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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by Boehringer Ingelheim
Sponsor
Boehringer Ingelheim
Information Provided by (Responsible Party)
Boehringer Ingelheim
Clinicaltrials.gov Identifier
NCT06238622
Other Study ID Numbers:
1305-0031
First Submitted
January 24, 2024
First Posted
February 1, 2024
Last Update Posted
April 14, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis
Drug: Nerandomilast

Study Design

Study TypeInterventional
Actual Enrollment1700 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn 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 Start DateMay 5, 2024
Actual Primary Completion Date1yr 3d from now
Actual Study Completion Date1yr 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
BI 1015550 treatment group
Drug: Nerandomilast
Nerandomilast

Outcome Measures

Primary Outcome Measures
  1. 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
Secondary Outcome Measures
  1. Absolute change from baseline in Forced vital capacity (FVC) (mL) over time
  2. Absolute change from baseline in % predicted in Forced vital capacity (FVC) over time
  3. Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial
  4. 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
  5. Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation or death over the duration of the trial
  6. Time to hospitalisation for respiratory cause or death over the duration of the trial
  7. Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
  8. Time to relative decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsBoehringer Ingelheim
Locations
University of Alabama at Birmingham | Birmingham Alabama, United States, 35233University of Arizona | Tucson Arizona, United States, 85724University of Southern California | Los Angeles California, United States, 90033Cedars-Sinai Medical Center | Los Angeles California, United States, 90048University of California Los Angeles | Los Angeles California, United States, 90095University of California Davis | Sacramento California, United States, 95817National Jewish Health | Denver Colorado, United States, 80206Yale University School of Medicine | New Haven Connecticut, United States, 06510Christiana Hospital | Newark Delaware, United States, 19713Georgetown University | Washington D.C. District of Columbia, United States, 20007St. Francis Medical Institute | Clearwater Florida, United States, 33765University of Florida | Gainesville Florida, United States, 32610Clinical Research Specialists LLC - Kissimmee | Kissimmee Florida, United States, 34746Advanced Pulmonary Research Institute | Loxahatchee Groves Florida, United States, 33470Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead | Atlanta Georgia, United States, 30309The Emory Clinic | Atlanta Georgia, United States, 30322Northshore University Health System | Evanston Illinois, United States, 60201University of Kansas Medical Center | Kansas City Kansas, United States, 66160Tulane Medical Center | New Orleans Louisiana, United States, 70112Johns Hopkins Hospital | Baltimore Maryland, United States, 21224Massachusetts General Hospital | Boston Massachusetts, United States, 02114Brigham and Women's Hospital | Boston Massachusetts, United States, 02115St. Elizabeth's Medical Center | Boston Massachusetts, United States, 02135Beth Israel Deaconess Medical Center | Boston Massachusetts, United States, 02215University of Michigan | Ann Arbor Michigan, United States, 48109Corewell Health William Beaumont University Hospital | Royal Oak Michigan, United States, 48073University of Minnesota | Minneapolis Minnesota, United States, 55455Mayo