Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

TERMINATED

NCT06360094

PHASE2

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-28

Completion Date

2025-09-02

Last Updated

2026-09-23

Healthy Volunteers

Conditions

Idiopathic Pulmonary Fibrosis Progressive Pulmonary Fibrosis

Interventions

DRUG

BI 1839100

DRUG

Placebo

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.

Locations (99)

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, 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

Padova, Italy

Pol. Universitario Tor Vergata

Roma, Italy

Fondazione Policlinico Universitario Agostino 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