Clinical trial NCT06238622: A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
Official title: An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-02-02
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.

The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.

Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.

Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.


Eligibility criteria: Inclusion Criteria:

1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control

Exclusion Criteria:

1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:

   * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
   * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \>14 at Visit 1.
4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
5. Patient will undergo lung transplantation, with an assigned date of surgery.
6. Patients with a Body Mass index (BMI) \<18.5 kg/m² that experienced an additional, unexplained and clinically significant (\>10%) weight loss during the parent trial
7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.

Further exclusion criteria apply.

Primary outcomes:
measure: Occurrence of any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99
timeFrame: Up to 99 weeks and 3 days
Secondary outcomes:
measure: Absolute change from baseline in Forced vital capacity (FVC) (mL) over time
timeFrame: Up to 98 weeks
measure: Absolute change from baseline in % predicted in Forced vital capacity (FVC) over time
timeFrame: Up to 98 weeks
measure: Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial
timeFrame: Up to 98 weeks
measure: Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial
timeFrame: Up to 98 weeks
measure: Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation or death over the duration of the trial
timeFrame: Up to 98 weeks
measure: Time to hospitalisation for respiratory cause or death over the duration of the trial
timeFrame: Up to 98 weeks
measure: Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
timeFrame: Up to 98 weeks
measure: Time to relative decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
timeFrame: Up to 98 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Clearwater
country: United States
facility: St. Francis Medical Institute
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Kissimmee
country: United States
facility: Clinical Research Specialists LLC
state: Florida
city: Loxahatchee Groves
country: United States
facility: Advanced Pulmonary Research Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Royal Oak
country: United States
facility: Corewell Health William Beaumont University Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic, Rochester
state: Minnesota
city: Chesterfield
country: United States
facility: The Lung Research Center, LLC
state: Missouri
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center-New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian/Weill Cornell Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center-Winston Salem-69289
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: East Providence
country: United States
facility: Infinity Medical Research, Inc.
state: Rhode Island
city: Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee, LLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center-Murray-69497
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: C.a.b.a
country: Argentina
facility: Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
city: Caba
country: Argentina
facility: CEDIC - Centro de Investigacion Clinica
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Capital Federal
country: Argentina
facility: Consultorios Médicos del Buen Ayre
city: Florida
country: Argentina
facility: CEMER-Centro Medico De Enfermedades Respiratorias
city: Mar del Plata
country: Argentina
facility: Instituto Ave Pulmo
city: Mendoza
country: Argentina
facility: INSARES
city: Quilmes
country: Argentina
facility: Centro Respiratorio de Quilmes
city: Rosario
country: Argentina
facility: Instituto Médico de la Fundación Estudios Clínicos
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Chermside
country: Australia
facility: Lung Research Queensland
state: Queensland
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Spearwood
country: Australia
facility: Trialswest
state: Western Australia
city: Macquarie Park
country: Australia
facility: Macquarie University
city: Krems
country: Austria
facility: Krems University Hospital
city: Salzburg
country: Austria
facility: LKH Salzburg University Hospital
city: Vienna
country: Austria
facility: AKH - Medical University of Vienna
city: Vienna
country: Austria
facility: Clinic Floridsdorf
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen GmbH
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
city: Bruxelles
country: Belgium
facility: ULB Hopital Erasme
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Gent
country: Belgium
facility: UNIV UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Yvoir
country: Belgium
facility: Yvoir - UNIV UCL de Mont-Godinne
city: Barra Mansa
country: Brazil
facility: Serviços Medicos Respirar Sul Fluminense
city: Belo Horizonte,Minas Gerais
country: Brazil
facility: Hospital das Clinicas da Universidade Federal HC-UFMG
city: Curitiba
country: Brazil
facility: Edumed - Educacao e Saude SA
city: Goiania
country: Brazil
facility: CLARE - Clinica de Pneumologia
city: Porto Alegre - RS
country: Brazil
facility: Hospital Nossa Senhora da Conceição
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: São Bernardo do Campo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da FMUSP
city: Edmonton
country: Canada
facility: University of Alberta Hospital (University of Alberta)
state: Alberta
city: Kelowna
country: Canada
facility: Kelowna Respirology & Allergy Research
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital (Vancouver)
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Moncton
country: Canada
facility: Dr. Georges-L.-Dumont University Hospital Centre
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Windsor
country: Canada
