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NCT06872892PHASE3Recruiting

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

Boehringer Ingelheim

Start Date

6/9/2025

Completion Date

10/12/2028

Summary

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.

Eligibility Criteria

Age Range: 12 years to No maximum

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.

Interventions

DRUG

BI 1291583

DRUG

Placebo matching BI 1291583

Interested in This Trial?

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Conditions

Bronchiectasis

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Dignity Health, St. Joseph's Hospital and Medical Center

Phoenix, Arizona 85013

United States

University of Arizona

Tucson, Arizona 85724

United States

Newport Native MD, Inc

Newport Beach, California 92663

United States

Paradigm Clinical Research - Redding

Redding, California 96001

United States

University of California Davis

Sacramento, California 95817

United States

University of California San Francisco

San Francisco, California 94143

United States

Ventura County Medical Center

Ventura, California 93003

United States

National Jewish Health

Denver, Colorado 80206

United States

Yale University School of Medicine

North Haven, Connecticut 06473

United States

Georgetown University

Washington D.C., District of Columbia 20007

United States

Central Florida Pulmonary Group

Altamonte Springs, Florida 32701

United States

Meris Clinical Research-Brandon-69466

Brandon, Florida 33511

United States

St. Francis Medical Institute

Clearwater, Florida 33765

United States

North Florida/South Georgia Veterans Health System

Gainesville, Florida 32608

United States

University of Florida College of Medicine

Jacksonville, Florida 32209

United States

Mayo Clinic - Florida

Jacksonville, Florida 32224

United States

University of Miami

Miami, Florida 33136

United States

Essence MD Research

Naples, Florida 34102

United States

Vantage Clinical Trials - Tampa

Tampa, Florida 33614

United States

Cleveland Clinic Florida

Weston, Florida 33331

United States

Emory University

Atlanta, Georgia 30342

United States

Augusta University

Augusta, Georgia 30912

United States

Northwestern University

Chicago, Illinois 60611

United States

Indiana University

Indianapolis, Indiana 46202

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

University of Maryland St. Joseph Medical Group Pulmonary Care and Sleep Medicine

Towson, Maryland 21286

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

UMASS Memorial Medical Center

Worcester, Massachusetts 01655

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Mayo Clinic, Rochester

Rochester, Minnesota 55902

United States

Health Partners Specialty

Saint Paul, Minnesota 55130

United States

University Of Mississippi Medical Center

Jackson, Mississippi 39216

United States

The Lung Research Center, LLC

Chesterfield, Missouri 63017

United States

SSM Health Cardinal Glennon Children's Hospital

St Louis, Missouri 63104

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198-1230

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire 03766

United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey 08901

United States

New York Medical College - Hawthorne

Hawthorne, New York 10532

United States

Northwell Health

New Hyde Park, New York 11040

United States

New York University Langone Medical Center

New York, New York 10016

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Columbia University Medical Center-New York Presbyterian Hospital

New York, New York 10032

United States

NewYork-Presbyterian/Weill Cornell Medical Center

New York, New York 10065

United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27514

United States

Stern Research Partners, LLC

Huntersville, North Carolina 28078

United States

Pinehurst Medical Clinic, Inc. - East

Pinehurst, North Carolina 28374

United States

Akron Children's Hospital

Akron, Ohio 44308

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

ProMedica Physicians Pulmonary and Sleep Medicine - Toledo

Toledo, Ohio 43606

United States

Oregon Health and Sciences University

Portland, Oregon 97239

United States

Clinical Research Associates of Central PA

DuBois, Pennsylvania 15801

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Jefferson Health Honickman Center