Clinic, Rochester | Rochester Minnesota, United States, 55905The Lung Research Center, LLC | Chesterfield Missouri, United States, 63017Creighton University | Omaha Nebraska, United States, 68124University of Nebraska Medical Center | Omaha Nebraska, United States, 68198Renown Regional Medical Center | Reno Nevada, United States, 89502Dartmouth-Hitchcock Medical Center | Lebanon New Hampshire, United States, 03756Northern Westchester Hospital | Mount Kisco New York, United States, 10549Columbia University Medical Center-New York Presbyterian Hospital | New York New York, United States, 10032NewYork-Presbyterian/Weill Cornell Medical Center | New York New York, United States, 10065Duke University Medical Center | Durham North Carolina, United States, 27710Southeastern Research Center-Winston Salem-69289 | Winston-Salem North Carolina, United States, 27103University of Cincinnati | Cincinnati Ohio, United States, 45267Cleveland Clinic | Cleveland Ohio, United States, 44195The Ohio State University Wexner Medical Center | Columbus Ohio, United States, 43210The Oregon Clinic | Portland Oregon, United States, 97220University of Pennsylvania | Philadelphia Pennsylvania, United States, 19104Temple University Hospital | Philadelphia Pennsylvania, United States, 19140Allegheny General Hospital | Pittsburgh Pennsylvania, United States, 15212Infinity Medical Research, Inc. | East Providence Rhode Island, United States, 02914Lowcountry Lung and Critical Care | Charleston South Carolina, United States, 29406Clinical Trials Center of Middle Tennessee, LLC | Franklin Tennessee, United States, 37067Vanderbilt University Medical Center | Nashville Tennessee, United States, 37204Baylor University Medical Center | Dallas Texas, United States, 75246UT Health San Antonio | San Antonio Texas, United States, 78229Intermountain Medical Center-Murray-69497 | Murray Utah, United States, 84107University of Utah Health Sciences Center | Salt Lake City Utah, United States, 84108University of Vermont | Burlington Vermont, United States, 05401Inova Fairfax Hospital | Falls Church Virginia, United States, 22042Virginia Mason Medical Center | Seattle Washington, United States, 98101University of Wisconsin | Madison Wisconsin, United States, 53792Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553 | C.a.b.a , Argentina, 1056CEDIC - Centro de Investigacion Clinica | CABA , Argentina, C1060ABNHospital Italiano de Buenos Aires | CABA , Argentina, C1199ABDConsultorios Médicos del Buen Ayre | Capital Federal , Argentina, 1425CEMER-Centro Medico De Enfermedades Respiratorias | Florida , Argentina, B1602DQDInstituto Ave Pulmo - Fundacion Enfisema | Mar del Plata , Argentina, 7600INSARES | Mendoza , Argentina, M5500CCGCentro Respiratorio de Quilmes | Quilmes , Argentina, B1878FNRInstituto Médico de la Fundación Estudios Clínicos | Rosario , Argentina, S2000DEJCanberra Hospital | Garran Australian Capital Territory, Australia, 2605Royal Prince Alfred Hospital | Camperdown New South Wales, Australia, 2050Westmead Hospital | Westmead New South Wales, Australia, 2145Lung Research Queensland | Chermside Queensland, Australia, 4032The Prince Charles Hospital | Chermside Queensland, Australia, 4032Royal Adelaide Hospital | Adelaide South Australia, Australia, 5000Austin Hospital | Heidelberg Victoria, Australia, 3084The Alfred Hospital | Melbourne Victoria, Australia, 3004Fiona Stanley Hospital | Murdoch Western Australia, Australia, 6150Trialswest | Spearwood Western Australia, Australia, 6163Macquarie University | Macquarie Park , Australia, 2109Krems University Hospital | Krems , Austria, 3500LKH Salzburg University Hospital | Salzburg , Austria, 