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

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

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 Overview

• Status: Terminated
• Conditions: Idiopathic Pulmonary Fibrosis; Progressive Pulmonary Fibrosis
• Intervention / Treatment: Drug: Placebo; Drug: BI 1839100

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Tasmania
    • Launceston, Tasmania, Australia, 7250
      • Launceston Respiratory & Sleep Centre
  • Victoria
    • Footscray, Victoria, Australia, 3011
      • Lung Research Victoria
• Belgium
  • Liège, Belgium, 4000
    • CHR de la Citadelle
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Gordon & Leslie Diamond Health Care Centre (UBC)
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre hospitalier de l'Université de Montréal (CHUM)
• China
  • Changsha, China, 410011
    • The Second Xiangya Hospital of Central South University
  • Chengdu, China, 610041
    • West China Hospital of Sichuan University
  • Chengdu, China, 610072
    • People's Hospital of Sichuan Province
  • Guangzhou, China, 510120
    • First Affiliated Hospital of Guangzhou Medical University
  • Hangzhou, China, 310013
    • Zhejiang Hospital
  • Hefei, China, 230001
    • Anhui Provincial Hospital
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Shanghai, China, 200433
    • Shanghai Pulmonary Hospital
  • Shenyang, China, 110000
    • China Shenyang Chest Hospital
  • Tianjin, China, 30052
    • Tianjin Medical University General Hospital
  • Xuzhou, China, 221009
    • Affiliated Hospital, Xuzhou Medical college
• Czechia
  • Prague, Czechia, 140 59
    • University Thomayer´s Hospital
• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital
• Finland
  • Helsinki, Finland, 00029
    • HYKS Keuhkosairauksien tutkimusyksikkö
  • Oulu, Finland, 90220
    • Oulun yliopistollinen keskussairaala
  • Turku, Finland, 20520
    • TYKS
• France
  • Angers, France, 49933
    • HOP d'Angers
  • Bobigny, France, 93000
    • HOP Avicenne
  • Caen, France, 14033
    • HOP CHU Caen
  • La Tronche, France, 38700
    • HOP Michallon
  • Nantes, France, 44093
    • HOP Nord Laennec
  • Tours, France, 37000
    • HOP Bretonneau
• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen, AöR
  • Bamberg, Germany, 96049
    • CIMS Studienzentrum Bamberg GmbH
  • Essen, Germany, 45239
    • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  • Freiburg im Breisgau, Germany, 79106
    • Universitatsklinikum Freiburg
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69126
    • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
  • Solingen, Germany, 42699
    • Krankenhaus Bethanien gGmbH
• Greece
  • Crete, Greece, 71500
    • Hospital of Heraklion (PAGNI)
  • Pátrai, Greece, 26504
    • Univ. Gen. Hosp. of Patras
• Italy
  • Milan, Italy, 20123
    • Ospedale Classificato San Giuseppe
  • Padua, Italy, 35128
    • Azienda Ospedaliera Universitaria di Padova
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
  • Roma, Italy, 00133
    • Pol. Universitario Tor Vergata
• Japan
  • Fukui, Yoshida-gun, Japan, 910-1193
    • University of Fukui Hospital
  • Fukuoka, Fukuoka, Japan, 810-8563
    • National Hospital Organization Kyushu Medical Center
  • Fukuoka, Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Hokkaido, Sapporo, Japan, 060-8543
    • Sapporo Medical University Hospital
  • Hyogo, Himeji, Japan, 670-8520
    • National Hospital Organization Himeji Medical Center
  • Kanagawa, Yokohama, Japan, 236-0051
    • Kanagawa Cardiovascular and Respiratory Center
  • Tokushima, Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Tokyo, Ota-ku, Japan, 143-8541
    • Toho University Omori Medical Center
  • Tokyo, Shinjuku-ku, Japan, 162-8655
    • National Center for Global Health and Medicine
• Malaysia
  • Kajang, Malaysia, 43000
    • Hospital Sultan Idris Shah Serdang
  • Kuala Lumpur, Malaysia, 53000
    • Institut Perubatan Respiratori
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus Medisch Centrum-ROTTERDAM-50697
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • One Tree Hill, Auckland, New Zealand, 1051
    • Greenlane Clinical Centre
• Norway
  • Bergen, Norway, N-5021
    • Haukeland Universitetssykehus
  • Lørenskog, Norway, 1478
    • Akershus Universitetssykehus HF
  • Oslo, Norway, N-0372
    • Oslo Universitetssykehus HF, Rikshospitalet
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
• South Korea
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 01757
    • Inje University Sanggye Paik Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d Hebron
  • Galdakao, Spain, 48960
    • Hospital de Galdakao
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Oviedo, Spain, 33011
    • Hospital Central de Asturias
  • Pozuelo de Alarcón, Spain, 28223
    • Hospital Quirónsalud Madrid
• Sweden
  • Lund, Sweden, 221 85
    • Skånes universitetssjukhus, Lund
  • Uppsala, Sweden, 752 37
    • CTC Clinical Trial Consultants AB
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
  • Ratchatewi, Thailand, 10400
    • Ramathibodi Hospital
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital
• United Kingdom
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital, Wonford
  • Lancaster, United Kingdom, LA1 4RP
    • Royal Lancaster Infirmary
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • Manchester, United Kingdom, M23 9LT
    • Wythenshawe Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Critical Care, Pulmonary and Sleep Associates
  • Florida
    • Kissimmee, Florida, United States, 34746
      • Clinical Research Specialists LLC - Kissimmee
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic, PC
  • Michigan
    • Warren, Michigan, United States, 48088
      • Advanced Pulmonary Research
  • Mississippi
    • Gulfport, Mississippi, United States, 39501
      • Memorial Hospital Gulfport
  • New York
    • Mount Kisco, New York, United States, 10549
      • Northern Westchester Hospital
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10032
      • Columbia University Medical Center-New York Presbyterian Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • New Bern, North Carolina, United States, 28562
      • Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center-Winston Salem-69289
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Clinical Research Associates of Central PA
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lowcountry Lung and Critical Care
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Texas
    • Edinburg, Texas, United States, 78539
      • A & A Research Consultants, LLC
  • Virginia
    • Richmond, Virginia, United States, 23230
      • Pulmonary Associates of Richmond, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

