The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis

September 17, 2026 updated by: Boehringer Ingelheim

A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg Administered Once Daily for up to 76 Weeks in Patients With Bronchiectasis (The AIRTIVITY™ Study)

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).

The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months.

Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.

Study Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

1755

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Alberdi Sur, Argentina, X5003DCE
      • Bahía Blanca, Argentina
        • Recruiting
        • CEC- Centro de Especialidades Cardiovasculares
        • Contact:
      • CABA, Argentina, C1128AAF
      • CABA, Argentina, 1425
        • Recruiting
        • Centro de Investigacion Clinica Belgrano
        • Contact:
      • CABA, Argentina, C1428BNF
      • CABA, Argentina, 1118
      • CABA, Argentina, 1182
        • Recruiting
        • Fundacion NIBA Neurologia Infantil Buenos Aires
        • Contact:
      • Ciudad Autonoma Buenos Aires, Argentina, C1046AAQ
        • Recruiting
        • APRILLUS-Asistencia e Investigacion
        • Contact:
      • Mar del Plata, Argentina, 7600
        • Recruiting
        • Instituto Ave Pulmo - Fundacion Enfisema
        • Contact:
      • Quilmes, Argentina, B1878FNR
      • Rosario, Argentina, 2000
        • Recruiting
        • Instituto de Especialidades de la Salud Rosario
        • Contact:
      • Santa Fe, Argentina, 3000
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Active, not recruiting
        • Canberra Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Active, not recruiting
        • Royal Prince Alfred Hospital
      • North Ryde, New South Wales, Australia, 2109
        • Active, not recruiting
        • Macquarie University
      • Westmead, New South Wales, Australia, 2145
        • Active, not recruiting
        • Westmead Hospital
    • Queensland
      • Chelmer, Queensland, Australia, 4068
        • Active, not recruiting
        • Heart of Australia Research Institute
      • Chermside, Queensland, Australia, 4032
        • Active, not recruiting
        • The Prince Charles Hospital
      • Chermside, Queensland, Australia, 4032
        • Active, not recruiting
        • Lung Research Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Active, not recruiting
        • Greenslopes Private Hospital
      • South Brisbane, Queensland, Australia, 4101
      • South Brisbane, Queensland, Australia, 4101
        • Active, not recruiting
        • Mater Hospital Brisbane
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Completed
        • Eastern Health-Box Hill Hospital
      • Frankston, Victoria, Australia, 3199
        • Active, not recruiting
        • Peninsula Health
      • Melbourne, Victoria, Australia, 3004
        • Completed
        • Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Active, not recruiting
        • Institute for Respiratory Health
      • Spearwood, Western Australia, Australia, 6163
        • Active, not recruiting
        • Trialswest
      • Graz, Austria, 8036
      • Innsbruck, Austria, 6020
      • Brussels, Belgium, 1200
        • Active, not recruiting
        • Cliniques universitaires Saint-Luc
      • Ghent, Belgium, 9000
        • Active, not recruiting
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • Active, not recruiting
        • UZ Leuven
      • Sint-Niklaas, Belgium, 9100
        • Active, not recruiting
        • Vitaz - Campus Sint-Niklaas
      • Barra Mansa, Brazil, 27323240
        • Recruiting
        • Serviços Medicos Respirar Sul Fluminense
        • Contact:
      • Botucatu, Brazil, 18618-687
        • Recruiting
        • Faculdade de Medicina de Botucatu - UNESP
        • Contact:
      • Brasília, Brazil, 72145-450
        • Recruiting
        • Chronos Pesquisa Clinica
        • Contact:
      • Goiânia, Brazil, 74605-020
        • Recruiting
        • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
        • Contact:
      • Porto Alegre, Brazil, 90035-074
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
        • Contact:
      • São Bernardo do Campo, Brazil, 09750-420
        • Recruiting
        • Netspiro Clinica Medica Ltda - Respsono
        • Contact:
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • INCOR e Hospital das Clínicas da Universidade de São Paulo
        • Contact:
      • Pernik, Bulgaria, 2300
        • Active, not recruiting
        • MHAT Rahila Angelova AD
      • Plovdiv, Bulgaria, 4023
        • Active, not recruiting
        • DCC V Plovdiv St. Archbishop Luka EOOD
      • Rousse, Bulgaria, 7002
        • Active, not recruiting
        • SHATPPD "Dr. Dimitar Gramatikov"
      • Sofia, Bulgaria, 1680
        • Active, not recruiting
        • Diagnostics And Consultation Center Convex Ltd.
      • Sofia, Bulgaria, 1606
        • Active, not recruiting
        • Multiprofile Hospital MHATEM 'Pirogov', Sofia
      • Sofia, Bulgaria, 1756
        • Active, not recruiting
        • Medical Center "Pulmovision"
      • Veliko Tarnovo, Bulgaria, 5000
        • Active, not recruiting
        • Medical Center Tara
      • Vidin, Bulgaria, 3700
        • Active, not recruiting
        • Medical Center "Sveti Ivan Rilski"
      • Vratsa, Bulgaria, 3001
        • Active, not recruiting
        • Sbalpfz-Vratsa
      • Québec, Canada, G1V 4G5
        • Recruiting
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
        • Contact:
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • St. Paul's Hospital (Vancouver)
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3L 1Z5
        • Recruiting
        • Cardio 1 Medical Clinic
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Recruiting
        • QEII Health Sciences Centre
        • Contact:
    • Ontario
      • Burlington, Ontario, Canada, L7N 3V2
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre hospitalier de l'Université de Montréal (CHUM)
        • Contact:
      • Sherbrooke, Quebec, Canada, J1E 0N8
        • Recruiting
        • Diex Recherche (Sherbrooke Est)
        • Contact:
      • Trois-Rivières, Quebec, Canada, G9A 4P3
        • Recruiting
        • Diex Recherche (Trois-Rivieres)