5020AKH - Medical University of Vienna | Vienna , Austria, 1090Clinic Floridsdorf | Vienna , Austria, 1210Klinikum Wels - Grieskirchen GmbH | Wels , Austria, 4600Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim | Antwerp , Belgium, 2020ULB Hopital Erasme | Brussels , Belgium, 1070Cliniques Universitaires Saint-Luc | Brussels , Belgium, 1200Universitair Ziekenhuis Gent | Ghent , Belgium, 9000UZ Leuven | Leuven , Belgium, 3000Centre Hospitalier Universitaire de Liège | Liège , Belgium, 4000Yvoir - UNIV UCL de Mont-Godinne | Yvoir , Belgium, 5530Serviços Medicos Respirar Sul Fluminense | Barra Mansa , Brazil, 27323240Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMG) | Belo Horizonte,Minas Gerais , Brazil, 31270901SAPIENS - Instituto de Estudos e Pesquisa Clínica | Curitiba , Brazil, 80810-000CLARE - Clinica de Pneumologia | Goiânia , Brazil, 74110-030Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre , Brazil, 90020-090Hospital Nossa Senhora da Conceição | Porto Alegre - RS , Brazil, 91350-250CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo , Brazil, 09715-090Hospital Alemao Oswaldo Cruz | São Paulo , Brazil, 01327-001Hospital das Clinicas da Faculdade de Medicina da USP | São Paulo , Brazil, 05403-000University of Alberta Hospital (University of Alberta) | Edmonton Alberta, Canada, T6G 1Z1Kelowna Respirology & Allergy Research | Kelowna British Columbia, Canada, V1Y 3H5St. Paul's Hospital (Vancouver) | Vancouver British Columbia, Canada, V1Y 1S1Vancouver General Hospital | Vancouver British Columbia, Canada, V5Z 1M9Dr. Georges-L.-Dumont University Hospital Centre | Moncton New Brunswick, Canada, E1C 2Z3QEII Health Sciences Centre | Halifax Nova Scotia, Canada, B3H 3A7St. Joseph's Healthcare Hamilton | Hamilton Ontario, Canada, L8N 1Y2Dr. Syed Anees Medicine Professional Corporation | Windsor Ontario, Canada, N8X 1T3Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal Quebec, Canada, H2X 0C1McGill University Health Centre (MUHC) | Montreal Quebec, Canada, H4A 3J1CIC Mauricie (Trois Rivieres) | Trois-Rivières Quebec, Canada, G8T 7A1Royal University Hospital (Saskatoon) | Saskatoon Saskatchewan, Canada, S7N 0W8Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) | Québec , Canada, G1V 4G5Instituto Nacional del Tórax | Providencia, Santiago de Chile , Chile, 7500000Centro de Investigación del Maule | Talca , Chile, 3465586Beijing Chao-Yang Hospital | Beijing , China, 100020China-Japan Friendship Hospital | Beijing , China, 100029Peking Union Medical College Hospital | Beijing , China, 100730The Second Xiangya Hospital Of Central South University | Changsha , China, 410011West China Hospital, Sichuan University | Chengdu , China, 610041People's Hospital of Sichuan Province | Chengdu , China, 610072First Affiliated Hospital of Guangzhou Medical University | Guangzhou , China, 510120NanFang Hosptial | Guangzhou , China, 510515Hangzhou First People's Hospital | Hangzhou , China, 310006The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou , China, 310009Zhejiang Hospital | Hangzhou , China, 310013Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou , China, 310016Anhui Provincial Hospital | Hefei , China, 230001The Affiliated Hospital of Inner Mongolia Medical University | Hohhot , China, 010000The First hospital of Jiaxing | Jiaxing , China, 314000Jinhua Municipal Central Hospital | Jinhua , China, 321000Nanjing Drum Tower Hospital | Nanjing , China, 210008Ningbo Medical Center Lihuili Hospital | Ningbo , China, 315000The First Affiliated Hospital of Ningbo University | Ningbo , China, 315010Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai , China, 200025Shanghai Chest Hospital | Shanghai , China, 200030Zhongshan Hospital Affiliated to Fudan University | Shanghai , China, 200032Huadong Hospital affiliated to Fudan University | Shanghai , China, 200040China Shenyang Chest Hospital | Shenyang , China, 110000Shenzhen People's Hospital | Shenzhen , China, 518020The University of Hong Kong-Shenzhen Hospital | Shenzhen , China, 518053The First Affiliated Hospital of Soochow University | Suzhou , China, 215006Tianjin Medical University General Hospital | Tianjin , China, 30052The First Affiliated Hospital of Wenzhou Medical University | Wenzhou , China, 325000Wuhan Union Hospital | Wuhan , China, 430022Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T | Wuhan , China, 430030Renmin Hospital of Wuhan University | Wuhan , China, 430060Wuxi People's Hospital | Wuxi , China, 214043Second Affiliated Hospital of Xi'an JiaoTong University | Xi'an , China, 710004Affiliated Hospital, Xuzhou Medical college | Xuzhou , China, 221009Yichang Central People's Hospital | Yichang , China, 443000General Hospital of Ningxia Medical University | Yinchuan , China, 750004University hospital center Zagreb | Zagreb , Croatia, 10000University Hospital Dubrava | Zagreb , Croatia, 10000Solmed Polyclinic | Zagreb , Croatia, 1000University Thomayer´s Hospital | Prague , Czechia, 140 59Gentofte Hospital | Hellerup , Denmark, 2900Odense University Hospital | Odense C , Denmark, 5000North Estonia Medical Centre Foundation, Tallinn | Tallinn , Estonia, 13419HYKS Keuhkosairauksien tutkimusyksikkö | Helsinki , Finland, 00029Oulun yliopistollinen keskussairaala | Oulu , Finland, 90220Tampere University Hospital | Tampere , Finland, 33520TYKS | Turku , Finland, 20520HOP d'Angers | Angers , France, 49933HOP Avicenne | Bobigny , France, 93000HOP de la Cavale Blanche | Brest , France, 29200Hôpital Louis Pradel | Bron , France, 69677HOP CHU Caen | Caen , France, 14033HOP François Mitterrand | Dijon , France, 21000HOP Michallon | La Tronche , France, 38700HOP Bicêtre | Le Kremlin-Bicêtre , France, 94275INS Coeur Poumon | Lille , France, 59037HOP Nord | Marseille , France, 13915HOP Nord Laennec | Nantes , France, 44093Hôpital Pasteur | Nice , France, 06001HOP Paris Saint-Joseph | Paris , France, 75014HOP Européen G. Pompidou | Paris , France, 75015HOP Bichat | Paris , France, 75877HOP Haut-Lévêque | Pessac , France, 33604HOP Robert Debré | Reims , France, 51100HOP Pontchaillou | Rennes , France, 35033Hôpital Charles Nicolle | Rouen , France, 76031HOP Foch | Suresnes , France, 92151Hôpital Larrey - CHU de Toulouse | Toulouse , France, 31059National Center for Tuberculosis and Lung Diseases, Tbilisi | Tbilisi , Georgia, 0101LLC Diacor | Tbilisi , Georgia, 0159LTD The First Medical Center | Tbilisi , Georgia, 0180Velocity Clinical Research Germany GmbH, Ahrensburg | Ahrensburg , Germany, 22926CIMS Studienzentrum Bamberg GmbH | Bamberg , Germany, 96049Vivantes Netzwerk für Gesundheit GmbH | Berlin , Germany, 12351Universitätsklinikum Bonn AöR | Bonn , Germany, 53127Fachkrankenhaus Coswig GmbH | Coswig , Germany, 01640Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Essen , Germany, 45239Universitätsklinikum Hamburg, Eppendorf | Hamburg , Germany, 20246Klinikum Region Hannover GmbH | Hanover , Germany, 30459Medizinische Hochschule Hannover | Hanover , Germany, 30625Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg | Heidelberg , Germany, 69126Lungenklinik Hemer | Hemer , Germany, 58675Lungenfachklinik Immenhausen | Immenhausen , Germany, 34376Klinikum Konstanz | Konstanz , Germany, 78464Klinikum der Universität München AÖR | München , Germany, 81377Klinikum Nürnberg | Nuremberg , Germany, 90419Krankenhaus Bethanien gGmbH | Solingen , Germany, 42699Helios Hanseklinikum Stralsund | Stralsund , Germany, 18435Robert Bosch Gesellschaft für medizinische Forschung mbH | Stuttgart , Germany, 70376Universitätsklinikum Tübingen | Tübingen , Germany, 72076Hospital of Heraklion (PAGNI) | Heraklion , Greece, 71110Univ. Gen. Hosp. of Ioannina | Ioannina , Greece, 45 500Univ. Gen. Hosp. of Patras | Pátrai , Greece, 26504General Hospital of Thessaloniki "Hippokrateio" | Thessaloniki , Greece, 546 42Koranyi National Institute For Pulmonolgy | Budapest , Hungary, 1121University of Debrecen Clinical Centre | Debrecen , Hungary, 4032Bhatia Hospital | Mumbai , India, 400007P.D. Hinduja National Hospital | Mumbai , India, 400067Connolly Hospital Blanchardstown | Dublin , Ireland, D15 X40DShamir Medical Center (Assaf Harofeh) | Beer Yaakov , Israel, 7033001Lady Davis Carmel Medical Center | Haifa , Israel, 3436212Shaare Zedek Medical Center, Jerusalem 91031 | Jerusalem , Israel, 9103102Sourasky Medical Center | Tel Aviv , Israel, 6093246ASST degli Spedali Civili di Brescia | Brescia , Italy, 25123A.O.U. Policlinico Vittorio Emanuele | Catania , Italy, 95124A. O. Universitaria Careggi | Florence , Italy, 50137Ospedale Colonnello D Avanzo | Foggia , Italy, 71100Ospedale G.B. Morgagni | Forlì , Italy, 47121Ospedale San Paolo-MILANO-18793 | Milan , Italy, 20100Ospedale Classificato San Giuseppe | Milan , Italy, 20123Azienda Ospedaliero-Universitaria di Modena | Modena , Italy, 41100A.O. San Gerardo di Monza | Monza , Italy, 20052Azienda Ospedaliera Universitaria di Padova | Padova , Italy, 35128Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma , Italy, 00168A.O.U. Senese | Siena , Italy, 53100Ospedali Riuniti di Ancona | Torrette Di Ancona (Ancona) , Italy, 60126Tosei General Hospital | Aichi, Seto , Japan, 489-8642Chiba University Hospital | Chiba, Chiba , Japan, 260-8677University of Fukui Hospital | Fukui, Yoshida-gun , Japan, 910-1193National Hospital Organization Kyushu Medical Center | Fukuoka, Fukuoka , Japan, 810-8563Kyushu University Hospital | Fukuoka, Fukuoka , Japan, 812-8582Aso Co.,Ltd Iizuka Hospital | Fukuoka, Iizuka , Japan, 820-8505Hospital of the University of Occupational and Environmental Health | Fukuoka, Kitakyushu , Japan, 807-8556Kurume University Hospital | Fukuoka, Kurume , Japan, 830-0011Fukushima Medical University Hospital | Fukushima, Fukushima , Japan, 960-1295Tsuboi Hospital | Fukushima, Koriyama , Japan, 963-0197Hiroshima Prefectural Hospital | Hiroshima, Hiroshima , Japan, 734-8530Sapporo Medical University Hospital | Hokkaido, Sapporo , Japan, 060-8543Hokkaido University Hospital | Hokkaido, Sapporo , Japan, 060-8648National Hospital Organization Himeji Medical Center | Hyogo, Himeji , Japan, 670-8520Kobe City Medical Center General Hospital | Hyogo, Kobe , Japan, 650-0047Kobe City Hospital Organization Kobe City Medical Center West Hospital | Hyogo, Kobe , Japan, 653-0013Kagawa University Hospital | Kagawa, Kita-gun , Japan, 761-0793Kanagawa Cardiovascular and Respiratory Center | Kanagawa, Yokohama , Japan, 236-0051Saiseikai Kumamoto Hospital | Kumamoto, Kumamoto , Japan, 861-4193Tohoku University Hospital | Miyagi, Sendai , Japan, 980-8574Nagasaki University Hospital | Nagasaki, Nagasaki , Japan, 852-8501Kindai University Hospital | Osaka, Sakai , Japan, 590-0197National Hospital Organization Kinki-Chuo Chest Medical Center | Osaka, Sakai , Japan, 591-8555Osaka Medical and Pharmaceutical University Hospital | Osaka, Takatsuki , Japan, 569-8686Saitama Red Cross Hospital | Saitama, Saitama , Japan, 330-8553Shimane University Hospital | Shimane, Izumo , Japan, 693-8501Hamamatsu