Philadelphia, Pennsylvania 19107

United States

Clinical Research of Rock Hill

Rock Hill, South Carolina 29732

United States

Horizon Clinical Research Group

Cypress, Texas 77429

United States

Baylor University Medical Center

Dallas, Texas 75246

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

El Paso Pulmonary Association

El Paso, Texas 79902

United States

University of Texas Medical Branch at Galveston

Galveston, Texas 77555

United States

Baylor College of Medicine

Houston, Texas 77030

United States

Metroplex Pulmonary & Sleep Center

McKinney, Texas 75069

United States

Methodist Heart and Lung Institute

San Antonio, Texas 78229

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas 78229

United States

Element Research Group

San Antonio, Texas 78258

United States

University of Texas Health Science Center at Tyler

Tyler, Texas 75708

United States

Intermountain Healthcare

Murray, Utah 84107

United States

University of Vermont

Burlington, Vermont 05401

United States

Inova Fairfax Medical Campus

Falls Church, Virginia 22042

United States

Virginia Commonwealth University Health Systems

Richmond, Virginia 23219

United States

University of Washington

Seattle, Washington 98195

United States

Providence Medical Research Center

Spokane, Washington 99204

United States

University of Wisconsin

Madison, Wisconsin 53792

United States

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Centro Dr. Lazaro Langer S.R.L

Alberdi Sur, X5003DCE

Argentina

CEC- Centro de Especialidades Cardiovasculares

Bahía Blanca,

Argentina

Hospital Aleman

CABA, 1118

Argentina

Centro de Investigación Clinica Belgrano

CABA, 1425

Argentina

CEDIC - Centro de Investigacion Clinica

CABA, C1060ABN

Argentina

Mautalen- Salud e Investigacion

CABA, C1128AAF

Argentina

Equipo Ciencia

CABA, C1428BNF

Argentina

APRILLUS-Asistencia e Investigacion

Ciudad Autonoma Buenos Aires, C1046AAQ

Argentina

Instituto Ave Pulmo - Fundacion Enfisema

Mar del Plata, 7600

Argentina

Centro Respiratorio de Quilmes

Quilmes, B1878FNR

Argentina

Instituto de Especialidades de la Salud Rosario

Rosario, 2000

Argentina

Ibamedica

Santa Fe, 3000

Argentina

Canberra Hospital

Garran, Australian Capital Territory 2605

Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050

Australia

Macquarie University

North Ryde, New South Wales 2109

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Heart of Australia Research Institute

Chelmer, Queensland 4068

Australia

Lung Research Queensland

Chermside, Queensland 4032

Australia

The Prince Charles Hospital

Chermside, Queensland 4032

Australia

Greenslopes Private Hospital

Greenslopes, Queensland 4120

Australia

Mater Hospital Brisbane

South Brisbane, Queensland 4101

Australia

Queensland Children's Hospital

South Brisbane, Queensland 4101

Australia

Eastern Health-Box Hill Hospital

Box Hill, Victoria 3128

Australia

Peninsula Health

Frankston, Victoria 3199

Australia

Alfred Hospital

Melbourne, Victoria 3004

Australia

Institute for Respiratory Health

Nedlands, Western Australia 6009

Australia

Trialswest

Spearwood, Western Australia 6163

Australia

Medical University of Graz

Graz, 8036

Austria

Medical University of Innsbruck

Innsbruck, 6020

Austria

Cliniques Universitaires Saint-Luc

Brussels, 1200

Belgium

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

Vitaz - Campus Sint-Niklaas

Sint-Niklaas, 9100

Belgium

Serviços Medicos Respirar Sul Fluminense

Barra Mansa, 27323240

Brazil

Faculdade de Medicina de Botucatu - UNESP

Botucatu, 18618-687

Brazil

Chronos Pesquisa Clinica

Brasília, 72145-450

Brazil

HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

Goiânia, 74605-020

Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, 90035-074

Brazil

Netspiro Clinica Medica Ltda - Respsono

São Bernardo do Campo, 09750-420

Brazil

INCOR e Hospital das Clínicas da Universidade de São Paulo

São Paulo, 05403-000

Brazil

MHAT Rahila Angelova AD

Pernik, 2300

Bulgaria

DCC V - Plovdiv - St. Archbishop Luka

Plovdiv, 4023

Bulgaria

SHATPPD "Dr. Dimitar Gramatikov"

Rousse, 7002

Bulgaria

Multiprofile Hospital MHATEM 'Pirogov', Sofia

Sofia, 1606

Bulgaria

Diagnostics And Consultation Center Convex Ltd.