        • Contact:
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Recruiting
        • Royal University Hospital (Saskatoon)
        • Contact:
      • Santiago, Chile, 7750000
        • Recruiting
        • Centro de Estudios Clinicos CEC
        • Contact:
      • Talca, Chile, 3465586
        • Recruiting
        • Centro de Investigacion del Maule
        • Contact:
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, China, 100045
        • Recruiting
        • Beijing Children's Hospital, Capital Medical University
        • Contact:
      • Changchun, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, China, 130000
        • Recruiting
        • The Second Hospital of Jilin University
        • Contact:
      • Changsha, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Chengdu, China, 610072
        • Recruiting
        • People's Hospital of Sichuan Province
        • Contact:
      • Guangzhou, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, China, 510000
        • Recruiting
        • First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guiyang, China, 550002
        • Recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
      • Hangzhou, China, 310013
      • Hangzhou, China, 310006
        • Recruiting
        • Hangzhou First People's Hospital
        • Contact:
      • Hangzhou, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Contact:
      • Hangzhou, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Contact:
      • Hefei, China, 230022
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
      • Huzhou, China, 313000
        • Recruiting
        • Huzhou Central Hospital
        • Contact:
      • Jiangmen, China, 529030
        • Recruiting
        • Jiangmen Central Hospital
        • Contact:
      • Nanchang, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, China, 330006
        • Recruiting
        • The Second Affiliated Hospital to Nanchang University
        • Contact:
      • Nanjing, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanjing, China, 210006
        • Recruiting
        • Nanjing First Hospital
        • Contact:
      • Nantong, China, 226001
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
      • Ningbo, China, 315000
        • Recruiting
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
      • Ningbo, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:
      • Pingxiang, China, 337000
        • Recruiting
        • Pingxiang People's Hospital
        • Contact:
      • Qingdao, China, 266011
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
      • Quanzhou, China, 362000
        • Recruiting
        • The Second Affiliated Hospital of Fujian Medical University
        • Contact:
      • Shanghai, China, 200065
        • Recruiting
        • Tongji Hospital, Tongji University
        • Contact:
      • Shanghai, China, 200040
        • Recruiting
        • Huadong Hospital affiliated to Fudan University
        • Contact:
      • Shanghai, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
      • Shanghai, China, 200240
        • Recruiting
        • Shanghai Fifth People's Hospital affiliated to Fudan University
        • Contact:
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Contact:
      • Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital Affiliated to Fudan University
        • Contact:
      • Shanghai, China, 201700
        • Recruiting
        • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
        • Contact:
      • Shanghai, China, 201102
        • Recruiting
        • The Children's Hospital of Fudan University
        • Contact:
      • Shenzhen, China, 518020
        • Recruiting
        • Shenzhen People's Hospital
        • Contact:
      • Suzhou, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
      • Tianjin, China, 30052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Wenzhou, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Wenzhou, China, 325006
        • Recruiting
        • Wenzhou People's Hospital
        • Contact:
      • Wuhan, China, 430056
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
        • Contact:
      • Wuxi, China, 214043
        • Recruiting
        • Wuxi People's Hospital
        • Contact:
      • Xi'an, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
      • Xuzhou, China, 221006
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical College
        • Contact:
      • Yangzhou, China, 225001
        • Recruiting
        • Northern Jiangsu People's Hospital
        • Contact:
      • Yixing, China, 214258
        • Recruiting
        • Yixing People'S Hospital
        • Contact:
      • Zagreb, Croatia, 10000
        • Completed
        • Clinical Hospital Centre Zagreb
      • Zagreb, Croatia, 10000
        • Active, not recruiting
        • Clinical Hospital Centar Sestre Milosrdnice
      • Jindřichův Hradec, Czechia, 377 01
        • Active, not recruiting
        • MediTrial s.r.o.
      • Prague, Czechia, 15000
        • Completed
        • University Hospital Motol
      • Prague, Czechia, 19000
        • Active, not recruiting
        • The First Pulmonary Private Practice
      • Aalborg, Denmark, 9000
        • Active, not recruiting
        • Aalborg Sygehus Syd
      • Aarhus N, Denmark, 8200
        • Active, not recruiting
        • Aarhus University Hospital
      • Hvidovre, Denmark, 2650
        • Active, not recruiting
        • Hvidovre Hospital
      • København Ø, Denmark, 2100
        • Active, not recruiting
        • Copenhagen University Hospital, Rigshospitalet
      • Vejle, Denmark, 7100
        • Active, not recruiting
        • Vejle University Hospital
      • Helsinki, Finland, 00290 HUS
        • Active, not recruiting
        • Helsinki University Hospital
      • Oulu, Finland, 90220
        • Active, not recruiting
        • Oulun yliopistollinen keskussairaala
      • Tampere, Finland, 33520
        • Active, not recruiting
        • Tampere University Hospital
      • Turku, Finland, 20520
        • Active, not recruiting
        • Turku University Hospital / TYKS
      • Amiens, France, 80054
        • Completed
        • CHU Amiens-Picardie
      • Créteil, France, 94000
      • Lille, France, 59037
      • Lyon, France, 69004
        • Recruiting
