, the patient will complete the study. Final assessments will be conducted to gather comprehensive data on the treatment's impact.

    The results will contribute to understanding the potential benefits of BI 1839100 for patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.

Who can join the trial?

17 criteria

  • For the **IPF cohort** (Idiopathic Pulmonary Fibrosis):
    • Must have a diagnosis of **IPF**.
    • Must have a **chronic cough** lasting more than 8 weeks, which is not responding to treatment for known causes.
    • Must have a **Cough Severity VAS** (Visual Analog Scale) score of 30 mm or more at specific visits.
    • Must have a **FVC** (Forced Vital Capacity) of 45% or more of what is predicted as normal at a specific visit. FVC is a measure of lung function.
    • Must have a **DLCO** (Diffusing Capacity of the Lungs for Carbon Monoxide) of more than 25% of what is predicted as normal at a specific visit. DLCO measures how well the lungs transfer gas from the air to the blood.
    • Must be on a stable therapy with **nintedanib** or **pirfenidone** for at least 12 weeks before a specific visit and plan to continue this treatment throughout the trial. Combination of both drugs is not allowed. Alternatively, must not be on these therapies for at least 12 weeks before a specific visit and do not plan to start or restart them during the trial.
    • Must be aged 40 years or older when signing the informed consent.
    • For the **PPF cohort** (Progressive Pulmonary Fibrosis):
      • Must have a diagnosis of **PPF**.
      • Must have a **chronic cough** lasting more than 8 weeks, which is not responding to treatment for known causes.
      • Must have a **Cough Severity VAS** score of 30 mm or more at specific visits.
      • Must have a **FVC** of 45% or more of what is predicted as normal at a specific visit.
      • Must have a **DLCO** of more than 25% of what is predicted as normal at a specific visit.
      • If receiving **immunomodulatory therapy** for ILD (Interstitial Lung Disease), allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine, and the dose must be stable for 12 weeks before a specific visit.
      • Must be on a stable therapy with **nintedanib** for at least 12 weeks before a specific visit and plan to continue this treatment throughout the trial. Alternatively, must not be on this therapy for at least 12 weeks before a specific visit and do not plan to start or restart it during the trial.
      • Must be aged over 18 years when signing the informed consent.
      • Both male and female participants are eligible.
      • Participants should not belong to a vulnerable population.

Who cannot join the trial?

8 criteria

  • Patients with any other lung disease besides Idiopathic Pulmonary Fibrosis (IPF) or Progressive Pulmonary Fibrosis (PPF) cannot participate. These are specific lung conditions that cause scarring in the lungs.
  • Patients who have had a recent lung infection or illness that affects their breathing may be excluded.
  • Patients who are currently taking medications that could interfere with the study drug may not be eligible.
  • Patients with a history of severe allergies or reactions to medications might be excluded.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients with certain heart conditions or other serious health issues may be excluded.
  • Patients who have participated in another clinical trial recently might not be eligible.
  • Patients who are unable to comply with the study procedures or follow-up visits may be excluded.
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Investigated drugs

BI 1839100 is an investigational medication being studied for its potential to reduce cough frequency in patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis. This medication is taken orally and is being tested to see how effective and safe it is over a 12-week treatment period. The study aims to find the right dose that can significantly decrease the number of coughs a patient experiences in a day.

What is already known about the treatment

BI 1839100 – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It is in the Phase IIa/IIb stage of clinical trials, focusing on its efficacy and safety in reducing cough frequency in patients with these conditions. The main therapeutic indication is to alleviate cough associated with pulmonary fibrosis. At the molecular level, BI 1839100 is believed to work by modulating pathways involved in cough reflex and inflammation, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational drug, as it is not yet approved for general medical use.

Investigated diseases

  • Idiopathic Pulmonary Fibrosis (IPF)

    A chronic lung disease characterized by the thickening and scarring of lung tissue, leading to a progressive decline in lung function. The cause of IPF is unknown, and it primarily affects middle-aged and older adults. As the disease progresses, the scarring makes it increasingly difficult for the lungs to transfer oxygen into the bloodstream. Patients often experience a persistent dry cough and shortness of breath, which worsen over time. The disease can lead to a significant reduction in the ability to perform daily activities due to breathing difficulties.

  • Progressive Pulmonary Fibrosis (PPF)

    A condition where lung tissue becomes damaged and scarred over time, leading to a gradual worsening of lung function. This disease can arise from various underlying causes, including other lung conditions or environmental exposures. As fibrosis progresses, patients may experience increasing breathlessness and a chronic cough. The scarring of lung tissue reduces the lungs' ability to expand and contract, making breathing more difficult. Over time, the disease can severely impact the quality of life due to the progressive nature of the symptoms.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510249-79-00Protocol code1490-0004Estimated enrolment232 patientsSponsorBoehringer Ingelheim Espana S.A.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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