University Hospital | Shizuoka, Hamamatsu , Japan, 431-3192Jichi Medical University Hospital | Tochigi, Shimotsuke , Japan, 329-0498Tokushima University Hospital | Tokushima, Tokushima , Japan, 770-8503Juntendo University Hospital | Tokyo, Bunkyo-ku , Japan, 113-8431Nippon Medical School Hospital | Tokyo, Bunkyo-ku , Japan, 113-8603Toranomon Hospital | Tokyo, Minato-ku , Japan, 105-8470Kyorin University Hospital | Tokyo, Mitaka , Japan, 181-8611Toho University Omori Medical Center | Tokyo, Ota-ku , Japan, 143-8541Tokyo Medical University Hospital | Tokyo, Shinjuku-ku , Japan, 160-0023Keio University Hospital | Tokyo, Shinjuku-ku , Japan, 160-8582National Center for Global Health and Medicine | Tokyo, Shinjuku-ku , Japan, 162-8655Wakayama Medical University Hospital | Wakayama, Wakayama , Japan, 641-8510Hospital Pulau Pinang-Pulau Pinang-21953 | George Town , Malaysia, 10990Hospital Sultan Idris Shah Serdang | Kajang , Malaysia, 43000Institut Perubatan Respiratori | Kuala Lumpur , Malaysia, 53000Sarawak General Hospital | Kuching , Malaysia, 93586Centro de Investigacion Integral MEDIVEST S.C | Chihuahua City , Mexico, 31203CREPID Aire y Salud Integral | Coyoacán , Mexico, 04380Centro de Investigacion Farmacologica del Bajío, S.C. | León , Mexico, 37160Soltmed Smo | Mexico City , Mexico, 03650Centro Respiratorio de Mexico | Mexico City , Mexico, 14050Centro de Prevención y Rehabilitación de Enfermedades Pulmon | Monterrey , Mexico, 64460Oaxaca Site Management Organization, S.C. | Oaxaca City , Mexico, 68000Zuyderland Medisch Centrum | HEERLENHeerlen , Netherlands, 6419Leids Universitair Medisch Centrum (LUMC) | Leiden , Netherlands, 2333St. Antonius Ziekenhuis | Nieuwegein , Netherlands, 3435 CMErasmus Medisch Centrum-ROTTERDAM-50697 | Rotterdam , Netherlands, 3015Aotearoa Clinical Trials | Papatoetoe Auckland, New Zealand, 2025Waikato Hospital | Hamilton , New Zealand, 3204Greenlane Clinical Centre | One Tree Hill, Auckland , New Zealand, 1051Tauranga Hospital | Tauranga South , New Zealand, 3112Haukeland Universitetssykehus | Bergen , Norway, N-5021Akershus Universitetssykehus HF | Nordbyhagen , Norway, 1478Oslo Universitetssykehus HF, Rikshospitalet | Oslo , Norway, 0372University Clinical Center, Gdansk | Gdansk , Poland, 80-214Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ. | Katowice , Poland, 40-635Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o. | Świdnik , Poland, 21 040Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa | Warsaw , Poland, 01-138University Clinical Center of the Medical University of Warsaw | Warsaw , Poland, 02097ULS Braga | Braga , Portugal, 4710-243CHUC - Centro Hospitalar e Universitário de Coimbra, EPE | Coimbra , Portugal, 3004-561ULS de São José, E.P.E. | Lisbon , Portugal, 1169-024USLM, EPE - Hospital Pedro Hispano | Matosinhos Municipality , Portugal, 4454-509Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E | Vila Nova de Gaia , Portugal, 4434-502King Abdullah International Medical Research Center | Riyadh , Saudi Arabia, 11481University Clinical Center of Serbia | Belgrade , Serbia, 11000Institute for Pulmonary Diseases of Vojvodina | Kamenitz , Serbia, 21204University Clinical Center Nis | Niš , Serbia, 18000Singapore General Hospital | Singapore , Singapore, 169608Tan Tock Seng Hospital | Singapore , Singapore, 308433Hospital Golnik - Univ. Clinic of Pulmonary and Allergic Diseases | Golnik , Slovenia, 4204Enhancing Care Foundation NPC | Mount Edgecombe , South Africa, 4301The Catholic University of Korea, Bucheon St.Mary's Hospital | Bucheon-si , South Korea, 14647Seoul National University Bundang Hospital | Seongnam , South Korea, 13620Kyung