Sofia, 1680

Bulgaria

Medical Center "Pulmovision"

Sofia, 1756

Bulgaria

Medical Center Tara

Veliko Tarnovo, 5000

Bulgaria

Medical Center "Sveti Ivan Rilski"

Vidin, 3700

Bulgaria

Sbalpfz-Vratsa

Vratsa, 3001

Bulgaria

University of Calgary

Calgary, Alberta T2N 4Z6

Canada

St. Paul's Hospital (Vancouver)

Vancouver, British Columbia V6Z 1Y6

Canada

Cardio 1 Medical Clinic

Winnipeg, Manitoba R3L 1Z5

Canada

QEII Health Sciences Centre

Halifax, Nova Scotia B3H 3A7

Canada

BLC Clinical Research

Burlington, Ontario L7N 3V2

Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec H2X 0A9

Canada

Diex Recherche (Sherbrooke Est)

Sherbrooke, Quebec J1E 0N8

Canada

Diex Recherche (Trois-Rivieres)

Trois-Rivières, Quebec G9A 4P3

Canada

Royal University Hospital (Saskatoon)

Saskatoon, Saskatchewan S7N 0W8

Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Québec, G1V 4G5

Canada

Centro de Estudios Clínicos CEC

Santiago, 7750000

Chile

Centro de Investigación del Maule

Talca, 3465586

Chile

China-Japan Friendship Hospital

Beijing, 100029

China

Peking University People's Hospital

Beijing, 100044

China

Beijing Children's Hospital, Capital Medical University

Beijing, 100045

China

Peking University Third Hospital

Beijing, 100191

China

Peking Union Medical College Hospital

Beijing, 100730

China

The First Hospital of Jilin University

Changchun, 130000

China

The Second Hospital of Jilin University

Changchun, 130000

China

The Second Xiangya Hospital Of Central South University

Changsha, 410011

China

West China Hospital, Sichuan University

Chengdu, 610041

China

People's Hospital of Sichuan Province

Chengdu, 610072

China

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510000

China

Guangdong Provincial People's Hospital

Guangzhou, 510080

China

Guizhou People's Hospital

Guiyang, 550002

China

The First Affiliated Hospital, Zhejiang University

Hangzhou, 310003

China

Hangzhou First People's Hospital

Hangzhou, 310006

China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, 310009

China

Zhejiang Hospital

Hangzhou, 310013

China

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, 310016

China

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022

China

Huzhou Central Hospital

Huzhou, 313000

China

Jiangmen Central Hospital

Jiangmen, 529030

China

The First Affiliated Hospital of Nanchang University

Nanchang, 330006

China

The Second Affiliated Hospital to Nanchang University

Nanchang, 330006

China

Nanjing First Hospital

Nanjing, 210006

China

Nanjing Drum Tower Hospital

Nanjing, 210008

China

Affiliated Hospital of Nantong University

Nantong, 226001

China

Ningbo Medical Center Lihuili Hospital

Ningbo, 315000

China

The First Affiliated Hospital of Ningbo University

Ningbo, 315010

China

Pingxiang People's Hospital

Pingxiang, 337000

China

Qingdao Municipal Hospital

Qingdao, 266011

China

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, 362000

China

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, 200025

China

Zhongshan Hospital Affiliated to Fudan University

Shanghai, 200032

China

Huadong Hospital affiliated to Fudan University

Shanghai, 200040

China

Tongji Hospital, Tongji University

Shanghai, 200065

China

Shanghai General Hospital

Shanghai, 200080

China

Shanghai Fifth People's Hospital affiliated to Fudan University

Shanghai, 200240

China

Shanghai Pulmonary Hospital

Shanghai, 200433

China

The Children's Hospital of Fudan University

Shanghai, 201102

China

Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University

Shanghai, 201700

China

Shenzhen People's Hospital

Shenzhen, 518020

China

The First Affiliated Hospital of Soochow University

Suzhou, 215006

China

Tianjin Medical University General Hospital

Tianjin, 30052

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

Wenzhou People's Hospital

Wenzhou, 325006

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430056

China

Wuxi People's Hospital

Wuxi, 214043

China

First Affiliated Hospital of Xi'an JiaoTong University

Xi'an, 710061

China

Affiliated Hospital, Xuzhou Medical college

Xuzhou, 221006

China

Northern Jiangsu People's Hospital

Yangzhou, 225001

China

Yixing People'S Hospital

Yixing, 214258

China

Clinical Hospital Centar Sestre Milosrdnice

Zagreb, 10000

Croatia

Clinical Hospital Centre Zagreb

Zagreb, 10000

Croatia

MediTrial s.r.o.