For Idiopathic Pulmonary Fibrosis (IPF) cohort:

• Minimum age: 40 years
• 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)
• Cough Severity visual analogue scale (VAS) ≥30 mm at Visit 1 and Visit 2B
• Forced vital capacity (FVC) ≥45% of predicted normal at Visit 1
• Diffusing capacity of the lungs for carbon monoxide (DLCO) >25% of predicted normal at Visit 1

• Patients may be either:

  • On stable therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration. Combination of nintedanib plus pirfenidone will not be allowed
  • Not on therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 (either antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial
• Patients aged ≥40 years when signing the informed consent

For Progressive Pulmonary Fibrosis (PPF) cohort:

• Minimum age: 18 years
• Diagnosis of PPF
• Chronic cough (>8 weeks prior to Visit 1) attributed to PPF, refractory to treatment for known causes (PI assessment)
• Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B
• FVC ≥45% of predicted normal at Visit 1
• DLCO ≥25% of predicted normal at Visit 1
• If receiving immunomodulatory therapy for interstitial lung disease (ILD), allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine (stable dose for 12 weeks prior to Visit 1)

• Patients may be either:

  • On a stable therapy with nintedanib for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration
  • Not on a therapy with nintedanib for ≥12 weeks prior to Visit 1 (either AF-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial
• Patients aged >18 years when signing the informed consent Further inclusion criteria apply.

Exclusion criteria for IPF and PPF cohorts:

• Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1
• Forced expiratory volume in 1 second (Forced expiratory volume in 1 second (FEV1))/FVC <0.7 at Visit 1
• Known reversible airflow obstruction/response to bronchodilators
• In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including primary bronchitic and bronchiectatic disorder
• Upper or lower respiratory tract infection within 4 weeks prior to Visit 1
• Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)
• Current smokers (tobacco use within the 6 months prior to Visit 1)
• Initiation or change in supplemental oxygen requirement during 4 weeks prior to Visit 1 Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Phase IIa/IIb, IPF cohort: Placebo	Drug: Placebo; Placebo
Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 low dose	Drug: BI 1839100; BI 1839100
Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 medium dose	Drug: BI 1839100; BI 1839100
Experimental: Phase IIa/IIb, IPF cohort: BI 1839100 high dose	Drug: BI 1839100; BI 1839100
Placebo Comparator: Phase IIb, PPF cohort: Placebo	Drug: Placebo; Placebo
Experimental: Phase IIb, PPF cohort: BI 1839100 high dose	Drug: BI 1839100; BI 1839100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score	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.	At baseline, at week 4
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm)	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.	At baseline, at week 4
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 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	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.	At baseline, at week 12
IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score	LCQ: the total score ranges from 3 to 21. A higher score indicates better cough specific quality of life.	At baseline, at week 12

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Actual): September 2, 2025
• Study Completion (Actual): September 2, 2025

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 1490-0004; 2023-510249-79-00 (Registry Identifier: CTIS); U1111-1301-1311 (Registry Identifier: WHO Registry (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No