        • Hôpital de la Croix-Rousse
        • Contact:
      • Montpellier, France, 34295
        • Recruiting
        • HOP Arnaud de Villeneuve
        • Contact:
      • Nice, France, 06001
      • Paris, France, 75014
      • Pessac, France, 33604
      • Rennes, France, 35000
      • Saint-Herblain, France, 44800
      • Tououse, France, 31059
        • Recruiting
        • Hôpital Larrey - CHU de Toulouse
        • Contact:
      • Aachen, Germany, 52074
      • Ahrensburg, Germany, 22926
        • Recruiting
        • Velocity Clinical Research Germany GmbH, Ahrensburg
        • Contact:
      • Bamberg, Germany, 96049
      • Berlin, Germany, 13353
      • Berlin, Germany, 10117
      • Berlin, Germany, 12351
      • Berlin, Germany, 13125
        • Completed
        • Evangelische Lungenklinik Berlin gGmbH
      • Bochum, Germany, 44791
      • Bonn, Germany, 53127
      • Cologne, Germany, 50937
      • Cologne, Germany, 50678
      • Donaustauf, Germany, 93093
      • Dortmund, Germany, 44145
      • Dresden, Germany, 01307
      • Essen, Germany, 45239
        • Recruiting
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
        • Contact:
      • Frankfurt, Germany, 60590
      • Frankfurt, Germany, 60596
      • Freiburg im Breisgau, Germany, 79106
      • Gauting, Germany, 82131
      • Halle, Germany, 06120
        • Recruiting
        • Martin-Luther-Universität Halle-Wittenberg
        • Contact:
      • Halle, Germany, 06120
        • Recruiting
        • Krankenhaus Martha-Maria Halle-Dölau gGmbH
        • Contact:
      • Hanover, Germany, 30625
      • Heidelberg, Germany, 69126
        • Recruiting
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
        • Contact:
      • Immenhausen, Germany, 34376
      • Jena, Germany, 07747
      • Kiel, Germany, 24105
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel
        • Contact:
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Contact:
      • München, Germany, 80336
      • München, Germany, 81241
        • Recruiting
        • Pneumologisches Studienzentrum München-West
        • Contact:
      • Münster, Germany, 48149
      • Potsdam, Germany, 14467
        • Recruiting
        • Klinikum Ernst von Bergmann GmbH, CF-Zentrum Potsdam
        • Contact:
      • Stralstund, Germany, 18435
      • Wiesbaden, Germany, 65183
      • Hong Kong, Hong Kong, 999077
      • Hong Kong, Hong Kong, 999077
        • Recruiting
        • Prince of Wales Hospital-Hong Kong-20715
        • Contact:
      • Budapest, Hungary, 1028
      • Hatvan, Hungary, H-3000
        • Active, not recruiting
        • BKS Research Ltd
      • Pécs, Hungary, 7635
        • Active, not recruiting
        • Da Vinci Private Clinic
      • Lucknow, India, 226006
        • Completed
        • Midland Healthcare & Research Center
      • Cork, Ireland, T12 DC4A
        • Active, not recruiting
        • Cork University Hospital
      • Dublin, Ireland, D15 X40D
        • Active, not recruiting
        • Connolly Hospital Blanchardstown
      • Dublin, Ireland, D04 T6F4
        • Completed
        • St. Vincent'S University Hospital
      • Haifa, Israel, 3436212
        • Active, not recruiting
        • Lady Davis Carmel Medical Center
      • Jerusalem, Israel, 9112001
        • Active, not recruiting
        • Hadassah Medical Center, Ein-Karem
      • Jerusalem, Israel, 9765422
        • Active, not recruiting
        • Hadassah Medical Center, Ein-Karem
      • Petah Tikva, Israel, 4941492
        • Active, not recruiting
        • Rabin Medical Center Beilinson
      • Tel Aviv, Israel, 6423906
        • Active, not recruiting
        • Sourasky Medical Center
      • Ancona, Italy, 60126
        • Recruiting
        • Azienda Ospedaliero Universitaria Delle Marche
        • Contact:
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico S. Orsola-Malpighi
        • Contact:
      • Catania, Italy, 95121
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
        • Contact:
      • Genova, Italy, 16132
        • Recruiting
        • Azienda Ospedaliera San Martino
        • Contact:
      • Genova, Italy, 16147
      • Messina, Italy, 98124
        • Not yet recruiting
        • A.O.U.Policlinico G.Martino
        • Contact:
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Contact:
      • Monza (MB), Italy, 20900
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Di Monza
        • Contact:
      • Naples, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera dei Colli
        • Contact:
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedaliera Universitaria di Padova
        • Contact:
      • Palermo, Italy, 90127
        • Recruiting
        • Policlinico "Paolo Giaccone"
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico S. Matteo
        • Contact:
      • Roma, Italy, 00165
        • Not yet recruiting
        • Ospedale Pediatrico Bambino Gesu
        • Contact:
      • Roma, Italy, 00168
        • Completed
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Rozzano (MI), Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
        • Contact:
      • Verona, Italy, 37126
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Contact:
      • Aichi, Nagoya, Japan, 466-8560
        • Recruiting
        • Nagoya University Hospital
        • Contact:
      • Aomori, Hirosaki, Japan, 036-8563
        • Recruiting
        • Hirosaki University Hospital
        • Contact:
      • Chiba, Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital
        • Contact:
      • Chiba, Kamogawa, Japan, 296-0041
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Recruiting
        • Fukuoka University Hospital
        • Contact:
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
      • Fukuoka, Fukuoka, Japan, 813-0017
        • Recruiting
        • Fukuoka Children's Hospital
        • Contact:
      • Fukuoka, Iizuka, Japan, 820-8505
        • Recruiting
        • Aso Co.,Ltd Iizuka Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
      • Hyogo, Himeji, Japan, 670-0849
        • Recruiting
        • Terada Clinic, Respiratory Medicine & General practice
        • Contact:
      • Ibaraki, Tsukuba, Japan, 305-8576
        • Recruiting
        • University of Tsukuba Hospital
        • Contact:
