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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510249-79-00
Acronym
1490-0004
Enrollment
100
Registered
2024-08-23
Start date
2024-09-10
Completion date
2025-09-02
Last updated
2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis (IPF), Progressive pulmonary fibrosis (PPF)

Brief summary

IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (CC/h) at Week 4, IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (CC/h) at Week 12

Detailed description

IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity NRS score at Week 4, IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity VAS score (mm) at Week 4, IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% 24-h cough frequency reduction (CC/h) from baseline at Week 12, IPF cohort - Phase IIb: Absolute change from baseline in FVC (mL) at Week 12, IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score at Week 12

Interventions

DRUGBI 1839100
DRUGPlacebo matching in size
DRUGweight
DRUGcolour and shape to tablets of BI 1839100

Sponsors

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (CC/h) at Week 4, IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (CC/h) at Week 12—

Secondary

MeasureTime frame
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity NRS score at Week 4, IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity VAS score (mm) at Week 4, IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% 24-h cough frequency reduction (CC/h) from baseline at Week 12, IPF cohort - Phase IIb: Absolute change from baseline in FVC (mL) at Week 12, IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score at Week 12—

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026