A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
- Conditions
- Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis
- Interventions
- Drug: PlaceboDrug: BI 1839100
- Registration Number
- NCT06360094
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 230
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase IIa/IIb, IPF cohort: Placebo Placebo - Phase IIa/IIb, IPF cohort: BI 1839100 low dose BI 1839100 - Phase IIa/IIb, IPF cohort: BI 1839100 medium dose BI 1839100 - Phase IIa/IIb, IPF cohort: BI 1839100 high dose BI 1839100 - Phase IIb, PPF cohort: Placebo Placebo - Phase IIb, PPF cohort: BI 1839100 high dose BI 1839100 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm) At baseline, at week 4 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.
IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score At baseline, at week 4 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.
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 Leicester Cough Questionnaire (LCQ) physical domain score At baseline, at week 12 LCQ: the total score ranges from 3 to 21. A higher score indicates better cough specific quality of life.
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 At baseline, at week 12 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.
Trial Locations
- Locations (83)
Centre Hospitalier de l'Universite de Montreal (CHUM)
🇨🇦Montreal, Quebec, Canada
HOP Nord Laennec
🇫🇷Nantes, France
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The Medical Research Group
🇺🇸Fresno, California, United States
St. Francis Medical Institute
🇺🇸Clearwater, Florida, United States
University of Florida Health Shands Hospital
🇺🇸Gainesville, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Infinity Medical Research
🇺🇸North Dartmouth, Massachusetts, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Northern Westchester Hospital
🇺🇸Mount Kisco, New York, United States
Mount Sinai Hospital-New York-52529
🇺🇸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
University of Oklahoma-Oklahoma City-59108
🇺🇸Oklahoma City, Oklahoma, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Infinity Medical Research, Inc.
🇺🇸East Providence, Rhode Island, United States
Lowcountry Lung and Critical Care
🇺🇸Charleston, South Carolina, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Pulmonary and Sleep Center of the Valley
🇺🇸McAllen, Texas, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
🇦🇷C.a.b.a, Argentina
Hospital Britanico de Buenos Aires
🇦🇷Caba, Argentina
Centro de Investigación Clinica Belgrano
🇦🇷Caba, Argentina
CEDIC - Centro de Investigacion Clinica
🇦🇷Caba, Argentina
Consultorios Médicos del Buen Ayre
🇦🇷Capital Federal, Argentina
Canberra Hospital
🇦🇺Canberra, Australian Capital Territory, Australia
Lung Research Victoria
🇦🇺Footscray, Victoria, Australia
Kepler Univ. Klinikum Linz
🇦🇹Linz, Austria
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
UNIV UZ Gent
🇧🇪Gent, Belgium
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium
Liège - HOSP CHR de la Citadelle
🇧🇪Liège, Belgium
Serviços Medicos Respirar Sul Fluminense
🇧🇷Barra Mansa, Brazil
Faculdade de Medicina de Botucatu - UNESP
🇧🇷Botucatu, Brazil
CLARE - Clinica de Pneumologia
🇧🇷Goiania, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Netspiro Clinica Medica Ltda - Respsono
🇧🇷Sao Bernardo do Campo, Brazil
Hospital Alemao Oswaldo Cruz
🇧🇷Sao Paulo, Brazil
Hospital das Clinicas da FMUSP
🇧🇷São Paulo, Brazil
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Beijing Chao-Yang Hospital
🇨🇳Beijing, China
Anhui Provincial Hospital
🇨🇳Hefei, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China
Shanghai Chest Hospital
🇨🇳Shanghai, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Thomayer University Hospital
🇨🇿Prague, Czechia
Oulun yliopistollinen keskussairaala
🇫🇮Oulu, Finland
HOP d'Angers
🇫🇷Angers, France
HOP Haut-Lévêque
🇫🇷Pessac, France
HOP Charles Nicolle
🇫🇷Rouen, France
CIMS Studienzentrum Bamberg GmbH
🇩🇪Bamberg, Germany
Vivantes Netzwerk für Gesundheit GmbH
🇩🇪Berlin, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Robert Bosch Gesellschaft für medizinische Forschung mbH
🇩🇪Stuttgart, Germany
Koranyi National Institute For Pulmonolgy
🇭🇺Budapest, Hungary
Ospedale Colonnello D Avanzo
🇮🇹Foggia, Italy
Osp. S. Giuseppe Fatebenefratelli
🇮🇹Milano, Italy
Poli Univ A. Gemelli
🇮🇹Roma, Italy
Tosei General Hospital
🇯🇵Aichi, Seto, Japan
University of Fukui Hospital
🇯🇵Fukui, Yoshida-gun, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Fukuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Fukuoka, Japan
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Kanagawa, Yokohama, Japan
Kyorin University Hospital
🇯🇵Tokyo, Mitaka, Japan
Toho University Omori Medical Center
🇯🇵Tokyo, Ota-ku, Japan
Center Hospital of the National Center for Global Health and Medicine
🇯🇵Tokyo, Shinjuku-ku, Japan
Institut Perubatan Respiratori
🇲🇾Kuala Lumpur, Malaysia
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Haukeland Universitetssykehus
🇳🇴Bergen, Norway
University Clinical Hospital in Bialystok I
🇵🇱Bialystok, Poland
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
🇵🇱Warszawa, Poland
Singapore General Hospital
🇸🇬Singapore, Singapore
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Skånes universitetssjukhus, Lund
🇸🇪Lund, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Southampton General Hospital
🇬🇧Southampton, United Kingdom