facility: Dr. Syed Anees Medicine Professional Corporation
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
city: Trois-Rivieres
country: Canada
facility: CIC Mauricie Inc.
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital (Saskatoon)
state: Saskatchewan
city: Quebec
country: Canada
facility: IUCPQ (Laval University)
city: Providencia, Santiago De Chile
country: Chile
facility: Instituto Nacional del Tórax
city: Talca
country: Chile
facility: Centro de Investigación del Maule
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital Of Central South University
city: Chengdu
country: China
facility: West China Hospital
city: Chengdu
country: China
facility: People's Hospital of Sichuan Province
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: NanFang Hosptial
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
city: Jiaxing
country: China
facility: The First hospital of Jiaxing
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
city: Shanghai
country: China
facility: Huadong Hospital affiliated to Fudan University
city: Shenyang
country: China
facility: China Shenyang Chest Hospital
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
city: Shenzhen
country: China
facility: The University of Hong Kong-Shenzhen Hospital
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Med College
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Wuhan
country: China
facility: Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xi'an JiaoTong University
city: Xuzhou
country: China
facility: Affiliated Hospital, Xuzhou Medical college
city: Yichang
country: China
facility: Yichang NO.1 People's Hospital
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Zagreb
country: Croatia
facility: University hospital center Zagreb
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Zagreb
country: Croatia
facility: Solmed Polyclinic
city: Praha 4
country: Czechia
facility: Thomayer University Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation, Tallinn
city: Helsinki
country: Finland
facility: HYKS Keuhkosairauksien tutkimusyksikkö
city: Oulu
country: Finland
facility: Oulun yliopistollinen keskussairaala
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: TYKS
city: Angers
country: France
facility: HOP d'Angers
city: Bobigny
country: France
facility: HOP Avicenne
city: Brest
country: France
facility: HOP de la Cavale Blanche
city: Bron
country: France
facility: HOP Louis Pradel
city: Caen
country: France
facility: HOP CHU Caen
city: Dijon
country: France
facility: HOP François Mitterrand
city: La Tronche
country: France
facility: HOP Michallon
city: Le Kremlin-Bicêtre
country: France
facility: HOP Bicêtre
city: Lille
country: France
facility: INS Coeur Poumon
city: Marseille
country: France
facility: HOP Nord
city: Nantes
country: France
facility: HOP Nord Laennec
city: Nice
country: France
facility: HOP Pasteur
city: Paris
country: France
facility: HOP Paris Saint-Joseph
city: Paris
country: France
facility: HOP Européen G. Pompidou
city: Paris
country: France
facility: HOP Bichat
city: Pessac
country: France
facility: HOP Haut-Lévêque
city: Reims
country: France
facility: HOP Robert Debré
city: Rennes
country: France
facility: HOP Pontchaillou
city: Rouen
country: France
facility: HOP Charles Nicolle
city: Suresnes
country: France
facility: HOP Foch
city: Toulouse
country: France
facility: HOP Larrey
city: Tbilisi
country: Georgia
facility: National Center for Tuberculosis and Lung Diseases, Tbilisi
city: Tbilisi
country: Georgia
facility: LLC Diacor
city: Ahrensburg
country: Germany
facility: Velocity Clinical Research Germany GmbH-Ahrensburg-69816
city: Bamberg
country: Germany
facility: CIMS Studienzentrum Bamberg GmbH
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn AöR
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig GmbH
city: Essen
country: Germany
facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg, Eppendorf
city: Hannover
country: Germany
facility: Klinikum Region Hannover GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Konstanz
country: Germany
facility: Klinikum Konstanz
city: München
country: Germany
facility: Klinikum der Universität München AÖR
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Solingen
country: Germany
facility: Krankenhaus Bethanien gGmbH
city: Stralsund
country: Germany
facility: Helios Hanseklinikum Stralsund
city: Stuttgart
country: Germany
facility: Robert Bosch Gesellschaft für medizinische Forschung mbH
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Heraclion
country: Greece
facility: Hospital of Heraklion (PAGNI)
city: Ioannina
country: Greece
facility: Univ. Gen. Hosp. of Ioannina
city: Patras
country: Greece
facility: Univ. Gen. Hosp. of Patras
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Hippokrateio"
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Koranyi National Institute For Pulmonolgy
city: Debrecen
country: Hungary
facility: University of Debrecen Clinical Centre
city: Mumbai
country: India
facility: Bhatia Hospital
city: Mumbai
country: India
facility: P.D. Hinduja National Hospital
city: Dublin 15
country: Ireland
facility: Connolly Hospital Blanchardstown
city: Beer Yaakov
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center, Jerusalem 91031
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele
city: Firenze
country: Italy
facility: A. O. Universitaria Careggi
city: Foggia
country: Italy
facility: Ospedale Colonnello D Avanzo
city: Forli'
country: Italy
facility: Ospedale G.B. Morgagni
city: Milano
country: Italy
facility: Ospedale San Paolo-MILANO-18793
city: Milano
country: Italy
facility: Ospedale Classificato San Giuseppe
city: Modena
country: Italy
facility: Azienda Ospedaliera Policlinico di Modena
city: Monza
country: Italy
facility: A.O. San Gerardo di Monza
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria alle Scotte
city: Torrette Di Ancona (Ancona)
country: Italy
facility: Ospedali Riuniti di Ancona
city: Aichi, Seto
country: Japan
facility: Tosei General Hospital
city: Chiba, Chiba
country: Japan
facility: Chiba University Hospital
