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Testing BI 1839100 for cough relief in pulmonary fibrosis patients

A Phase IIa/IIb, Randomised, Double Blind, Placebo-controlled, Parallel-group Dose-finding Study to Examine the Efficacy and Safety of BI 1839100 Administered Orally Over a 12-week Treatment Period in Patients With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis With Clinically Meaningful Cough

Phase 2 Interventional Boehringer Ingelheim · NCT06360094

This study is testing a new medication called BI 1839100 to see if it can help adults with pulmonary fibrosis who have a chronic cough feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment230 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations180 sites (Birmingham, Alabama and 179 other locations)
Trial IDNCT06360094 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of BI 1839100 in reducing chronic cough in adults with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). Participants aged 40 and older with IPF or 18 and older with PPF who have a chronic cough will be randomly assigned to receive either BI 1839100 at varying doses or a placebo for three months. The study will measure cough severity and lung function to determine the treatment's efficacy. Participants will have multiple visits to the study site over a period of slightly more than four months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a diagnosis of idiopathic pulmonary fibrosis and a chronic cough that has not responded to other treatments.

Not a fit: Patients without chronic cough or those with other underlying conditions that may cause cough may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cough symptoms and overall quality of life for patients with pulmonary fibrosis.

How similar studies have performed: Other studies have explored treatments for cough in pulmonary fibrosis, but the specific approach with BI 1839100 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

For Idiopathic Pulmonary Fibrosis (IPF) cohort:

* Minimum age: 40 years
* Diagnosis of IPF
* Chronic cough (\>8 weeks prior to Visit 1) attributed to IPF and refractory to treatment for known causes (Principal Investigator (PI) assessment)
* Cough Severity visual analogue scale (VAS) ≥30 mm at Visit 1 and Visit 2B
* Forced vital capacity (FVC) ≥45% of predicted normal at Visit 1
* Diffusing capacity of the lungs for carbon monoxide (DLCO) \>25% of predicted normal at Visit 1
* Patients may be either:

  * On stable therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration. Combination of nintedanib plus pirfenidone will not be allowed
  * Not on therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 (either antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial
* Patients aged ≥40 years when signing the informed consent

For Progressive Pulmonary Fibrosis (PPF) cohort:

* Minimum age: 18 years
* Diagnosis of PPF
* Chronic cough (\>8 weeks prior to Visit 1) attributed to PPF, refractory to treatment for known causes (PI assessment)
* Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B
* FVC ≥45% of predicted normal at Visit 1
* DLCO ≥25% of predicted normal at Visit 1
* If receiving immunomodulatory therapy for interstitial lung disease (ILD), allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine (stable dose for 12 weeks prior to Visit 1)
* Patients may be either:

  * On a stable therapy with nintedanib for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration
  * Not on a therapy with nintedanib for ≥12 weeks prior to Visit 1 (either AF-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial
* Patients aged \>18 years when signing the informed consent Further inclusion criteria apply.

Exclusion criteria for IPF and PPF cohorts:

* Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1
* Forced expiratory volume in 1 second (Forced expiratory volume in 1 second (FEV1))/FVC \<0.7 at Visit 1
* Known reversible airflow obstruction/response to bronchodilators
* In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including primary bronchitic and bronchiectatic disorder
* Upper or lower respiratory tract infection within 4 weeks prior to Visit 1
* Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)
* Current smokers (tobacco use within the 6 months prior to Visit 1)
* Initiation or change in supplemental oxygen requirement during 4 weeks prior to Visit 1 Further exclusion criteria apply.

Where this trial is running

Birmingham, Alabama and 179 other locations

+130 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.