      • Kagoshima, Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University Hospital
        • Contact:
      • Kanagawa, Yokohama, Japan, 236-0051
        • Recruiting
        • Kanagawa Cardiovascular and Respiratory Center
        • Contact:
      • Kyoto, Joyo, Japan, 610-0113
      • Kyoto, Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital
        • Contact:
      • Mie, Matsusaka, Japan, 515-8544
        • Recruiting
        • Matsusaka City Hospital
        • Contact:
      • Miyagi, Sendai, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
        • Contact:
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Recruiting
        • Nagasaki University Hospital
        • Contact:
      • Niigata, Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical and Dental Hospital
        • Contact:
      • Oita, Yufu, Japan, 879-5593
        • Recruiting
        • Oita University Hospital
        • Contact:
      • Okayama, Kurashiki, Japan, 710-8602
        • Recruiting
        • Kurashiki Central Hospital
        • Contact:
      • Osaka, Sakai, Japan, 591-8555
        • Recruiting
        • National Hospital Organization Kinki-Chuo Chest Medical Center
        • Contact:
      • Osaka, Toyonaka, Japan, 560-8552
        • Recruiting
        • Osaka Toneyama Medical Center
        • Contact:
      • Saga, Saga, Japan, 849-8501
        • Recruiting
        • Saga University Hospital
        • Contact:
      • Saitama, Kumagaya, Japan, 360-0197
        • Recruiting
        • Saitama Cardiovascular and Respiratory Center
        • Contact:
      • Shiga, Otsu, Japan, 520-2192
        • Recruiting
        • Shiga University of Medical Science Hospital
        • Contact:
      • Shimane, Matsue, Japan, 690-8556
      • Shizuoka, Hamamatsu, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital
        • Contact:
      • Shizuoka, Hamamatsu, Japan, 434-8511
      • Tokushima, Tokushima, Japan, 770-8503
        • Recruiting
        • Tokushima University Hospital
        • Contact:
      • Tokyo, Bunkyo-ku, Japan, 113-8519
        • Recruiting
        • Institute of Science Tokyo Hospital
        • Contact:
      • Tokyo, Itabashi-ku, Japan, 173-8610
        • Recruiting
        • Nihon University Itabashi Hospital
        • Contact:
      • Tokyo, Kiyose, Japan, 204-8522
      • Tokyo, Minato-ku, Japan, 105-8470
      • Tokyo, Setagaya-ku, Japan, 157-8535
        • Recruiting
        • National Center for Child Health and Development
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 160-8582
        • Recruiting
        • Keio University Hospital
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 162-8666
        • Recruiting
        • Tokyo Women's Medical University Hospital
        • Contact:
      • Yamaguchi, Ube, Japan, 755-8505
        • Recruiting
        • Yamaguchi University Hospital
        • Contact:
      • Astana, Kazakhstan, 010000
        • Active, not recruiting
        • Multidisciplinary City Hospital №1 of the Akimat of Astana
      • Karaganda, Kazakhstan, 100019
        • Active, not recruiting
        • Regional Clinical Hospital of the Health Department of the Karaganda Region
      • Daugavpils, Latvia, 5410
        • Active, not recruiting
        • Veselibas centru apvieniba AS
      • Daugavpils, Latvia, 5417
        • Completed
        • Daugavpils regionala slimnica SIA
      • Jūrmala, Latvia, 2015
        • Completed
        • VCA Dubultu Medical center
      • Riga, Latvia, LV-1002
        • Active, not recruiting
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia, 1001
        • Completed
        • Rigas 1. slimnica SIA
      • Riga, Latvia, 1011
        • Active, not recruiting
        • Mediciniskas pecdiploma izglitibas instituts SIA
      • Upeslejas, Latvia, 2118
        • Active, not recruiting
        • Rigas Austrumu kliniska universitates slimnica SIA
      • Kaunas, Lithuania, 50161
        • Active, not recruiting
        • Hospital of Lithuanian University of Health Sciences Kauno klinikos
      • Klaipėda, Lithuania, 92231
        • Active, not recruiting
        • Republic Klaipeda Hospital
      • Vilnius, Lithuania, 08406
        • Active, not recruiting
        • Vilnius University Hospital, Santariskiu
      • Alor Setar, Kedah, Malaysia, 05460
        • Active, not recruiting
        • Hospital Sultanah Bahiyah
      • Kajang, Malaysia, 43000
        • Active, not recruiting
        • Hospital Sultan Idris Shah Serdang
      • Kelantan, Malaysia, 15586
        • Active, not recruiting
        • Hospital Raja Perempuan Zainab II
      • Kuala Lumpur, Malaysia, 59100
        • Active, not recruiting
        • University Malaya Medical Centre
      • Kuala Lumpur, Malaysia, 50586
        • Active, not recruiting
        • Institut Perubatan Respiratori
      • Kuching, Malaysia, 93586
        • Active, not recruiting
        • Sarawak General Hospital
      • Chihuahua City, Mexico, 31203
        • Recruiting
        • Centro de Investigacion Integral MEDIVEST S.C
        • Contact:
      • Chihuahua City, Mexico, 31203
        • Completed
        • Mediadvance Clinical S.A.P.I de C.V.
      • León, Mexico, 37160
        • Recruiting
        • Centro de Investigacion Farmacologica del Bajío, S.C.
        • Contact:
      • Mexico City, Mexico, 03650
        • Recruiting
        • Soluciones terapeuticas medico quirurgicas S de RL de CV
        • Contact:
      • Oaxaca City, Mexico, 68000
        • Completed
        • Oaxaca Site Management Organization, S.C.
      • Pachuca, Mexico, 42070
        • Completed
        • Asociación Mexicana para la Investigacion Clínica, A.C(AMIC)
      • Tlalnepantla, Mexico, 54055
        • Completed
        • Clinical Research Institute S.C.
      • Veracruz de Ignacio de La Llave, Mexico, 91900
        • Completed
        • Arke SMO S.A. de C.V.
      • Alkmaar, Netherlands, 1815 JD
        • Active, not recruiting
        • Noordwest Ziekenhuisgroep
      • Amsterdam, Netherlands, 1081HV
        • Active, not recruiting
        • Amsterdam UMC locatie Vumc
      • Rotterdam, Netherlands, 3015 GD
        • Active, not recruiting
        • Erasmus Medisch Centrum-ROTTERDAM-50697
      • The Hague, Netherlands, 2545 AA
        • Active, not recruiting
        • Haga Ziekenhuis
      • Utrecht, Netherlands
