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: Placebo
- 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 IIb, PPF cohort: Placebo Placebo - Phase IIb, PPF cohort: BI 1839100 high dose BI 1839100 - Phase IIa/IIb, IPF 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 (180)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Critical Care, Pulmonary and Sleep Associates
🇺🇸Lakewood, Colorado, United States
Clinical Research Specialists LLC
🇺🇸Kissimmee, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, 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
Renown Regional Medical Center
🇺🇸Reno, Nevada, 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
University of Oklahoma-Oklahoma City-59108
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research Associates of Central PA
🇺🇸DuBois, Pennsylvania, United States
Hospital of Heraklion (PAGNI)
🇬🇷Voutes, Greece
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
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Pulmonary Associates of Richmond, Inc.
🇺🇸Richmond, Virginia, 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
Royal Prince Alfred Hospital
🇦🇺Camperdown, Sydney, New South Wales, Australia
Macquarie University
🇦🇺Macquarie Park, New South Wales, Australia
Launceston Respiratory & Sleep Centre
🇦🇺Launceston, Tasmania, Australia
Lung Research Victoria
🇦🇺Footscray, Victoria, Australia
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Institute for Respiratory Health
🇦🇺Nedlands, Western Australia, Australia
Medical University of Graz State Hospital - University Hospital Graz
🇦🇹Graz, Austria
Krems University Hospital
🇦🇹Krems, Austria
Kepler Univ. Klinikum Linz
🇦🇹Linz, Austria
Hospital Elisabethinen Linz
🇦🇹Linz, Austria
Clinic Floridsdorf
🇦🇹Vienna, Austria
Klinikum Wels - Grieskirchen GmbH
🇦🇹Wels, 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
Gordon & Leslie Diamond Health Care Centre (UBC)
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital (Vancouver)
🇨🇦Vancouver, British Columbia, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
🇨🇦Montreal, Quebec, Canada
CIC Mauricie Inc.
🇨🇦Trois-Rivieres, Quebec, Canada
Beijing Chao-Yang Hospital
🇨🇳Beijing, China
The Second Xiangya Hospital Of Central South University
🇨🇳Changsha, China
West China Hospital
🇨🇳Chengdu, China
People's Hospital of Sichuan Province
🇨🇳Chengdu, China
First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, China
Zhejiang Hospital
🇨🇳Hangzhou, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
🇨🇳Hangzhou, China
Anhui Provincial Hospital
🇨🇳Hefei, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China
Shanghai Chest Hospital
🇨🇳Shanghai, 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
Thomayer University 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
INS Coeur Poumon
🇫🇷Lille, France
HOP Nord
🇫🇷Marseille, France
HOP Nord Laennec
🇫🇷Nantes, France
HOP Bichat
🇫🇷Paris, France
HOP Haut-Lévêque
🇫🇷Pessac, France
HOP Charles Nicolle
🇫🇷Rouen, France
HOP Bretonneau
🇫🇷Tours, France
Universitätsklinikum Aachen, AöR
🇩🇪Aachen, Germany
CIMS Studienzentrum Bamberg GmbH
🇩🇪Bamberg, Germany
Vivantes Netzwerk für Gesundheit GmbH
🇩🇪Berlin, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
🇩🇪Essen, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Universitätsklinikum Hamburg, Eppendorf
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Krankenhaus Bethanien gGmbH
🇩🇪Solingen, Germany
Helios Hanseklinikum Stralsund
🇩🇪Stralsund, Germany
Robert Bosch Gesellschaft für medizinische Forschung mbH
🇩🇪Stuttgart, Germany
Klinikum Würzburg Mitte gGmbH
🇩🇪Würzburg, Germany
Univ. Gen. Hosp. of Ioannina
🇬🇷Ioannina, Greece
Univ. Gen. Hosp. of Patras
🇬🇷Patras, Greece
Koranyi National Institute For Pulmonolgy
🇭🇺Budapest, Hungary
A. O. Universitaria Careggi
🇮🇹Firenze, Italy
Ospedale Colonnello D Avanzo
🇮🇹Foggia, Italy
Ospedale G.B. Morgagni
🇮🇹Forli', Italy
Azienda Ospedaliera San Martino
🇮🇹Genova, Italy
Ospedale Classificato San Giuseppe
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria di Padova
🇮🇹Padova, Italy
Pol. Universitario Tor Vergata
🇮🇹Roma, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
🇮🇹Roma, Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
🇮🇹Roma, Italy
Tosei General Hospital
🇯🇵Aichi, Seto, Japan
Chiba University Hospital
🇯🇵Chiba, Chiba, Japan
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
Nagasaki University Hospital
🇯🇵Nagasaki, Nagasaki, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
🇯🇵Osaka, Sakai, Japan
Hamamatsu University Hospital
🇯🇵Shizuoka, Hamamatsu, Japan
Tokushima University Hospital
🇯🇵Tokushima, Tokushima, Japan
Kyorin University Hospital
🇯🇵Tokyo, Mitaka, Japan
Toho University Omori Medical Center
🇯🇵Tokyo, Ota-ku, Japan
National Center for Global Health and Medicine
🇯🇵Tokyo, Shinjuku-ku, Japan
The Catholic University of Korea, Bucheon St.Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Sultan Idris Shah Serdang
🇲🇾Kajang, Malaysia
Institut Perubatan Respiratori
🇲🇾Kuala Lumpur, Malaysia
Sarawak General Hospital
🇲🇾Kuching, Sarawak, 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
University Clinical Hospital in Bialystok I
🇵🇱Bialystok, Poland
Alergopneuma Medical Center
🇵🇱Swidnik, Poland
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
🇵🇱Warsaw, Poland
Singapore General Hospital
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de Galdakao
🇪🇸Galdakao, Spain
Hospital de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Hospital Quirónsalud Madrid
🇪🇸Pozuelo de Alarcón, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Clínico de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Skånes universitetssjukhus, Lund
🇸🇪Lund, Sweden
CTC Clinical Trial Consultants AB
🇸🇪Uppsala, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital(Linkou)
🇨🇳TaoYuan, Taiwan
Chulalongkorn Hospital
🇹🇭Bangkok, Thailand
Srinagarind Hospital
🇹🇭Khon Kaen, Thailand
Ramathibodi Hospital
🇹🇭Ratchatewi, Thailand
Songklanagarind Hospital
🇹🇭Songkhla, Thailand
Castle Hill Hospital
🇬🇧Cottingham, United Kingdom
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