Jindřichův Hradec, 377 01

Czechia

University Hospital Motol

Prague, 15000

Czechia

The First Pulmonary Private Practice

Prague, 19000

Czechia

Aalborg Sygehus Syd

Aalborg, 9000

Denmark

Aarhus University Hospital

Aarhus N, 8200

Denmark

Hvidovre Hospital

Hvidovre, 2650

Denmark

Copenhagen University Hospital, Rigshospitalet

København Ø, 2100

Denmark

Vejle University Hospital

Vejle, 7100

Denmark

Helsinki University Hospital

Helsinki, 00290 HUS

Finland

Oulun yliopistollinen keskussairaala

Oulu, 90220

Finland

Tampere University Hospital

Tampere, 33520

Finland

Turku University Hospital / TYKS

Turku, 20521

Finland

CHU Amiens-Picardie

Amiens, 80054

France

HOP Intercommunal

Créteil, 94000

France

INS Coeur Poumon

Lille, 59037

France

Hopital De La Croix-Rousse

Lyon, 69004

France

HOP Arnaud de Villeneuve

Montpellier, 34295

France

Hopital Pasteur

Nice, 06001

France

Hôpital Cochin

Paris, 75014

France

HOP Haut-Lévêque

Pessac, 33604

France

HOP Pontchaillou

Rennes, 35000

France

HOP Nord Laennec

Saint-Herblain, 44800

France

Hôpital Larrey - CHU de Toulouse

Tououse, 31059

France

Universitätsklinikum Aachen, AöR

Aachen, 52074

Germany

Velocity Clinical Research Germany GmbH, Ahrensburg

Ahrensburg, 22926

Germany

CIMS Studienzentrum Bamberg GmbH

Bamberg, 96049

Germany

Charité - Universitätsmedizin Berlin

Berlin, 10117

Germany

Vivantes Netzwerk für Gesundheit GmbH

Berlin, 12351

Germany

Evangelische Lungenklinik Berlin

Berlin, 13125

Germany

Charité - Universitätsmedizin Berlin

Berlin, 13353

Germany

Katholisches Klinikum Bochum gGmbH

Bochum, 44791

Germany

Universitätsklinikum Bonn AöR

Bonn, 53127

Germany

Augustiner Krankenhäuser GmbH

Cologne, 50678

Germany

Universitätsklinikum Köln (AöR)

