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BI 1839100 for Pulmonary Fibrosis

Phase 2
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, at week 12

Summary

"This trial is looking for adults aged 40 and older with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have a chronic cough. The study aims to

Who is the study for?
Adults aged 40+ with idiopathic pulmonary fibrosis (IPF) or those aged 18+ with progressive pulmonary fibrosis (PPF), who have a chronic cough, can join this study. They must not be on certain lung fibrosis treatments for at least 12 weeks before the trial and should not plan to start them during the trial. Their lungs must function at a minimum level.
What is being tested?
The study tests if BI 1839100 reduces cough in IPF or PPF patients compared to a placebo. Participants are randomly assigned to receive different doses of BI 1839100 or placebo for three months, with their coughing measured using a portable device and through questionnaires.
What are the potential side effects?
While specific side effects aren't listed here, participants' health will be regularly checked for any unwanted effects throughout the study period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with idiopathic pulmonary fibrosis.
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I have a chronic cough for over 8 weeks due to IPF, not improved by treatments.
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I am at least 40 years old.
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I haven't taken nintedanib or pirfenidone in the last 12 weeks and don't plan to start them during the trial.
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I am 40 years old or older.
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I am at least 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, at week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm)
IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase IIb, PPF cohort: BI 1839100 high doseExperimental Treatment1 Intervention
Group II: Phase IIa/IIb, IPF cohort: BI 1839100 medium doseExperimental Treatment1 Intervention
Group III: Phase IIa/IIb, IPF cohort: BI 1839100 low doseExperimental Treatment1 Intervention
Group IV: Phase IIa/IIb, IPF cohort: BI 1839100 high doseExperimental Treatment1 Intervention
Group V: Phase IIb, PPF cohort: PlaceboPlacebo Group1 Intervention
Group VI: Phase IIa/IIb, IPF cohort: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1839100
2023
Completed Phase 1
~200

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,769,063 Total Patients Enrolled
52 Trials studying Idiopathic Pulmonary Fibrosis
47,711 Patients Enrolled for Idiopathic Pulmonary Fibrosis
~153 spots leftby Jul 2025
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