A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
NCT ID: NCT06360094
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
85 participants
INTERVENTIONAL
2024-08-28
2025-09-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Phase IIa/IIb, IPF cohort: Placebo
Placebo
Placebo
Phase IIa/IIb, IPF cohort: BI 1839100 low dose
BI 1839100
BI 1839100
Phase IIa/IIb, IPF cohort: BI 1839100 medium dose
BI 1839100
BI 1839100
Phase IIa/IIb, IPF cohort: BI 1839100 high dose
BI 1839100
BI 1839100
Phase IIb, PPF cohort: Placebo
Placebo
Placebo
Phase IIb, PPF cohort: BI 1839100 high dose
BI 1839100
BI 1839100
Interventions
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BI 1839100
BI 1839100
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado, United States
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, 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
Northern Westchester Hospital
Mount Kisco, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
New Bern, North Carolina, United States
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina, United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
A & A Research Consultants, LLC
Edinburg, Texas, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States
Launceston Respiratory & Sleep Centre
Launceston, Tasmania, Australia
Lung Research Victoria
Footscray, Victoria, Australia
CHR de la Citadelle
Liège, , Belgium
Gordon & Leslie Diamond Health Care Centre (UBC)
Vancouver, British Columbia, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
The Second Xiangya Hospital Of Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
People's Hospital of Sichuan Province
Chengdu, , China
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Zhejiang Hospital
Hangzhou, , China
Anhui Provincial Hospital
Hefei, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Shanghai Pulmonary Hospital
Shanghai, , China
China Shenyang Chest Hospital
Shenyang, , China
Tianjin Medical University General Hospital
Tianjin, , China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, , China
University Thomayer´s Hospital
Prague, , Czechia
Odense University Hospital
Odense, , Denmark
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, , Finland
Oulun yliopistollinen keskussairaala
Oulu, , Finland
TYKS
Turku, , Finland
HOP d'Angers
Angers, , France
HOP Avicenne
Bobigny, , France
HOP CHU Caen
Caen, , France
HOP Michallon
La Tronche, , France
HOP Nord Laennec
Nantes, , France
HOP Bretonneau
Tours, , France
Universitätsklinikum Aachen, AöR
Aachen, , Germany
CIMS Studienzentrum Bamberg GmbH
Bamberg, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, , Germany
Krankenhaus Bethanien gGmbH
Solingen, , Germany
Hospital of Heraklion (PAGNI)
Crete, , Greece
Univ. Gen. Hosp. of Patras
Pátrai, , Greece
Ospedale Classificato San Giuseppe
Milan, , Italy
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
Pol. Universitario Tor Vergata
Roma, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, , Italy
University of Fukui Hospital
Fukui, Yoshida-gun, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, Fukuoka, , Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, , Japan
National Hospital Organization Himeji Medical Center
Hyogo, Himeji, , Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, , Japan
Tokushima University Hospital
Tokushima, Tokushima, , Japan
Toho University Omori Medical Center
Tokyo, Ota-ku, , Japan
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, , Japan
Hospital Sultan Idris Shah Serdang
Kajang, , Malaysia
Institut Perubatan Respiratori
Kuala Lumpur, , Malaysia
Amphia Ziekenhuis
Breda, , Netherlands
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, , Netherlands
Christchurch Hospital
Christchurch, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Greenlane Clinical Centre
One Tree Hill, Auckland, , New Zealand
Haukeland Universitetssykehus
Bergen, , Norway
Akershus Universitetssykehus HF
Lørenskog, , Norway
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, , Norway
Singapore General Hospital
Singapore, , Singapore
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Hospital de Galdakao
Galdakao, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Central de Asturias
Oviedo, , Spain
Hospital Quirónsalud Madrid
Pozuelo de Alarcón, , Spain
Skånes universitetssjukhus, Lund
Lund, , Sweden
CTC Clinical Trial Consultants AB
Uppsala, , Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chulalongkorn Hospital
Bangkok, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Ramathibodi Hospital
Ratchatewi, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Royal Devon and Exeter Hospital, Wonford
Exeter, , United Kingdom
Royal Lancaster Infirmary
Lancaster, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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2023-510249-79-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1301-1311
Identifier Type: REGISTRY
Identifier Source: secondary_id
1490-0004
Identifier Type: -
Identifier Source: org_study_id
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