        • Active, not recruiting
        • UMC Utrecht
      • Zutphen, Netherlands, 7207 AE
        • Active, not recruiting
        • Gelre Ziekenhuis Zutphen
      • Christchurch, New Zealand, 8011
        • Active, not recruiting
        • Christchurch Hospital
      • Papatoetoe, New Zealand, 2025
        • Active, not recruiting
        • Middlemore Clinical Trials
      • Rotorua, New Zealand, 3010
        • Active, not recruiting
        • Momentum clinical Research Rotorua
    • Auckland
      • Greenlane East, Auckland, New Zealand, 1051
        • Active, not recruiting
        • NZ Respiratory and Sleep Institute
    • Dunedin
      • Central Dunedin, Dunedin, New Zealand, 9016
        • Active, not recruiting
        • Momentum Clinical Research Dunedin
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3240
        • Active, not recruiting
        • Waikato Hospital
    • Wellington Region
      • Mount Cook, Wellington Region, New Zealand, 6021
        • Active, not recruiting
        • Momentum Clinical Research
      • Iloilo City, Philippines, 5000
        • Active, not recruiting
        • West Visayas State University Medical Center
      • Iloilo City, Philippines, 5000
        • Active, not recruiting
        • Iloilo Doctors Hospital
      • Mandaluyong, Philippines, 1552
        • Active, not recruiting
        • Health Cube Medical Clinics
      • Quezon City, Philippines, 1109
        • Active, not recruiting
        • Quirino Memorial Medical Center
      • Taft, Manila, Philippines, 1000
        • Active, not recruiting
        • Philippine General Hospital
      • Bialystok, Poland, 15044
        • Active, not recruiting
        • Respiratory Medicine Centre, private prac., Bialystok
      • Chorzów, Poland, 41-500
        • Active, not recruiting
        • M2M Med. Badania Sp. z o.o.
      • Piaseczno, Poland, 05500
        • Active, not recruiting
        • Screenmed Sp. z o.o.
      • Rzeszów, Poland, 35205
        • Active, not recruiting
        • EMED, Center of Medical Services,Private Prac,Rzeszow
      • Warsaw, Poland, 01-456
        • Active, not recruiting
        • Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski
      • Wołomin, Poland, 05200
        • Completed
        • Medical Center K2J2
      • Aveiro, Portugal, 3814-501
        • Active, not recruiting
        • ULS da Região de Aveiro
      • Braga, Portugal, 4710-243
        • Active, not recruiting
        • ULS de Braga, E.P.E
      • Coimbra, Portugal, 3004-561
        • Active, not recruiting
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
      • Guimarães, Portugal, 4835-045
        • Active, not recruiting
        • ULS do Alto Ave
      • Leiria, Portugal, 2410-197
        • Active, not recruiting
        • ULS da Região de Leiria, E.P.E.
      • Lisbon, Portugal, 1649-035
        • Active, not recruiting
        • ULS de Santa Maria, E.P.E
      • Porto, Portugal, 4202-451
        • Active, not recruiting
        • Centro Hospitalar Universitário São João,EPE
      • Caguas, Puerto Rico, 00726
      • San Juan, Puerto Rico, 00921
      • San Juan, Puerto Rico, 00927
        • Completed
        • Puerto Rico Consortium for Clinical Investigation
      • Bucharest, Romania, 050159
        • Active, not recruiting
        • Institutul De Pneumoftiziologie Marius Nasta
      • Cluj-Napoca, Romania, 400001
        • Active, not recruiting
        • SC Medlife S.A
      • Cluj-Napoca, Romania, 400003
        • Active, not recruiting
        • Spitalul Clinic De Pneumoftiziologie Leon Daniello
      • Timișoara, Romania, 300310
        • Active, not recruiting
        • Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
      • Singapore, Singapore, 169608
        • Active, not recruiting
        • Singapore General Hospital
      • Singapore, Singapore, 529889
        • Active, not recruiting
        • Changi General Hospital
      • Singapore, Singapore, 308433
        • Active, not recruiting
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 119074
        • Active, not recruiting
        • National University Hospital-Singapore-42005
      • Martin, Slovakia, 036 01
        • Active, not recruiting
        • Univerzitna Nemocnica Martin
      • Spišská Nová Ves, Slovakia, 05201
        • Active, not recruiting
        • Plucna ambulancia Hrebenar s.r.o.
      • Bloemfontein, South Africa, 9301
      • Cape Town, South Africa, 7764
      • Durban, South Africa, 4001
        • Completed
        • Addington Hospital
      • Mount Edgecombe, South Africa, 4301
      • Springfield, South Africa, 4091
        • Recruiting
        • CAPRISA Offices on the King DinuZulu Hospital Complex
        • Contact:
      • Anyang, South Korea, 14068
        • Active, not recruiting
        • Hallym University Sacred Heart Hospital
      • Chungju, South Korea, 28644
        • Active, not recruiting
        • Chungbuk National University Hospital
      • Daegu, South Korea, 42415
        • Active, not recruiting
        • Yeongnam University Hospital
      • Dong-gu Ulsan, South Korea, 44033
        • Active, not recruiting
        • Ulsan University Hospital
      • Incheon, South Korea, 21431
        • Active, not recruiting
        • The Catholic University of Korea, Incheon St. Mary's Hospital
      • Seoul, South Korea, 06351
        • Active, not recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 08308
        • Active, not recruiting
        • Korea University Guro Hospital
      • Seoul, South Korea, 04763
        • Recruiting
        • Hanyang University Medical Center
        • Contact:
      • Seoul, South Korea, 05505
        • Active, not recruiting
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Active, not recruiting
        • Severance Hospital
      • Seoul, South Korea, 07441
        • Recruiting
        • Hallym University Kangnam Sacred Heart Hospital
        • Contact:
      • Seoul, South Korea, 05030
        • Active, not recruiting
        • Konkuk University Medical Center
      • Seoul, South Korea, 06591
        • Active, not recruiting
        • The Catholic University of Korea, Seoul St.Mary's Hospital
      • Seoul, South Korea, 07071
        • Active, not recruiting
        • SMG-SNU Boramae Medical Center
      • Seoul, South Korea, 22711
