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

Phase 2

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis; Progressive Pulmonary Fibrosis
• Interventions: Drug: Placebo; Drug: BI 1839100

• Registration Number: NCT06360094
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-11
• Study Start: 2024-08-28
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-08
• Primary Completion: 2026-03-18
• Study Completion: 2026-03-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase IIa/IIb, IPF cohort: Placebo	Placebo	-
Phase IIa/IIb, IPF cohort: BI 1839100 low dose	BI 1839100	-
Phase IIa/IIb, IPF cohort: BI 1839100 medium dose	BI 1839100	-
Phase IIb, PPF cohort: Placebo	Placebo	-
Phase IIb, PPF cohort: BI 1839100 high dose	BI 1839100	-
Phase IIa/IIb, IPF cohort: BI 1839100 high dose	BI 1839100	-

Primary Outcome Measures

Name	Time	Method
IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h)	At baseline, at week 4
IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h)	At baseline, at week 12

Secondary Outcome Measures

Name	Time	Method
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm)	At baseline, at week 4	VAS: the cough severity VAS is scored according to the distance between no cough (0) and the mark set by the participant, with higher distance indicating higher severity of cough.
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score	At baseline, at week 4	NRS: a single-item patient reported outcome measure to assess cough severity on a 11-point numerical rating scale ranging from 0 (no cough) to 10 (worst possible cough) with a recall period of the past 7 days. Higher scores indicate higher severity of cough.
IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% reduction in 24-h cough frequency (CC/h)	At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL)	At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score	At baseline, at week 12	LCQ: the total score ranges from 3 to 21. A higher score indicates better cough specific quality of life.
IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score	At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm)	At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score	At baseline, at week 12	L-PF: the L-PF symptom module domain and total scores as well as the L-PF impact module total score ranges from 0 to 100, with higher scores indicating a greater impairment.

Trial Locations

Locations (180)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Critical Care, Pulmonary and Sleep Associates; 🇺🇸 Lakewood, Colorado, United States

Clinical Research Specialists LLC; 🇺🇸 Kissimmee, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

The Iowa Clinic, PC; 🇺🇸 West Des Moines, Iowa, United States

Advanced Pulmonary Research; 🇺🇸 Warren, Michigan, United States

Memorial Hospital Gulfport; 🇺🇸 Gulfport, Mississippi, United States

Renown Regional Medical Center; 🇺🇸 Reno, Nevada, United States

Northern Westchester Hospital; 🇺🇸 Mount Kisco, New York, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

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