Cologne, 50937

Germany

Caritas-Krankenhaus St. Maria gGmbH

Donaustauf, 93093

Germany

Klinikum Dortmund gGmbH

Dortmund, 44145

Germany

Technische Universität Dresden

Dresden, 01307

Germany

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45239

Germany

Universitätsklinikum Frankfurt

Frankfurt, 60590

Germany

IKF Pneumologie GmbH & Co. KG

Frankfurt, 60596

Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106

Germany

Asklepios Fachkliniken München-Gauting

Gauting, 82131

Germany

Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, 06120

Germany

Martin-Luther-Universität Halle-Wittenberg

Halle, 06120

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, 69126

Germany

Lungenfachklinik Immenhausen

Immenhausen, 34376

Germany

Universitätsklinikum Jena

Jena, 07747

Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105

Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131

Germany

Klinikum der Universität München AÖR

München, 80336

Germany

Pneumologisches Studienzentrum München-West

München, 81241

Germany

Universitätsklinikum Münster

Münster, 48149

Germany

Klinikum Ernst von Bergmann

Potsdam, 14467

Germany

Helios Hanseklinikum Stralsund

Stralstund, 18435

Germany

BAG Wiesbaden

Wiesbaden, 65183

Germany

Prince of Wales Hospital-Hong Kong-20715

Hong Kong, 999077

Hong Kong

Queen Mary Hospital

Hong Kong, 999077

Hong Kong

Koranyi National Institute For Pulmonolgy

Budapest, 1028

Hungary

BKS Research Ltd

Hatvan, H-3000

Hungary

Da Vinci Private Clinic

Pécs, 7635

Hungary

Cork University Hospital

Cork, T12 DC4A

Ireland

St. Vincent's University Hospital

Dublin, D04 T6F4

Ireland

Connolly Hospital Blanchardstown

Dublin, D15 X40D

Ireland

Lady Davis Carmel Medical Center

Haifa, 3436212

Israel

Hadassah Medical Center, Ein-Karem

Jerusalem, 9112001

Israel

Hadassah Medical Center, Ein-Karem

Jerusalem, 9765422

Israel

Rabin Medical Center Beilinson

Petah Tikva, 4941492

Israel

Sourasky Medical Center

Tel Aviv, 6423906

Israel

Azienda Ospedaliero Universitaria delle Marche

Ancona, 60126

Italy

Policlinico S. Orsola-Malpighi

Bologna, 40138

Italy

Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania

Catania, 95121

Italy

Azienda Ospedaliera San Martino

Genova, 16132

Italy

Istituto G. Gaslini

Genova, 16147

Italy

A.O.U.Policlinico G.Martino

Messina, 98124

Italy

Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico

Milan, 20122

Italy

Azienda Socio Sanitaria Territoriale Di Monza

Monza (MB), 20900

Italy

Azienda Ospedaliera dei Colli

Naples, 80131

Italy

Azienda Ospedaliera Universitaria di Padova

Padova, 35128

Italy

Policlinico "Paolo Giaccone"

Palermo, 90127

Italy

Fondazione IRCCS Policlinico S. Matteo

Pavia, 27100

Italy

Ospedale Pediatrico Bambino Gesù

Roma, 00165

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168

Italy

Istituto Clinico Humanitas

Rozzano (MI), 20089

Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126

Italy

Nagoya University Hospital

Aichi, Nagoya, 466-8560

Japan

Hirosaki University Hospital

Aomori, Hirosaki, 036-8563

Japan

Chiba University Hospital

Chiba, Chiba, 260-8677

Japan

Kameda Clinic

Chiba, Kamogawa, 296-0041

Japan

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582

Japan

Fukuoka Children's Hospital

Fukuoka, Fukuoka, 813-0017

Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180

Japan

Aso Co.,Ltd Iizuka Hospital

Fukuoka, Iizuka, 820-8505

Japan

Hokkaido University Hospital

Hokkaido, Sapporo, 060-8648

Japan

Terada Clinic, Respiratory Medicine & General practice

Hyogo, Himeji, 670-0849

Japan

University of Tsukuba Hospital

Ibaraki, Tsukuba, 305-8576

Japan

Kagoshima University Hospital

Kagoshima, Kagoshima, 890-8520

Japan

Kanagawa Cardiovascular and Respiratory Center

Kanagawa, Yokohama, 236-0051

Japan

Minami Kyoto Hospital

Kyoto, Joyo, 610-0113

Japan

Kyoto University Hospital

Kyoto, Kyoto, 606-8507

Japan

Matsusaka City Hospital

Mie, Matsusaka, 515-8544

Japan

Tohoku University Hospital

Miyagi, Sendai, 980-8574

Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, 852-8501

Japan

Niigata University Medical and Dental Hospital

Niigata, Niigata, 951-8520

Japan

Oita University Hospital

Oita, Yufu, 879-5593

Japan

Kurashiki Central Hospital

Okayama, Kurashiki, 710-8602

Japan

National Hospital Organization Kinki-Chuo Chest Medical Center

Osaka, Sakai, 591-8555

Japan

Osaka Toneyama Medical Center

Osaka, Toyonaka, 560-8552

Japan

Saga University Hospital

Saga, Saga, 849-8501

Japan

Saitama Cardiovascular and Respiratory Center

Saitama, Kumagaya, 360-0197

Japan

Shiga University of Medical Science Hospital

Shiga, Otsu, 520-2192

Japan

Matsue Medical Center

Shimane, Matsue, 690-8556

Japan

Hamamatsu University Hospital

Shizuoka, Hamamatsu, 431-3192

Japan

Tenryu Hospital

Shizuoka, Hamamatsu, 434-8511

Japan

Tokushima University Hospital

Tokushima, Tokushima, 770-8503

Japan

Institute of Science Tokyo Hospital

Tokyo, Bunkyo-ku, 113-8519

Japan

Nihon University Itabashi Hospital

Tokyo, Itabashi-ku, 173-8610

Japan

Fukujuji Hospital

Tokyo, Kiyose, 204-8522

Japan

Toranomon Hospital

Tokyo, Minato-ku, 105-8470

Japan

National Center for Child Health and Development

Tokyo, Setagaya-ku, 157-8535

Japan

Keio University Hospital

Tokyo, Shinjuku-ku, 160-8582

Japan

Tokyo Women's Medical University Hospital

Tokyo, Shinjuku-ku, 162-8666

Japan

Yamaguchi University Hospital

Yamaguchi, Ube, 755-8505

Japan

Multidisciplinary City Hospital №1 of the Akimat of Astana

Astana, 010000

Kazakhstan

Regional Clinical Hospital of the Health Department of the Karaganda Region

Karaganda, 100019

Kazakhstan

Veselibas centru apvieniba AS

Daugavpils, 5410

Latvia

Daugavpils regionala slimnica SIA

Daugavpils, 5417

Latvia

VCA Dubultu Medical center

Jūrmala, 2015

Latvia

Rigas 1. slimnica SIA

Riga, 1001

Latvia

Mediciniskas pecdiploma izglitibas instituts SIA

Riga, 1011

Latvia

Pauls Stradins Clinical University Hospital

Riga, LV-1002

Latvia

Rigas Austrumu kliniska universitates slimnica SIA

Upeslejas, 2118

Latvia

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, 50161

Lithuania

Republic Klaipeda Hospital

Klaipėda, 92231

Lithuania

Vilnius University Hospital, Santariskiu

Vilnius, 08406

Lithuania

Hospital Sultanah Bahiyah

Alor Setar, Kedah, 05460

Malaysia

Hospital Sultan Idris Shah Serdang

Kajang, 43000

Malaysia

Hospital Raja Perempuan Zainab II

Kelantan, 15586

Malaysia

Institut Perubatan Respiratori

Kuala Lumpur, 50586

Malaysia

University Malaya Medical Centre

Kuala Lumpur, 59100

Malaysia

Sarawak General Hospital

Kuching, 93586

Malaysia

Centro de Investigacion Integral MEDIVEST S.C

Chihuahua City, 31203

Mexico

Mediadvance Clinical S.A.P.I de C.V.

Chihuahua City, 31203

Mexico

Centro de Investigacion Farmacologica del Bajío, S.C.

León, 37160

Mexico

Soluciones terapeuticas medico quirurgicas S de RL de CV

Mexico City, 03650

Mexico

Oaxaca Site Management Organization, S.C.

Oaxaca City, 68000

Mexico

Asociación Mexicana para la Investigacion Clínica, A.C(AMIC)

Pachuca, 42070

Mexico

Clinical Research Institute S.C.

Tlalnepantla, 54055

Mexico

Arke SMO S.A. de C.V.