        • Active, not recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Seoul, South Korea, 54907
        • Active, not recruiting
        • Jeonbuk National University Hospital
      • Seoul, South Korea, 05355
        • Completed
        • Kangdong Sacred Heart Hospital
      • Wŏnju, South Korea, 26426
        • Active, not recruiting
        • Yonsei University Wonju Severance Christian Hospital
      • A Coruña, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
      • Badalona, Spain, 08916
        • Recruiting
        • Hospital Germans Trías i Pujol
        • Contact:
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
      • El Palmar, Spain, 30120
        • Recruiting
        • Hospital Universitario Virgen de la Arrixaca
        • Contact:
      • Girona, Spain, 17007
        • Recruiting
        • Hospital Universitari de Girona Doctor Josep Trueta
        • Contact:
      • Huelva, Spain, 21080
      • Jerez de la Frontera, Spain, 11407
        • Recruiting
        • Hospital Jerez de la Frontera
        • Contact:
      • L'Hospitalet de Llobregat, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
      • Mérida, Spain, 06800
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Central de Asturias
        • Contact:
      • Palma de Mallorca, Spain, 07120
      • Pamplona, Spain, 31008
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
      • Pozuelo de Alarcón, Spain, 28223
        • Recruiting
        • Hospital Quirónsalud Madrid
        • Contact:
      • Puerto Real, Spain, 11510
        • Completed
        • Hospital Universitario Puerto Real
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Complexo Hospitalario Universitario De Santiago
        • Contact:
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Virgen Del Rocio
        • Contact:
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen De La Macarena
        • Contact:
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
      • Stockholm, Sweden, SE-171 64
        • Active, not recruiting
        • Karolinska University Hospital
      • Uppsala, Sweden, 752 37
        • Active, not recruiting
        • CTC Clinical Trial Consultants AB
      • Örebro, Sweden, 703 82
        • Active, not recruiting
        • Universitetssjukhuset, Örebro
      • Basel, Switzerland, 4031
        • Active, not recruiting
        • Universitätsspital Basel
      • Lausanne, Switzerland
        • Recruiting
        • University Hospital of Lausanne
        • Contact:
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
      • Taipei, Taiwan, 10048
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital, Linkou
        • Contact:
      • Yunlin County, Taiwan, 632
        • Recruiting
        • National Taiwan University Hospital Yun-Lin Branch
        • Contact:
      • Bangkok, Thailand, 10400
        • Active, not recruiting
        • Ramathibodi Hospital
      • Bangkok, Thailand, 10700
        • Active, not recruiting
        • Siriraj Hospital
      • Khon Kaen, Thailand, 40002
        • Active, not recruiting
        • Srinagarind Hospital
      • Songkhla, Thailand, 90110
        • Recruiting
        • Songklanagarind Hospital
        • Contact:
      • Thailand, Thailand, 10330
        • Recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:
      • Ankara, Turkey (Türkiye), 06620
        • Completed
        • Ankara University Medical Faculty
      • Belfast, United Kingdom, BT9 7AB
        • Completed
        • Belfast City Hospital
      • Birmingham, United Kingdom, B9 5SS
      • Blackpool, United Kingdom, FY3 8NR
      • Bradford, United Kingdom, BD9 6RJ
      • Bristol, United Kingdom, BS8 2RA
      • Cambridge, United Kingdom, CB2 0AY
      • Cardiff, United Kingdom, CF64 2XX
      • Dundee, Scotland, United Kingdom, DD1 9SY
      • East Kilbride, United Kingdom, G75 8RG
        • Completed
        • University Hospital Hairmyres
      • Edinburgh, United Kingdom, EH4 2XU
      • Edinburgh, United Kingdom, EH16 4TJ
      • Edinburgh, United Kingdom, EH16 4SA
      • High Heaton, United Kingdom, NE7 7DN
      • Lancaster, United Kingdom, LA1 4RP
      • Leeds, United Kingdom, LS9 7TF
      • Liverpool, United Kingdom, L14 3PE
      • London, United Kingdom, SW3 6NP
      • London, United Kingdom, SE5 9RS
      • Portadown, United Kingdom, BT63 5QQ
      • Sheffield, United Kingdom, S5 7AU
      • Southampton, United Kingdom, SO16 6YD
      • Stoke-on-Trent, United Kingdom, ST4 6QG
      • Torquay, United Kingdom, TQ2 7AA
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Not yet recruiting
        • Dignity Health, St. Joseph's Hospital and Medical Center
        • Contact:
      • Tucson, Arizona, United States, 85724
        • Active, not recruiting
        • University of Arizona
    • California
      • Newport Beach, California, United States, 92663
        • Active, not recruiting
        • Newport Native MD, Inc
      • Redding, California, United States, 96001
        • Active, not recruiting
        • Paradigm Clinical Research - Redding
      • Sacramento, California, United States, 95817
        • Active, not recruiting
        • University of California Davis
      • San Francisco, California, United States, 94143
        • Active, not recruiting
        • University of California San Francisco
      • Ventura, California, United States, 93003
        • Completed
        • Ventura County Medical Center
    • Colorado
      • Denver, Colorado, United States, 80206
        • Active, not recruiting
        • National Jewish Health
    • Connecticut
      • North Haven, Connecticut, United States, 06473
        • Active, not recruiting
        • Yale University School Of Medicine
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Active, not recruiting
        • Georgetown University
    • Florida
      • Altamonte Springs, Florida, United States, 32701
      • Brandon, Florida, United States, 33511
        • Active, not recruiting
        • Meris Clinical Research-Brandon-69466
      • Clearwater, Florida, United States, 33765
        • Completed
        • St. Francis Medical Institute
      • Gainesville, Florida, United States, 32608
        • Completed
        • North Florida/South Georgia Veterans Health System
      • Jacksonville, Florida, United States, 32209
        • Completed