Hee University Hospital | Seoul , South Korea, 02447Seoul National University Hospital | Seoul , South Korea, 03080Severance Hospital | Seoul , South Korea, 03722Soonchunhyang University Hospital Seoul | Seoul , South Korea, 04401Asan Medical Center | Seoul , South Korea, 05505Samsung Medical Center | Seoul , South Korea, 135-710Hospital General Universitario de Alicante | Alicante , Spain, 03010Hospital del Mar | Barcelona , Spain, 08003Hospital Universitari Vall d'Hebron | Barcelona , Spain, 08035Hospital Clínic de Barcelona | Barcelona , Spain, 08036Hospital de Basurto | Bilbao , Spain, 48013Hospital Universitario Virgen de la Arrixaca | El Palmar , Spain, 30120Hospital de Galdakao | Galdakao , Spain, 48960Hospital Universitario Virgen de las Nieves | Granada , Spain, 18014Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat , Spain, 08907Hospital Universitario De La Princesa | Madrid , Spain, 28006Hospital General Universitario Gregorio Marañón | Madrid , Spain, 28007Hospital Universitario Infanta Leonor | Madrid , Spain, 28031Hospital Universitario Ramon Y Cajal | Madrid , Spain, 28034Hospital Universitario 12 de Octubre | Madrid , Spain, 28041Hospital Universitario Virgen de la Victoria | Málaga , Spain, 29010Hospital Central de Asturias | Oviedo , Spain, 33011Hospital Son Espases | Palma de Mallorca , Spain, 07120Hospital Quirónsalud Madrid | Pozuelo de Alarcón , Spain, 28223Hospital Universitario Marqués de Valdecilla | Santander , Spain, 39008Hospital Clínico de Santiago | Santiago de Compostela , Spain, 15706Hospital Virgen del Rocío | Seville , Spain, 41013Hospital Nuestra Señora de Valme | Seville , Spain, 41014Hospital General Universitario de Valencia | Valencia , Spain, 46014Universitetssjukhuset, Linköping | Linköping , Sweden, 581 85Akademiska sjukhuset | Uppsala , Sweden, 75185Universitätsspital Basel | Basel , Switzerland, 4031Changhua Christian Hospital | Changhua , Taiwan, 500Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City , Taiwan, 83301Taichung Veterans General Hospital | Taichung , Taiwan, 407NCKUH | Tainan , Taiwan, 704National Taiwan University Hospital | Taipei , Taiwan, 100Taipei Veterans General Hospital | Taipei , Taiwan, 11217Siriraj Hospital | Bangkok Noi , Thailand, 10700Srinagarind Hospital | Khon Kaen , Thailand, 40002Maharat Nakhonchiangmai Hospital | Muang , Thailand, 50200Ramathibodi Hospital | Ratchatewi , Thailand, 10400Songklanagarind Hospital | Songkhla , Thailand, 90110Gulhane Training and Research Hospital | Ankara , Turkey (Türkiye), 06010Ankara Universitesi Tip Fakultesi | Ankara , Turkey (Türkiye), 06620Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606 | Antalya , Turkey (Türkiye), 07070Istanbul Universitesi Istanbul Tip Fakultesi | Istanbul , Turkey (Türkiye), 34390Gazi Universitesi Tip Fakultesi | Yenimahalle/ANKARA , Turkey (Türkiye), 06560Aberdeen Royal Infirmary | Aberdeen , United Kingdom, AB25 2ZNQueen Elizabeth Hospital Birmingham | Birmingham , United Kingdom, B15 2GWSouthmead Hospital | Bristol , United Kingdom, BS10 5NBRoyal Infirmary of Edinburgh | Edinburgh , United Kingdom, EH16 4SARoyal Devon and Exeter Hospital | Exeter , United Kingdom, EX2 5DWRoyal Lancaster Infirmary | Lancaster , United Kingdom, LA1 4RPSt James's University Hospital | Leeds , United Kingdom, LS9 7TFGuy's Hospital | London , United Kingdom, SE1 9RTRoyal Brompton Hospital | London , United Kingdom, SW3 6NPAltnagelvin Area Hospital | Londonderry , United Kingdom, BT47 6SBWythenshawe Hospital | Manchester , United Kingdom, M23 9QZChurchill Hospital | Oxford , United Kingdom, OX3 7LESouthampton General Hospital | Southampton , United Kingdom, SO16 6YD