1,177
Participants
Start Date
October 6, 2022
Primary Completion Date
August 16, 2024
Study Completion Date
December 17, 2024
BI 1015550
Participants received film-coated nerandomilast tablets orally twice daily at doses of either 9 mg or 18 mg, with each dose administered at least 12 hours apart and taken with 250 mL of water.
Placebo
Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.
National Taiwan University Hospital, Taipei
Taichung Veterans General Hospital, Taichung
Chang-Hua Christian Hospital, Changhua
NCKUH, Tainan City
Greenlane Clinical Centre, One Tree Hill, Auckland
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553, C.a.b.a
ULB Hopital Erasme, Brussels
AKH - Medical University of Vienna, Vienna
Koranyi National Institute For Pulmonolgy, Budapest
Cliniques Universitaires Saint-Luc, Brussels
Clinic Floridsdorf, Vienna
Akershus Universitetssykehus HF, Lørenskog
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim, Antwerp
Middlemore Clinical Trials, Papatoetoe
Royal Prince Alfred Hospital, Camperdown
Westmead Hospital, Westmead
Canberra Hospital, Canberra
Herlev and Gentofte Hospital, Hellerup
UZ Leuven, Leuven
The Alfred Hospital, Melbourne
Lung Research Victoria, Footscray
Austin Hospital, Heidelberg
Tauranga Hospital, Tauranga South
Waikato Hospital, Hamilton
Krems University Hospital, Krems
Centre Hospitalier Universitaire de Liège, Liège
Universitätsspital Basel, Basel
Lung Research Queensland, Chermside
The Prince Charles Hospital, Chermside
University of Debrecen Clinical Centre, Debrecen
KwaPhila Health Solutions, Durban
Mater Hospital Brisbane, South Brisbane
Princess Alexandra Hospital, Woolloongabba
Klinikum Wels - Grieskirchen GmbH, Wels
Odense University Hospital, Odense
LKH Salzburg University Hospital, Salzburg
Yvoir - UNIV UCL de Mont-Godinne, Yvoir
Fiona Stanley Hospital, Murdoch
Trialswest, Spearwood
Busamed Paardevlei Private Hospital, Cape Town
Instituto Ave Pulmo, Mar del Plata
Melomed Gatesville Hospital, Cape Town
Aarhus University Hospital, Aarhus N
UNIV UZ Gent, Ghent
LKH Klagenfurt am Woerthersee, Klagenfurt
University Hospital Dubrava, Zagreb
Columbia University Medical Center-New York Presbyterian Hospital, New York
Weill Cornell Medicine-New York-59955, New York
Ramathibodi Hospital, Ratchatewi
Northern Westchester Hospital, Mount Kisco
Siriraj Hospital, Bangkok Noi
Hospital Pulau Pinang-Pulau Pinang-21953, Pulau Pinang
Central Chest Institute of Thailand, Muang
Taipei Veterans General Hospital, Taipei
Vivantes Netzwerk für Gesundheit GmbH, Berlin
North Estonia Medical Centre Foundation, Tallinn, Tallinn
Seoul National University Bundang Hospital, Seongnam
HOP Nord, Marseille
HOP CHU Caen, Caen
Centro Respiratorio de Mexico, Mexico City
The Catholic University of Korea, Bucheon St.Mary's Hospital, Bucheon-si
Allegheny General Hospital, Pittsburgh
Hospital Clínico de Santiago, Santiago de Compostela
Hospital Universitari de Girona Doctor Josep Trueta, Girona
Hospital Universitario Virgen de las Nieves, Granada
Helios Hanseklinikum Stralsund, Stralsund
University of Pennsylvania, Philadelphia
Jefferson Health Honickman Center, Philadelphia
Temple University Hospital, Philadelphia
Christiana Hospital, Newark
Georgetown University, Washington D.C.
Ospedale Classificato San Giuseppe, Milan
Universitätsklinikum Hamburg, Eppendorf, Hamburg
HOP François Mitterrand, Dijon
Alergopneuma Medical Center, Świdnik
Velocity Clinical Research Germany GmbH, Ahrensburg, Ahrensburg
Univ. Gen. Hosp. of Patras, Pátrai
Hospital Universitario Lucus Augusti, Lugo
Southeastern Research Center-Winston-Salem-61365, Winston-Salem
Duke University Medical Center, Durham
Hospital La Princesa, Madrid
Hospital General Universitario Gregorio Marañón, Madrid
Hospital Universitario Infanta Leonor, Madrid
Hospital Universitario Ramon Y Cajal, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Quirónsalud Madrid, Pozuelo de Alarcón
Hospital Virgen de la Victoria, Málaga
HOP de la Cavale Blanche, Brest
Lowcountry Lung and Critical Care, Charleston
Tianjin Medical University General Hospital, Tianjin
Hospital Universitario Virgen de la Arrixaca, El Palmar
Piedmont Healthcare-Atlanta-57055, Atlanta
Klinikum Region Hannover GmbH, Hanover
Medizinische Hochschule Hannover, Hanover
HOP Larrey, Toulouse
Centro de Investigacion Integral MEDIVEST S.C, Chihuahua City
Destin Pulmonary Critical Care, Santa Rosa Beach
University of Florida Health Shands Hospital, Gainesville
Hospital Central de Asturias, Oviedo
Advanced Pulmonary Research Institute, Loxahatchee Groves
HOP Haut-Lévêque, Pessac
St. Francis Medical Institute, Clearwater
Lungenfachklinik Immenhausen, Immenhausen
Clinical Research Specialists LLC, Kissimmee
HOP Pontchaillou, Rennes
Azienda Ospedaliera Universitaria di Padova, Padua
University of Alabama at Birmingham, Birmingham
HOP Bretonneau, Tours
Clinical Trials Center of Middle Tennessee, LLC, Franklin
Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks, Nashville
HOP Michallon, La Tronche
Hospital Universitario Marqués de Valdecilla, Santander
Srinagarind Hospital, Khon Kaen
Louisville Pulmonary Care, Louisville
Hospital Virgen del Rocío, Seville
Hospital Nuestra Señora de Valme, Seville
Azienda Ospedaliera Policlinico di Modena, Modena
Petrus-Krankenhaus, Wuppertal
Krankenhaus Bethanien gGmbH, Solingen
Hospital Sultan Idris Shah Serdang, Kajang
The Ohio State University Wexner Medical Center, Columbus
HOP Nord Laennec, Nantes
Cleveland Clinic, Cleveland
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH, Essen
University of Cincinnati, Cincinnati
Hospital General Universitario de Valencia, Valencia
Ospedale G.B. Morgagni, Forlì
Hospital de Basurto, Bilbao
Beaumont Health, Royal Oak
Hospital de Galdakao, Galdakao
A. O. Universitaria Careggi, Florence
Maharat Nakhonchiangmai Hospital, Muang
HOP Robert Debré, Reims
Institut Perubatan Respiratori, Kuala Lumpur
A.O.U. Senese, Siena
Universitätsklinikum Bonn AöR, Bonn
University of Wisconsin, Madison
Minnesota Lung Center and Sleep Institute, Edina
University of Minnesota, Minneapolis
Mayo Clinic, Rochester, Rochester
Lungenklinik Hemer, Hemer
INS Coeur Poumon, Lille
Ospedali Riuniti di Ancona, Torrette Di Ancona (Ancona)
Evanston Hospital Pulmonary Clinic, Evanston
The Lung Research Center, LLC, Chesterfield
Washington University School of Medicine, St Louis
Centro de Prevención y Rehabilitación de Enfermedades Pulmon, Monterrey
University of Kansas Medical Center, Kansas City
HOP Civil, Strasbourg
Oaxaca Site Management Organization, S.C., Oaxaca City
Creighton University, Omaha
University of Nebraska Medical Center, Omaha
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg, Heidelberg
HOP Louis Pradel, Bron
Tulane University Hospital and Clinic, New Orleans
Robert-Bosch-Krankenhaus GmbH, Stuttgart
Ospedale Colonnello D Avanzo, Foggia
Hospital of Heraklion (PAGNI), Crete
Universitätsklinikum Tübingen, Tübingen
HOP Paris Saint-Joseph, Paris
Premier Pulmonary Critical Care and Sleep Medicine, Denison
HOP Tenon, Paris
Akademiska sjukhuset, Uppsala
HOP Bichat, Paris
HOP Charles Nicolle, Rouen
The University of Texas Health Science Center at Houston, Houston
UT Health San Antonio, San Antonio
Klinikum Konstanz, Konstanz
National Jewish Health, Denver
Klinikum der Universität München - Campus Großhadern, München
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City
University of Utah Health Sciences Center, Salt Lake City
Renown Regional Medical Center, Reno
University of Southern California, Los Angeles
Cedars-Sinai Medical Center, Los Angeles
University of California Los Angeles, Los Angeles
Songklanagarind Hospital, Hat Yai
Oulun yliopistollinen keskussairaala, Oulu
Klinikum Nürnberg, Nuremberg
HOP Foch, Suresnes
HOP Avicenne, Bobigny
Sarawak General Hospital, Kuching
HOP Bicêtre, Le Kremlin-Bicêtre
A.O.U. Policlinico Vittorio Emanuele, Catania
University of California Davis, Sacramento
CIMS Studienzentrum Bamberg GmbH, Bamberg
The Oregon Clinic, Portland
Virginia Mason Medical Center, Seattle
China-Japan Friendship Hospital, Beijing
Peking Union Medical College Hospital, Beijing
Chinese PLA General Hospital, Beijing
China Shenyang Chest Hospital, Shenyang
National University Hospital-Singapore-42005, Singapore
Singapore General Hospital, Singapore
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
Shanghai Chest Hospital, Shanghai
Zhongshan Hospital Affiliated to Fudan University, Shanghai
Huadong Hospital affiliated to Fudan University, Shanghai
Shanghai Pulmonary Hospital, Shanghai
Nanjing Drum Tower Hospital, Nanjing
Wuxi People's Hospital, Wuxi
The First Affiliated Hospital of Soochow University, Suzhou
Affiliated Hospital, Xuzhou Medical college, Xuzhou
Anhui Provincial Hospital, Hefei
Tan Tock Seng Hospital, Singapore
Hangzhou First People's Hospital, Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou
The First hospital of Jiaxing, Jiaxing
The First Affiliated Hospital of Ningbo University, Ningbo
Jinhua Municipal Central Hospital, Jinhua
The Second Xiangya Hospital Of Central South University, Changsha
Wuhan Union Hospital, Wuhan
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T, Wuhan
Renmin Hospital of Wuhan University, Wuhan
Yichang Central People's Hospital, Yichang
First Affiliated Hospital of Guangzhou Medical University, Guangzhou
NanFang Hosptial, Guangzhou
Shenzhen People's Hospital, Shenzhen
The University of Hong Kong-Shenzhen Hospital, Shenzhen
People's Hospital of Sichuan Province, Sichuan
West China Hospital of Sichuan University, Chengdu
Second Affiliated Hospital of Xi'an JiaoTong University, Xi'an
Centro de Investigación del Maule, Talca
Instituto Nacional del Tórax, Providencia, Santiago de Chile
Serviços Medicos Respirar Sul Fluminense, Barra Mansa
Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMG), Belo Horizonte,Minas Gerais
Yale University School of Medicine, New Haven
Massachusetts General Hospital, Boston
Brigham and Women's Hospital, Boston
St. Elizabeth's Medical Center, Boston
Infinity Medical Research, North Dartmouth
University of Michigan Health System, Ann Arbor
Dartmouth-Hitchcock Medical Center, Lebanon
CEDIC - Centro de Investigacion Clinica, CABA
Hospital Italiano de Buenos Aires, CABA
Consultorios Médicos del Buen Ayre, Capital Federal
INSARES, Mendoza
Centro Respiratorio de Quilmes, Quilmes
Hospital Elisabethinen Linz, Linz
Edumed - Educacao e Saude SA, Curitiba
CLARE - Clinica de Pneumologia, Goiânia
Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre
Instituto D´Or de Pesquisa e Ensino - Bahia, Salvador
CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo do Campo
Hospital Alemao Oswaldo Cruz, São Paulo
University of Alberta Hospital (University of Alberta), Edmonton
Kelowna Respirology & Allergy Research, Kelowna
Vancouver General Hospital, Vancouver
St. Paul's Hospital (Vancouver), Vancouver
Dr. Georges-L.-Dumont University Hospital Centre, Moncton
QEII Health Sciences Centre, Halifax
St. Joseph's Healthcare Hamilton, Hamilton
Dr. Syed Anees Medicine Professional Corporation, Windsor
Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal
McGill University Health Centre (MUHC), Montreal
CIC Mauricie Inc., Trois-Rivières
IUCPQ (Laval University), Québec
HYKS Keuhkosairauksien tutkimusyksikkö, Helsinki
HOP d'Angers, Angers
HOP Pasteur, Nice
Klinikum Chemnitz gGmbH, Chemnitz
Fachkrankenhaus Coswig GmbH, Coswig
Univ. Gen. Hosp. of Ioannina, Ioannina
Connolly Hospital Blanchardstown, Dublin
Pol. Universitario Tor Vergata, Roma
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma
Tosei General Hospital, Aichi, Seto
Fujita Health University Hospital, Aichi, Toyoake
Chiba University Hospital, Chiba, Chiba
IUHW Narita Hospital, Chiba, Narita
University of Fukui Hospital, Fukui, Yoshida-gun
National Hospital Organization Kyushu Medical Center, Fukuoka, Fukuoka
Kyushu University Hospital, Fukuoka, Fukuoka
Aso Co.,Ltd Iizuka Hospital, Fukuoka, Iizuka
Kurume University Hospital, Fukuoka, Kurume
Fukushima Medical University Hospital, Fukushima, Fukushima
Tsuboi Hospital, Fukushima, Koriyama
Hiroshima Prefectural Hospital, Hiroshima, Hiroshima
Sapporo Medical University Hospital, Hokkaido, Sapporo
National Hospital Organization Himeji Medical Center, Hyogo, Himeji
Kobe City Medical Center General Hospital, Hyogo, Kobe
Kobe City Hospital Organization Kobe City Medical Center West Hospital, Hyogo, Kobe
Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Yokohama
Saiseikai Kumamoto Hospital, Kumamoto, Kumamoto
Nagasaki University Hospital, Nagasaki, Nagasaki
Kindai University Hospital, Osaka, Osakasayama
National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Sakai
Saitama Red Cross Hospital, Saitama, Saitama
Shimane University Hospital, Shimane, Izumo
Hamamatsu University Hospital, Shizuoka, Hamamatsu
Jichi Medical University Hospital, Tochigi, Shimotsuke
Tokushima University Hospital, Tokushima, Tokushima
Juntendo University Hospital, Tokyo, Bunkyo-ku
Toranomon Hospital, Tokyo, Minato-ku
Kyorin University Hospital, Tokyo, Mitaka
Toho University Omori Medical Center, Tokyo, Ota-ku
Tokyo Medical University Hospital, Tokyo, Shinjuku-ku
National Center for Global Health and Medicine, Tokyo, Shinjuku-ku
Wakayama Medical University Hospital, Wakayama, Wakayama
Soltmed Smo, Mexico City
Zuyderland Medisch Centrum, Heerlen
St. Antonius ziekenhuis, locatie Nieuwegein, Nieuwegein
Erasmus Medisch Centrum-ROTTERDAM-50697, Rotterdam
Haukeland Universitetssykehus, Bergen
Oslo Universitetssykehus HF, Rikshospitalet, Oslo
University Clinical Center, Gdansk, Gdansk
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa, Warsaw
ULS de Coimbra, E.P.E., Coimbra
USLM, EPE - Hospital Pedro Hispano, Matosinhos Municipality
Allianze Pulmonary Research LLC, Guaynabo
Kyung Hee University Hospital, Seoul
Seoul National University Hospital, Seoul
Severance Hospital, Seoul
Soonchunhyang University Hospital Seoul, Seoul
Asan Medical Center, Seoul
Samsung Medical Center, Seoul
Hospital General Universitario de Alicante, Alicante
Hospital del Mar, Barcelona
Hospital Universitari Vall D Hebron, Barcelona
Hospital Clínic de Barcelona, Barcelona
Hospital de Bellvitge, L'Hospitalet de Llobregat
Hospital Son Espases, Palma de Mallorca
Universitetssjukhuset, Linköping, Linköping
Sahlgrenska Universitetsjukhuset, Stockholm
Queen Elizabeth Hospital Birmingham, Birmingham
Southmead Hospital, Bristol
Royal Infirmary of Edinburgh, Edinburgh
Royal Devon and Exeter Hospital, Wonford, Exeter
Royal Lancaster Infirmary, Lancaster
St James's University Hospital, Leeds
Royal Brompton Hospital, London
Wythenshawe Hospital, Manchester
Churchill Hospital, Oxford
Lead Sponsor
Boehringer Ingelheim
INDUSTRY