        • University of Florida College of Medicine
      • Jacksonville, Florida, United States, 32224
        • Active, not recruiting
        • Mayo Clinic - Florida
      • Miami, Florida, United States, 33136
        • Active, not recruiting
        • University of Miami
      • Naples, Florida, United States, 34102
        • Active, not recruiting
        • Essence MD Research
      • Tampa, Florida, United States, 33614
        • Active, not recruiting
        • Vantage Clinical Trials - Tampa
      • Weston, Florida, United States, 33331
        • Active, not recruiting
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Augusta, Georgia, United States, 30912
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Completed
        • Indiana University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Completed
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Active, not recruiting
        • University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
      • Towson, Maryland, United States, 21286
        • Completed
        • University of Maryland St. Joseph Medical Group Pulmonary Care and Sleep Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Active, not recruiting
        • Massachusetts General Hospital
      • Worcester, Massachusetts, United States, 01655
        • Active, not recruiting
        • UMass Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Active, not recruiting
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Active, not recruiting
        • Mayo Clinic, Rochester
      • Saint Paul, Minnesota, United States, 55130
        • Active, not recruiting
        • HealthPartners Specialty Center 401 Building
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Active, not recruiting
        • University of Mississippi Medical Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Completed
        • The Lung Research Center, LLC
      • St Louis, Missouri, United States, 63110
        • Active, not recruiting
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63110
        • Completed
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68198-1230
        • Active, not recruiting
        • University of Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • New York
      • Hawthorne, New York, United States, 10532
      • New Hyde Park, New York, United States, 11040
        • Active, not recruiting
        • Northwell Health
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • Active, not recruiting
        • Columbia University Medical Center-New York Presbyterian Hospital
      • New York, New York, United States, 10016
        • Completed
        • New York University Langone Medical Center
      • New York, New York, United States, 10065
        • Completed
        • NewYork-Presbyterian/Weill Cornell Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Completed
        • The University of North Carolina at Chapel Hill
      • Huntersville, North Carolina, United States, 28078
        • Active, not recruiting
        • Stern Research Partners, LLC
      • Pinehurst, North Carolina, United States, 28374
        • Active, not recruiting
        • Pinehurst Medical Clinic, Inc. - East
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cincinnati, Ohio, United States, 45219
        • Active, not recruiting
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • Active, not recruiting
        • University Hospitals Cleveland Medical Center
      • Toledo, Ohio, United States, 43606
        • Not yet recruiting
        • ProMedica Physicians Pulmonary and Sleep Medicine - Toledo
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Active, not recruiting
        • Clinical Research Associates of Central PA
      • Philadelphia, Pennsylvania, United States, 19104
        • Active, not recruiting
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Active, not recruiting
        • Jefferson Health Honickman Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Completed
        • Medical University of South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Active, not recruiting
        • Clinical Research of Rock Hill
    • Texas
      • Cypress, Texas, United States, 77429
        • Active, not recruiting
        • Horizon Clinical Research Group
      • Dallas, Texas, United States, 75390
        • Active, not recruiting
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Active, not recruiting
        • Baylor University Medical Center
      • El Paso, Texas, United States, 79902
        • Active, not recruiting
        • El Paso Pulmonary Association
      • Galveston, Texas, United States, 77555
        • Active, not recruiting
        • University of Texas Medical Branch at Galveston
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • Baylor College of Medicine
      • McKinney, Texas, United States, 75069
        • Active, not recruiting
        • Metroplex Pulmonary & Sleep Center
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78258
        • Completed
        • Element Research Group
      • Tyler, Texas, United States, 75708
        • Active, not recruiting
        • University of Texas Health Science Center at Tyler
    • Utah
      • Murray, Utah, United States, 84107
        • Active, not recruiting
        • Intermountain Healthcare
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Active, not recruiting
        • University of Vermont
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Active, not recruiting
        • Inova Fairfax Medical Campus
      • Richmond, Virginia, United States, 23219
        • Active, not recruiting
        • Virginia Commonwealth University Health Systems
    • Washington
      • Seattle, Washington, United States, 98195
        • Active, not recruiting
        • University of Washington
      • Spokane, Washington, United States, 99204
        • Active, not recruiting
        • Providence Medical Research Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Active, not recruiting
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Active, not recruiting
        • Froedtert and The Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the participant information.
  • Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.
  • Age of participants when signing the informed consent/assent ≥12 years.

    -- Adolescents need to weigh at least 35 kg at Visit 1.

  • Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist.

Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.

  • Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.
  • History of documented pulmonary exacerbations (assessed and recorded by the investigator) requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:

    • at least 2 exacerbations, or
    • at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of >40 at screening Visit 1 (adults only)
    • at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.

Exclusion criteria:

  • Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
  • Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
  • Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
  • Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.
  • Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.
  • Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.
  • Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.
  • Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
  • estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) <30 mL/min at Visit 1.
  • Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo arm
Placebo matching BI 1291583
Experimental: Treatment arm
BI 1291583
Other Names:
  • Verducatib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76
Time Frame: up to 76 weeks
up to 76 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change from baseline in post-bronchodilator Forced Expiratory Volume in the first second (FEV1) %pred at Week 52
Time Frame: at baseline, at week 52
at baseline, at week 52
Absolute change from baseline in post-bronchodilator Forced Vital Capacity (FVC) %pred at Week 52
Time Frame: at baseline, at week 52
at baseline, at week 52
Time to first adjudicated pulmonary exacerbation up to Week 76
Time Frame: up to 76 weeks
up to 76 weeks
Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) respiratory symptoms domain score at Week 52 (participants ≥ 16 years)
Time Frame: at baseline, at week 52

The QOL-B is a patient reported outcome (PRO) measure assessing symptoms, functioning and health-related quality of life of patients with bronchiectasis. It consists of 37 items covering the following domains: respiratory symptoms, physical functioning, vitality, role functioning, health perception, emotional functioning, social functioning, and treatment burden.

All items are rated on a 4-point response scale ranging from 'a lot' to 'not at all' with the recall period 'the previous week'. Domain scores are generated ranging from 0 to 100, with higher scores indicating less symptom burden, better functioning, and higher health-related quality of life respectively.

at baseline, at week 52
Annualised rate of severe adjudicated pulmonary exacerbations up to Week 76
Time Frame: up to 76 weeks
up to 76 weeks
Time to first adjudicated severe pulmonary exacerbation up to Week 76
Time Frame: up to 76 weeks
up to 76 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2025

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

December 20, 2027

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 12, 2025

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 17, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1397-0014
  • 2024-518589-29-00 (Registry Identifier: EU CTIS)
  • U1111-1317-2315 (Registry Identifier: WHO - International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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