Veracruz de Ignacio de La Llave, 91900

Mexico

Noordwest Ziekenhuisgroep

Alkmaar, 1815 JD

Netherlands

Amsterdam UMC Locatie VUMC

Amsterdam, 1081HV

Netherlands

Erasmus Medisch Centrum-ROTTERDAM-50697

Rotterdam, 3015 GD

Netherlands

Haga Ziekenhuis

The Hague, 2545 AA

Netherlands

UMC Utrecht

Utrecht,

Netherlands

Gelre Ziekenhuis Zutphen

Zutphen, 7207 AE

Netherlands

NZ Respiratory and Sleep Institute

Greenlane East, Auckland 1051

New Zealand

Momentum Clinical Research Dunedin

Dunedin, Otago 9016

New Zealand

Waikato Hospital

Hamilton, Waikato Region 3240

New Zealand

Momentum Clinical Research

Mount Cook, Wellington Region 6021

New Zealand

Christchurch Hospital

Christchurch, 8011

New Zealand

Middlemore Clinical Trials

Papatoetoe, 2025

New Zealand

Momentum clinical Research Rotorua

Rotorua, 3010

New Zealand

Iloilo Doctors Hospital

Iloilo City, 5000

Philippines

West Visayas State University Medical Center

Iloilo City, 5000

Philippines

Health Cube Medical Clinics

Mandaluyong, 1552

Philippines

Quirino Memorial Medical Center

Quezon City, 1109

Philippines

Philippine General Hospital

Taft, Manila, 1000

Philippines

Respiratory Medicine Centre, private prac., Bialystok

Bialystok, 15044

Poland

M2M Med. Badania Sp. z o.o.

Chorzów, 41-500

Poland

Screenmed Sp. z o.o.

Piaseczno, 05500

Poland

EMED, Center of Medical Services,Private Prac,Rzeszow

Rzeszów, 35205

Poland

Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski

Warsaw, 01-456

Poland

Medical Center K2J2

Wołomin, 05200

Poland

ULS da Região de Aveiro

Aveiro, 3814-501

Portugal

ULS Braga

Braga, 4710-243

Portugal

CHUC - Centro Hospitalar e Universitario de Coimbra, EPE

Coimbra, 3004-561

Portugal

ULS do Alto Ave

Guimarães, 4835-045

Portugal

ULS da Região de Leiria, E.P.E.

Leiria, 2410-197

Portugal

ULS de Santa Maria, E.P.E

Lisbon, 1649-035

Portugal

Centro Hospitalar Universitário São João,EPE

Porto, 4202-451

Portugal

San Juan Bautista School of Medicine

Caguas, 00726

Puerto Rico

VA Caribbean Healthcare System

San Juan, 00921

Puerto Rico

Puerto Rico Consortium for Clinical Investigation

San Juan, 00927

Puerto Rico

Institutul De Pneumoftiziologie Marius Nasta

Bucharest, 050159

Romania

SC Medlife S.A

Cluj-Napoca, 400001

Romania

Spitalul Clinic De Pneumoftiziologie Leon Daniello

Cluj-Napoca, 400003

Romania

Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara

Timișoara, 300310

Romania

National University Hospital-Singapore-42005

Singapore, 119074

Singapore

Singapore General Hospital

Singapore, 169608

Singapore

Tan Tock Seng Hospital

Singapore, 308433

Singapore

Changi General Hospital

Singapore, 529889

Singapore

Univerzitna Nemocnica Martin

Martin, 036 01

Slovakia

Plucna ambulancia Hrebenar s.r.o.

