A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
Public ClinicalTrials.gov record NCT06360094. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF. Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF. During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.
Study identification
- NCT ID
- NCT06360094
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 85 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 27, 2024
- Primary completion
- Sep 1, 2025
- Completion
- Sep 1, 2025
- Last update posted
- Jan 20, 2026
2024 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Critical Care, Pulmonary and Sleep Associates | Lakewood | Colorado | 80228 | — |
| Clinical Research Specialists LLC - Kissimmee | Kissimmee | Florida | 34746 | — |
| The Iowa Clinic, PC | West Des Moines | Iowa | 50266 | — |
| Advanced Pulmonary Research | Warren | Michigan | 48088 | — |
| Memorial Hospital Gulfport | Gulfport | Mississippi | 39501 | — |
| Northern Westchester Hospital | Mount Kisco | New York | 10549 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine | New Bern | North Carolina | 28562 | — |
| Southeastern Research Center-Winston Salem-69289 | Winston-Salem | North Carolina | 27103 | — |
| Clinical Research Associates of Central PA | DuBois | Pennsylvania | 15801 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Lowcountry Lung and Critical Care | Charleston | South Carolina | 29406 | — |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | — |
| A & A Research Consultants, LLC | Edinburg | Texas | 78539 | — |
| Pulmonary Associates of Richmond, Inc. | Richmond | Virginia | 23230 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 81 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06360094, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 20, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06360094 live on ClinicalTrials.gov.