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

NCT06360094 | Terminated Phase 2 DMC FDA Drug

• 3 other identifiers: 1490-00042023-510249-79-00U1111-1301-1311
• Study Type: interventional
• Target: 85
• Locations: 24 countries
• Sites: 99

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.

Conditions

Idiopathic Pulmonary Fibrosis; Progressive Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score

  At baseline, at week 4

• IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm)

  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

Study Arms (6)

Phase IIa/IIb, IPF cohort: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Phase IIa/IIb, IPF cohort: BI 1839100 low dose

EXPERIMENTAL

Drug: BI 1839100

Phase IIa/IIb, IPF cohort: BI 1839100 medium dose

EXPERIMENTAL

Drug: BI 1839100

Phase IIa/IIb, IPF cohort: BI 1839100 high dose

EXPERIMENTAL

Drug: BI 1839100

Phase IIb, PPF cohort: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Phase IIb, PPF cohort: BI 1839100 high dose

EXPERIMENTAL

Drug: BI 1839100

Interventions

Placebo DRUG

Placebo

Phase IIa/IIb, IPF cohort: Placebo; Phase IIb, PPF cohort: Placebo

BI 1839100 DRUG

BI 1839100

Phase IIa/IIb, IPF cohort: BI 1839100 high dose; Phase IIa/IIb, IPF cohort: BI 1839100 low dose; Phase IIa/IIb, IPF cohort: BI 1839100 medium dose; Phase IIb, PPF cohort: BI 1839100 high dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (99)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Critical Care, Pulmonary and Sleep Associates

Lakewood, Colorado, 80228, United States

Location

Clinical Research Specialists LLC - Kissimmee

Kissimmee, Florida, 34746, United States

Location

The Iowa Clinic, PC

West Des Moines, Iowa, 50266, United States

Location

Advanced Pulmonary Research

Warren, Michigan, 48088, United States

Location

Memorial Hospital Gulfport

Gulfport, Mississippi, 39501, United States

Location

Northern Westchester Hospital

Mount Kisco, New York, 10549, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center-New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine

New Bern, North Carolina, 28562, United States

Location

Southeastern Research Center-Winston Salem-69289

Winston-Salem, North Carolina, 27103, United States

Location

Clinical Research Associates of Central PA

DuBois, Pennsylvania, 15801, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Lowcountry Lung and Critical Care

Charleston, South Carolina, 29406, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

A & A Research Consultants, LLC

Edinburg, Texas, 78539, United States

Location

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, 23230, United States

Location

Launceston Respiratory & Sleep Centre

Launceston, Tasmania, 7250, Australia

Location

Lung Research Victoria

Footscray, Victoria, 3011, Australia

Location

CHR de la Citadelle

Liège, 4000, Belgium

Location

Gordon & Leslie Diamond Health Care Centre (UBC)

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

The Second Xiangya Hospital Of Central South University

Changsha, 410011, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

People's Hospital of Sichuan Province

Chengdu, 610072, China

Location

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120, China

Location

Zhejiang Hospital

Hangzhou, 310013, China

Location

Anhui Provincial Hospital

Hefei, 230001, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

China Shenyang Chest Hospital

Shenyang, 110000, China

Location

Tianjin Medical University General Hospital

Tianjin, 30052, China

Location

Affiliated Hospital, Xuzhou Medical college

Xuzhou, 221009, China

Location

University Thomayer´s Hospital

Prague, 140 59, Czechia

Location

Odense University Hospital

Odense, 5000, Denmark

Location

HYKS Keuhkosairauksien tutkimusyksikkö

Helsinki, 00029, Finland

Location

Oulun yliopistollinen keskussairaala

Oulu, 90220, Finland

Location

TYKS

Turku, 20520, Finland

Location

HOP d'Angers

Angers, 49933, France

Location

HOP Avicenne

Bobigny, 93000, France

Location

HOP CHU Caen

Caen, 14033, France

Location

HOP Michallon

La Tronche, 38700, France

Location

HOP Nord Laennec

Nantes, 44093, France

Location

HOP Bretonneau

Tours, 37000, France

Location

Universitätsklinikum Aachen, AöR

Aachen, 52074, Germany

Location

CIMS Studienzentrum Bamberg GmbH

Bamberg, 96049, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45239, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Krankenhaus Bethanien gGmbH

Solingen, 42699, Germany

Location

Hospital of Heraklion (PAGNI)

Crete, 71500, Greece

Location

Univ. Gen. Hosp. of Patras

Pátrai, 26504, Greece

Location

Ospedale Classificato San Giuseppe

Milan, 20123, Italy

Location

Azienda Ospedaliera Universitaria di Padova

Padua, 35128, Italy

Location

Pol. Universitario Tor Vergata

Roma, 00133, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

University of Fukui Hospital

Fukui, Yoshida-gun, 910-1193, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, 810-8563, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Sapporo Medical University Hospital

Hokkaido, Sapporo, 060-8543, Japan

Location

National Hospital Organization Himeji Medical Center

Hyogo, Himeji, 670-8520, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Kanagawa, Yokohama, 236-0051, Japan

Location

Tokushima University Hospital

Tokushima, Tokushima, 770-8503, Japan

Location

Toho University Omori Medical Center

Tokyo, Ota-ku, 143-8541, Japan

Location

National Center for Global Health and Medicine

Tokyo, Shinjuku-ku, 162-8655, Japan

Location

Hospital Sultan Idris Shah Serdang

Kajang, 43000, Malaysia

Location

Institut Perubatan Respiratori

Kuala Lumpur, 53000, Malaysia

Location

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

Location

Erasmus Medisch Centrum-ROTTERDAM-50697

Rotterdam, 3015 GD, Netherlands

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Waikato Hospital

Hamilton, 3240, New Zealand

Location

Greenlane Clinical Centre

One Tree Hill, Auckland, 1051, New Zealand

Location

Haukeland Universitetssykehus

Bergen, N-5021, Norway

Location

Akershus Universitetssykehus HF

Lørenskog, 1478, Norway

Location

Oslo Universitetssykehus HF, Rikshospitalet

Oslo, N-0372, Norway

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Inje University Sanggye Paik Hospital

Seoul, 01757, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hospital Universitari Vall D Hebron

Barcelona, 08035, Spain

Location

Hospital de Galdakao

Galdakao, 48960, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Quirónsalud Madrid

Pozuelo de Alarcón, 28223, Spain

Location

Skånes universitetssjukhus, Lund

Lund, 221 85, Sweden

Location

CTC Clinical Trial Consultants AB

Uppsala, 752 37, Sweden

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Ramathibodi Hospital

Ratchatewi, 10400, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Royal Devon and Exeter Hospital, Wonford

Exeter, EX2 5DW, United Kingdom

Location

Royal Lancaster Infirmary

Lancaster, LA1 4RP, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 11, 2024
• Study Start: August 28, 2024
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

TW (2); ES (5); FI (3); DE (7); GB (5); JP (9); SE (2); AU (2); CZ (1); US (18); NL (2); BE (1); SG (1); TH (4); GR (2); CN (11); IT (4); MY (2); NZ (3); CA (3); FR (6); KR (2); NO (3); DK (1)