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A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis

NCT06360094 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-01-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BI 1839100

BI 1839100

DRUG

Placebo

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-28
Primary Completion
2025-09-02
Completion
2025-09-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • New Zealand
  • Norway
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06360094 on ClinicalTrials.gov