city: Fukui, Yoshida-gun
country: Japan
facility: University of Fukui Hospital
city: Fukuoka, Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka, Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka, Iizuka
country: Japan
facility: Aso Co.,Ltd Iizuka Hospital
city: Fukuoka, Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Environmental Health
city: Fukuoka, Kurume
country: Japan
facility: Kurume University Hospital
city: Fukushima, Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Fukushima, Koriyama
country: Japan
facility: Tsuboi Hospital
city: Hiroshima, Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Hyogo, Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Hyogo, Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
city: Hyogo, Kobe
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center West Hospital
city: Kagawa, Kita-gun
country: Japan
facility: Kagawa University Hospital
city: Kanagawa, Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Kumamoto, Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Miyagi, Sendai
country: Japan
facility: Tohoku University Hospital
city: Nagasaki, Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Osaka, Osakasayama
country: Japan
facility: Kindai University Hospital
city: Osaka, Sakai
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Osaka, Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Saitama, Saitama
country: Japan
facility: Saitama Red Cross Hospital
city: Shimane, Izumo
country: Japan
facility: Shimane University Hospital
city: Shizuoka, Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Tochigi, Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Tokushima, Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo, Minato-ku
country: Japan
facility: Toranomon Hospital
city: Tokyo, Mitaka
country: Japan
facility: Kyorin University Hospital
city: Tokyo, Ota-ku
country: Japan
facility: Toho University Omori Medical Center
city: Tokyo, Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo, Shinjuku-ku
country: Japan
facility: Keio University Hospital
city: Tokyo, Shinjuku-ku
country: Japan
facility: National Center for Global Health and Medicine
city: Wakayama, Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St.Mary's Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital Seoul
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang-Pulau Pinang-21953
city: Kajang
country: Malaysia
facility: Hospital Sultan Idris Shah Serdang
city: Kuala Lumpur
country: Malaysia
facility: Institut Perubatan Respiratori
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Chihuahua
country: Mexico
facility: Centro de Investigacion Integral MEDIVEST S.C
city: Ciudad de Mexico
country: Mexico
facility: Soltmed Smo
city: Ciudad de Mexico
country: Mexico
facility: Centro Respiratorio de Mexico
city: Coyoacan
country: Mexico
facility: CREPID Aire y Salud
city: Guanajuato
country: Mexico
facility: Centro de Investigacion Farmacologica del Bajío, S.C.
city: Monterrey
country: Mexico
facility: Centro de Prevención y Rehabilitación de Enfermedades Pulmon
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization, S.C.
city: HEERLENHeerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC)
city: Nieuwegein
country: Netherlands
facility: St. Antonius ziekenhuis, locatie Nieuwegein
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum-ROTTERDAM-50697
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: One Tree Hill, Auckland
country: New Zealand
facility: Greenlane Clinical Centre
city: Tauranga South
country: New Zealand
facility: Tauranga Hospital
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Nordbyhagen
country: Norway
facility: Akershus Universitetssykehus HF
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Rikshospitalet
city: Gdansk
country: Poland
facility: University Clinical Center, Gdansk
city: Katowice
country: Poland
facility: Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
city: Swidnik
country: Poland
facility: Alergopneuma Medical Center
city: Warsaw
country: Poland
facility: Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
city: Warsaw
country: Poland
facility: University Clinical Center of the Medical University of Warsaw
city: Braga
country: Portugal
facility: ULS Braga
city: Coimbra
country: Portugal
facility: ULS de Coimbra, E.P.E.
city: Lisboa
country: Portugal
facility: ULS de São José, E.P.E.
city: Matosinhos
country: Portugal
facility: USLM, EPE - Hospital Pedro Hispano
city: Vila Nova de Gaia
country: Portugal
facility: ULS de Gaia/Espinho, EPE
city: Riyadh
country: Saudi Arabia
facility: King Abdullah International Medical Research Center
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Nis
country: Serbia
facility: University Clinical Center Nis
city: Sremska Kamenica
country: Serbia
facility: Institute for Pulmonary Diseases of Vojvodina
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Golnik
country: Slovenia
facility: Hospital Golnik - Univ. Clinic of Pulmonary and Allergic Diseases
city: Mount Edgecombe
country: South Africa
facility: Enhancing Care Foundation NPC
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Galdakao
country: Spain
facility: Hospital de Galdakao
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Quirónsalud Madrid
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora de Valme
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Linköping
country: Sweden
facility: Universitetssjukhuset, Linköping
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Changhua
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: NCKUH
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Muang
country: Thailand
facility: Maharat Nakhonchiangmai Hospital
city: Ratchatewi
country: Thailand
facility: Ramathibodi Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi
city: Yenimahalle/ANKARA
country: Turkey
facility: Gazi Universitesi Tip Fakultesi
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital, Wonford
city: Lancaster
country: United Kingdom
facility: Royal Lancaster Infirmary
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
References: