Phase
Condition
Pulmonary Fibrosis
Cystic Fibrosis
Lung Injury
Treatment
Placebo matching BI 1819479
BI 1819479
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients ≥40 years old at the time of signed informed consent.
Signed and dated written informed consent in accordance with ICH-GCP and locallegislation prior to admission to the trial.
Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
On stable treatment with nintedanib or pirfenidone for at least 12 weeks or not ontreatment with either nintedanib or pirfenidone for at least 12 weeks
Forced Vital Capacity (FVC) ≥45% of predicted normal.
Diffusion capacity of the lung for carbon monoxide (DLCO) ≥25% of predicted normalcorrected for hemoglobin (Hb).
Women of childbearing potential (WOCBP) must use highly effective methods of birthcontrol with low user dependency and additional barrier contraception for malepartners (use of condom) until end of follow-up period.
Male trial participants with WOCBP partners must use contraception (condom) to avoidexposure via seminal fluid. Female partners of male trial participants must usehighly effective methods of contraception during treatment until end of follow-upperiod.
Exclusion
Exclusion Criteria:
Acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) within at least 12 weeksprior to screening and/or during the screening period (investigator-determined).
Treated with immunosuppressive medications (other than oral corticosteroids) orprednisone >15 mg/day or equivalent for respiratory or pulmonary reasons.
Patients who must or wish to continue the intake of restricted medications or anydrug considered likely to interfere with the safe conduct of the trial.
The patient is currently enrolled in another investigational device or drug trial,or their Visit 1 occurs less than 30 days or 5 half-lives (whichever is longer)after completing a previous investigational device or drug trial or receiving otherinvestigational treatments.
Patients with a significant disease or condition other than the IPF under study,which in the opinion of the investigator, may put the patient at risk because ofparticipation, interfere with trial procedures, or cause concern regarding thepatient's ability to participate in the trial or any medical condition which couldlead to a life expectancy <12 months.
Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1second (FEV1)/forced vital capacity (FVC) <0.7).
In the opinion of the Investigator, other clinically significant pulmonaryabnormalities.
Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
Further exclusion criteria apply.
Study Design
Connect with a study center
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
C.a.b.a, C1027AAP
ArgentinaActive - Recruiting
CEDIC - Centro de Investigacion Clinica
Caba, C1060ABN
ArgentinaActive - Recruiting
Centro de Investigación Clinica Belgrano
Caba, 1425
ArgentinaActive - Recruiting
Hospital Britanico de Buenos Aires
Caba, 1280AEB
ArgentinaActive - Recruiting
Consultorios Médicos del Buen Ayre
Capital Federal, 1425
ArgentinaActive - Recruiting
Canberra Hospital
Garran, Australian Capital Territory 2605
AustraliaSite Not Available
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
Launceston Respiratory & Sleep Centre
Launceston, Tasmania 7250
AustraliaSite Not Available
Lung Research Victoria
Footscray, Victoria 3011
AustraliaActive - Recruiting
Austin Hospital
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Institute for Respiratory Health
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Macquarie University
Macquarie Park, 2109
AustraliaActive - Recruiting
Medical University of Graz State Hospital - University Hospital Graz
Graz, 8036
AustriaActive - Recruiting
Krems University Hospital
Krems, 3500
AustriaActive - Recruiting
Hospital Elisabethinen Linz
Linz,
AustriaActive - Recruiting
Kepler Univ. Klinikum Linz
Linz, 4020
AustriaSite Not Available
Clinic Floridsdorf
Vienna, 1210
AustriaActive - Recruiting
Klinik Penzing SMZ Baumgartner Hoehe
Vienna, 1140
AustriaActive - Recruiting
Standort Penzing der Klinik Ottakring
Vienna, 1140
AustriaActive - Recruiting
Klinikum Wels - Grieskirchen GmbH
Wels, 4600
AustriaActive - Recruiting
Brussels - UNIV Saint-Luc
Bruxelles, 1200
BelgiumActive - Recruiting
Centre Hospitalier Universitaire de Liège
Liège, 4000
BelgiumSite Not Available
Liège - HOSP CHR de la Citadelle
Liège, 4000
BelgiumActive - Recruiting
Serviços Medicos Respirar Sul Fluminense
Barra Mansa, 27323240
BrazilActive - Recruiting
Faculdade de Medicina de Botucatu - UNESP
Botucatu, 18618-687
BrazilSite Not Available
Hospital das Clínicas da UFG - EBSERH
Goiania, 74605-050
BrazilActive - Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90035-074
BrazilActive - Recruiting
COE Sao Jose dos Campos
SJC, 122241-660
BrazilSite Not Available
Pesquisare
Santo André, 09080-110
BrazilActive - Recruiting
Hospital Alemao Oswaldo Cruz
Sao Paulo, 01327-001
BrazilSite Not Available
University of Calgary
Calgary, Alberta T2N 4Z6
CanadaActive - Recruiting
QEII Health Sciences Centre
Halifax, Nova Scotia B3H 3A7
CanadaActive - Recruiting
Toronto General Hospital
Toronto, Ontario M5G 2N2
CanadaActive - Recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
Beijing Chao-Yang Hospital
Beijing, 100020
ChinaCompleted
The Second Xiangya Hospital Of Central South University
Changsha, 410011
ChinaSite Not Available
People's Hospital of Sichuan Province
Chengdu, 610072
ChinaSite Not Available
West China Hospital
Chengdu, 610041
ChinaSite Not Available
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
ChinaCompleted
Hangzhou First People's Hospital
Hangzhou, 310006
ChinaCompleted
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016
ChinaSite Not Available
Zhejiang Hospital
Hangzhou, 310013
ChinaCompleted
Anhui Provincial Hospital
Hefei, 230001
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing, 210008
ChinaSite Not Available
Shanghai Chest Hospital
Shanghai, 200030
ChinaSite Not Available
Shanghai Pulmonary Hospital
Shanghai, 200433
ChinaSite Not Available
China Shenyang Chest Hospital
Shenyang, 110000
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, 30052
ChinaCompleted
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430022
ChinaSite Not Available
Affiliated Hospital, Xuzhou Medical college
Xuzhou, 221009
ChinaSite Not Available
Thomayer University Hospital
Prague, 140 59
CzechiaActive - Recruiting
University Hospital Bulovka
Prague, 18081
CzechiaSite Not Available
Rigshospitalet-København Ø-69883
København Ø, 2100
DenmarkActive - Recruiting
Odense University Hospital
Odense, 5000
DenmarkActive - Recruiting
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, 00029
FinlandActive - Recruiting
Oulun yliopistollinen keskussairaala
Oulu, 90220
FinlandActive - Recruiting
Tampereen yliopistollinen sairaala
Tampere, 33520
FinlandActive - Recruiting
TYKS
Turku, 20520
FinlandActive - Recruiting
HOP d'Angers
Angers, 49933
FranceActive - Recruiting
HOP Avicenne
Bobigny, 93000
FranceSite Not Available
HOP Louis Pradel
Bron, 69677
FranceActive - Recruiting
HOP CHU Caen
Caen, 14033
FranceActive - Recruiting
HOP Côte de Nacre
Caen, 14033
FranceActive - Recruiting
INS Coeur Poumon
Lille, 59037
FranceActive - Recruiting
HOP Nord
Marseille, 13915
FranceActive - Recruiting
HOP Nord-Marseille-61673
Marseille, 13915
FranceSite Not Available
HOP Pasteur
Nice, 06001
FranceActive - Recruiting
HOP Pontchaillou
Rennes, 35033
FranceActive - Recruiting
HOP Charles Nicolle
Rouen, 76031
FranceSite Not Available
Pneumologische Praxis Dr. Löh
Bad Homburg, 61350
GermanySite Not Available
Charite Universitätsmedizin Berlin KöR
Berlin, 10117
GermanySite Not Available
Charité - Universitätsmedizin Berlin
Berlin, 10117
GermanySite Not Available
Universitätsklinikum Bonn AöR
Bonn, 53127
GermanyActive - Recruiting
Caritas-Krankenhaus St. Maria gGmbH
Donaustauf, 99093
GermanyActive - Recruiting
Klinikum Fulda gAG
Fulda, 36043
GermanyActive - Recruiting
Universitätsmedizin Greifswald
Greifswald, 17475
GermanyActive - Recruiting
Klinikum Region Hannover GmbH
Hannover, 30459
GermanyActive - Recruiting
Lungenklinik Hemer
Hemer, 58675
GermanySite Not Available
Lungenfachklinik Immenhausen
Immenhausen, 34376
GermanyActive - Recruiting
Klinikum Konstanz
Konstanz, 78464
GermanyActive - Recruiting
Universität Leipzig
Leipzig, 04103
GermanyActive - Recruiting
Klinikum der Universität München AÖR
München, 81377
GermanyActive - Recruiting
Univ. Gen. Hosp. of Ioannina
Ioannina, 45 500
GreeceSite Not Available
Univ. Gen. Hosp. of Patras
Patras, 26504
GreeceSite Not Available
Hospital of Heraklion (PAGNI)
Voutes, 71500
GreeceActive - Recruiting
Koranyi National Institute For Pulmonolgy
Budapest, 1121
HungarySite Not Available
University of Debrecen Clinical Centre
Debrecen, 4032
HungaryActive - Recruiting
A. O. Universitaria Careggi
Firenze, 50137
ItalyActive - Recruiting
Ospedale Colonnello D Avanzo
Foggia, 71100
ItalySite Not Available
Ospedale G.B. Morgagni
Forli', 47121
ItalySite Not Available
Ospedale G.B. Morgagni - L. Pierantoni AUSL Forlì
Forli', 47121
ItalySite Not Available
Azienda Ospedaliera San Martino
Genova, 16132
ItalyActive - Recruiting
Osp. S. Giuseppe Fatebenefratelli
Milano, 20123
ItalyActive - Recruiting
Ospedale Classificato San Giuseppe
Milano, 20123
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
ItalyActive - Recruiting
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, 00189
ItalySite Not Available
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
ItalySite Not Available
Pol. Universitario Tor Vergata
Roma, 00133
ItalyActive - Recruiting
Poli Univ A. Gemelli
Roma, 00168
ItalySite Not Available
Tosei General Hospital
Aichi, Seto, 489-8642
JapanSite Not Available
University of Fukui Hospital
Fukui, Yoshida-gun, 910-1193
JapanActive - Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
JapanActive - Recruiting
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563
JapanActive - Recruiting
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051
JapanActive - Recruiting
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555
JapanActive - Recruiting
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192
JapanActive - Recruiting
Tokushima University Hospital
Tokushima, Tokushima, 770-8503
JapanActive - Recruiting
Kyorin University Hospital
Tokyo, Mitaka, 181-8611
JapanActive - Recruiting
Toho University Omori Medical Center
Tokyo, Ota-ku, 143-8541
JapanActive - Recruiting
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655
JapanSite Not Available
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655
JapanSite Not Available
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon, 14647
Korea, Republic ofActive - Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Inje University Sanggye Paik Hospital
Seoul, 01757
Korea, Republic ofCompleted
Kyung Hee University Hospital
Seoul, 02447
Korea, Republic ofActive - Recruiting
Severance Hospital
Seoul, 03722
Korea, Republic ofActive - Recruiting
Soonchunhyang University Hospital Seoul
Seoul, 04401
Korea, Republic ofActive - Recruiting
Hospital Sultan Idris Shah Serdang
Kajang, 43000
MalaysiaSite Not Available
Institut Perubatan Respiratori
Kuala Lumpur, 53000
MalaysiaActive - Recruiting
Sarawak General Hospital
Kuching, Sarawak, 93586
MalaysiaSite Not Available
Waikato Hospital
Hamilton, 3240
New ZealandActive - Recruiting
Greenlane Clinical Centre
One Tree Hill, Auckland, 1051
New ZealandActive - Recruiting
Middlemore Clinical Trials
Papatoetoe, 2025
New ZealandSite Not Available
Haukeland Universitetssykehus
Bergen, N-5021
NorwayActive - Recruiting
Akershus Universitetssykehus HF
Lørenskog, 1478
NorwayActive - Recruiting
University Clinical Hospital in Bialystok I
Bialystok, 15-540
PolandSite Not Available
Norbert Barlicki University Clinical Hospital No.1, Lodz
Lodz, 90-153
PolandSite Not Available
Clin.Hosp.Med.Univ.Marcinkowski in Poznan
Poznan, 60-569
PolandActive - Recruiting
Alergopneuma Medical Center
Swidnik, 21040
PolandActive - Recruiting
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warsaw, 01-138
PolandSite Not Available
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warszawa, 01-138
PolandSite Not Available
Singapore General Hospital
Singapore, 169608
SingaporeActive - Recruiting
Tan Tock Seng Hospital
Singapore, 308433
SingaporeActive - Recruiting
Hospital General Universitario de Alicante
Alicante, 03010
SpainActive - Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Vall d'Hebron-Barcelona-47683
Barcelona, 08035
SpainActive - Recruiting
Hospital de Galdakao
Galdakao, 48960
SpainActive - Recruiting
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907
SpainActive - Recruiting
Hospital La Princesa
Madrid, 28006
SpainActive - Recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
SpainActive - Recruiting
Hospital Virgen de la Victoria
Malaga, 29010
SpainActive - Recruiting
Hospital Central de Asturias
Oviedo, 33011
SpainActive - Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, 39008
SpainActive - Recruiting
Hospital Clínico de Santiago
Santiago de Compostela, 15706
SpainActive - Recruiting
Hospital Virgen del Rocío
Sevilla, 41013
SpainActive - Recruiting
Karolinska University Hospital
Stockholm, 171 76
SwedenActive - Recruiting
CTC Clinical Trial Consultants AB
Uppsala, 752 37
SwedenActive - Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, 83301
TaiwanSite Not Available
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 807
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung, 40705
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 10002
TaiwanActive - Recruiting
Chang Gung Memorial Hospital(Linkou)
TaoYuan, 333
TaiwanActive - Recruiting
Chulalongkorn Hospital
Bangkok, 10330
ThailandActive - Recruiting
Songklanagarind Hospital
Hat Yai, 90110
ThailandActive - Recruiting
Srinagarind Hospital
Khon Kaen, 40002
ThailandActive - Recruiting
Ramathibodi Hospital
Ratchathewi, 10400
ThailandActive - Recruiting
Heartlands Hospital
Birmingham, B9 5SS
United KingdomActive - Recruiting
Castle Hill Hospital
Cottingham, Hull, HU16 5JQ
United KingdomActive - Recruiting
Royal Devon and Exeter Hospital
Exeter, EX2 5DW
United KingdomSite Not Available
Royal Devon and Exeter Hospital, Wonford
Exeter, EX2 5DW
United KingdomActive - Recruiting
Royal Lancaster Infirmary
Lancaster, LA1 4RP
United KingdomActive - Recruiting
St James's University Hospital
Leeds, LS9 7TF
United KingdomActive - Recruiting
Royal Brompton Hospital
London, SW3 6NP
United KingdomActive - Recruiting
Wythenshawe Hospital
Manchester, M23 9LT
United KingdomActive - Recruiting
Churchill Hospital
Oxford, OX3 7LJ
United KingdomActive - Recruiting
Southampton General Hospital
Southampton, SO16 6YD
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesActive - Recruiting
The Medical Research Group
Fresno, California 93720
United StatesSite Not Available
Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado 80228
United StatesSite Not Available
St. Francis Medical Institute
Clearwater, Florida 33765
United StatesSite Not Available
Clinical Research Specialists LLC
Kissimmee, Florida 34746
United StatesActive - Recruiting
SEC Clinical Research
Pensacola, Florida 32503
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
The Iowa Clinic, PC
West Des Moines, Iowa 50266
United StatesActive - Recruiting
Advanced Pulmonary Research
Warren, Michigan 48088
United StatesActive - Recruiting
Memorial Hospital Gulfport
Gulfport, Mississippi 39501
United StatesActive - Recruiting
Singing River Health
Ocean Springs, Mississippi 39564
United StatesSite Not Available
Renown Regional Medical Center
Reno, Nevada 89502
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
New Bern, North Carolina 28562
United StatesActive - Recruiting
Southeastern Research Center
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
Clinical Research Associates of Central PA
DuBois, Pennsylvania 15801
United StatesActive - Recruiting
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Lowcountry Lung and Critical Care
Charleston, South Carolina 29406
United StatesActive - Recruiting
Spartanburg Medical Research
Spartanburg, South Carolina 29303
United StatesSite Not Available
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee 37067
United StatesActive - Recruiting
University of Utah Health Sciences Center
Salt Lake City, Utah 84132
United StatesSite Not Available
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia 23230
United StatesSite Not Available
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