Spišská Nová Ves, 05201

Slovakia

Iatros International

Bloemfontein, 9301

South Africa

Dr Ismail Abdullah

Cape Town, 7764

South Africa

Addington Hospital

Durban, 4001

South Africa

Enhancing Care Foundation NPC

Mount Edgecombe, 4301

South Africa

CAPRISA Offices on the King DinuZulu Hospital Complex

Springfield, 4091

South Africa

Hallym University Sacred Heart Hospital

Anyang, 14068

South Korea

Chungbuk National University Hospital

Chungju, 28644

South Korea

Yeongnam University Hospital

Daegu, 42415

South Korea

Ulsan University Hospital

Dong-gu Ulsan, 44033

South Korea

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, 21431

South Korea

Severance Hospital

Seoul, 03722

South Korea

Hanyang University Medical Center

Seoul, 04763

South Korea

Konkuk University Medical Center

Seoul, 05030

South Korea

Kangdong Sacred Heart Hospital

Seoul, 05355

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

The Catholic University of Korea, Seoul St.Mary's Hospital

Seoul, 06591

South Korea

SMG-SNU Boramae Medical Center

Seoul, 07071

South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, 22711

South Korea

Jeonbuk National University Hospital

Seoul, 54907

South Korea

Yonsei University Wonju Severance Christian Hospital

Wŏnju, 26426

South Korea

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006

Spain

Hospital Germans Trias i Pujol

Badalona, 08916

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clínic de Barcelona

Barcelona, 08036

Spain

Hospital Universitario Virgen de la Arrixaca

El Palmar, 30120

Spain

Hospital Universitari de Girona Doctor Josep Trueta

Girona, 17007

Spain

Hospital Infanta Elena

Huelva, 21080

Spain

Hospital Jerez de la Frontera

Jerez de la Frontera, 11407

Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, 08907

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital de Mérida

Mérida, 06800

Spain

Hospital Central de Asturias

Oviedo, 33011

Spain

Hospital Son Espases

Palma de Mallorca, 07120

Spain

Complejo Hospitalario de Navarra

Pamplona, 31008

Spain

Hospital Quirónsalud Madrid

Pozuelo de Alarcón, 28223

Spain

Hospital Universitario Puerto Real

Puerto Real, 11510

Spain

Hospital Universitario Marqués de Valdecilla

Santander, 39008

Spain

Complexo Hospitalario Universitario De Santiago

Santiago de Compostela, 15706

Spain

Hospital Universitario Virgen De La Macarena

Seville, 41009

Spain

Hospital Virgen del Rocío

Seville, 41013

Spain

Hospital Universitari i Politècnic La Fe

Valencia, 46026

Spain

Universitetssjukhuset, Örebro

Örebro, 703 62

Sweden

Karolinska University Hospital

Stockholm, SE-171 64

Sweden

CTC Clinical Trial Consultants AB

Uppsala, 751 85

Sweden

Universitätsspital Basel

Basel, 4031

Switzerland

University Hospital of Lausanne

Lausanne,

Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807

Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301

Taiwan

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

National Taiwan University Hospital

Taipei, 10048

Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333

Taiwan

National Taiwan University Hospital Yun-Lin Branch

Yunlin County, 632

Taiwan

Ramathibodi Hospital

Bangkok, 10400

Thailand

Siriraj Hospital

Bangkok, 10700

Thailand

Srinagarind Hospital

Khon Kaen, 40002

Thailand

Songklanagarind Hospital

Songkhla, 90110

Thailand

King Chulalongkorn Memorial Hospital

Thailand, 10330

Thailand

Ankara University Medical Faculty

Ankara, 06620

Turkey (Türkiye)

Belfast City Hospital

Belfast, BT9 7AB

United Kingdom

Heartlands Hospital

Birmingham, B9 5SS

United Kingdom

Blackpool Victoria Hospital

Blackpool, FY3 8NR

United Kingdom

Bradford Royal Infirmary

Bradford, BD9 6RJ

United Kingdom

Velocity Clinical Research, Bristol

Bristol, BS8 2RA

United Kingdom

Royal Papworth Hospital

Cambridge, CB2 0AY

United Kingdom

University Hospital Llandough

Cardiff, CF64 2XX

United Kingdom

Ninewells Hospital & Medical School

Dundee, Scotland, DD1 9SY

United Kingdom

University Hospital Hairmyres

East Kilbride, G75 8RG

United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA

United Kingdom

Royal Hospital for Children and Young People

Edinburgh, EH16 4TJ

United Kingdom

Western General Hospital

Edinburgh, EH4 2XU

United Kingdom

Freeman Hospital

High Heaton, NE7 7DN

United Kingdom

Royal Lancaster Infirmary

Lancaster, LA1 4RP

United Kingdom

St James's University Hospital

Leeds, LS9 7TF

United Kingdom

Liverpool Heart & Chest Hospital

Liverpool, L14 3PE

United Kingdom

King's College Hospital

London, SE5 9RS

United Kingdom

Royal Brompton Hospital

London, SW3 6NP

United Kingdom

Craigavon Area Hospital

Portadown, BT63 5QQ

United Kingdom

Northern General Hospital

Sheffield, S5 7AU

United Kingdom

Southampton General Hospital

Southampton, SO16 6YD

United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG

United Kingdom

Torbay Hospital

Torquay, TQ2 7AA

United Kingdom