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A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BI 1015550
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 local legislation prior to admission to the trial.
  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)

  • Patients may be either:

    • on a stable therapy* with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. Combination of nintedanib plus pirfenidone is not allowed. (*stable therapy is defined as the individually and general tolerated regimen of either nintedanib or pirfenidone (no dose changes) for at least 12 weeks.)
    • not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
  • Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.
  • Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) corrected for Haemoglobin (Hb) [Visit 1] ≥25% and <90% predicted of normal at Visit 1.
  • Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control. Of note, oral hormonal contraceptives are not considered a highly effective method due to potential drug-drug interactions.

Exclusion criteria

  1. Relevant airways obstruction (prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) <0.7) at Visit 1.
  2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
  3. Acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
  4. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
  5. Confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) not fully recovered according to investigator judgement within the 4 weeks prior to randomization (Visit 2).
  6. Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery.
  7. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  8. Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) >2.5 x Upper limit of normal (ULN) or total Bilirubin >1.5 x ULN at Visit 1.

Further exclusion criteria apply.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Southern California
  • Cedars-Sinai Medical Center
  • University of California Los Angeles
  • University of California Davis
  • National Jewish Health
  • Yale University School of Medicine
  • Christiana Hospital
  • Georgetown University
  • St. Francis Medical Institute
  • University of Florida Health Shands Hospital
  • Clinical Research Specialists LLC
  • Advanced Pulmonary Research Institute
  • Destin Pulmonary Critical Care
  • Piedmont Healthcare
  • Evanston Hospital Pulmonary Clinic
  • University of Kansas Medical Center
  • Louisville Pulmonary Care
  • Tulane University Hospital and Clinic
  • Johns Hopkins Hospital
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • St. Elizabeth's Medical Center
  • Infinity Medical Research
  • University of Michigan Health System
  • Beaumont Health
  • Minnesota Lung Center and Sleep Institute
  • University of Minnesota
  • Mayo Clinic, Rochester
  • The Lung Research Center, LLC
  • Washington University School of Medicine
  • Creighton University
  • University of Nebraska Medical Center
  • Renown Regional Medical Center
  • Dartmouth-Hitchcock Medical Center
  • Stony Brook University Medical Center
  • Columbia University Medical Center-New York Presbyterian Hospital
  • Weill Cornell Medicine
  • Lenox Hill Hospital
  • Duke University Medical Center
  • Southeastern Research Center
  • University of Cincinnati
  • Cleveland Clinic
  • The Ohio State University Wexner Medical Center
  • The Oregon Clinic
  • University of Pennsylvania
  • Thomas Jefferson University
  • Temple University Hospital
  • Allegheny General Hospital
  • Infinity Medical Research, Inc.
  • Lowcountry Lung and Critical Care
  • Clinical Trials Center of Middle Tennessee, LLC
  • Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
  • Premier Pulmonary Critical Care and Sleep Medicine
  • The University of Texas Health Science Center at Houston
  • UT Health San Antonio
  • University of Utah Health Sciences Center
  • Virginia Mason Medical Center
  • University of Wisconsin
  • Medical College Of Wisconsin
  • Consultorios Médicos del Buen Ayre
  • Centro de Investigaciones Metabólicas (CINME)
  • CEDIC - Centro de Investigacion Clinica
  • Hospital Italiano de Buenos Aires
  • Instituto Ave Pulmo
  • INSARES
  • Centro Respiratorio de Quilmes
  • Canberra Hospital
  • Royal Prince Alfred Hospital
  • Westmead Hospital
  • Lung Research Queensland
  • The Prince Charles Hospital
  • Mater Hospital Brisbane
  • Princess Alexandra Hospital
  • Lung Research Victoria
  • Austin Hospital
  • The Alfred Hospital
  • Fiona Stanley Hospital
  • Trialswest
  • LKH Klagenfurt am Woerthersee
  • Krems University Hospital
  • Ordensklinikum Linz GmbH Elisabethinen
  • LKH Salzburg University Hospital
  • Clinic Floridsdorf
  • Klinikum Wels - Grieskirchen GmbH
  • Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
  • ULB Hopital Erasme
  • Brussels - UNIV Saint-Luc
  • UNIV UZ Gent
  • UZ Leuven
  • Centre Hospitalier Universitaire de Liège
  • Yvoir - UNIV UCL de Mont-Godinne
  • Serviços Medicos Respirar Sul Fluminense
  • Hospital das Clinicas da Universidade Federal HC-UFMG
  • Edumed - Educacao e Saude SA
  • CLARE - Clinica de Pneumologia
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Hospital Alemao Oswaldo Cruz
  • CEMEC - Centro Multidisciplinar de Estudos Clínicos
  • University of Alberta Hospital (University of Alberta)
  • Kelowna Respirology & Allergy Research
  • Vancouver General Hospital
  • St. Paul's Hospital
  • Dr. Georges-L.-Dumont University Hospital Centre
  • QEII Health Sciences Centre
  • St. Joseph's Healthcare Hamilton
  • Dr. Syed Anees Medicine Professional Corporation
  • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • McGill University Health Centre (MUHC)
  • CIC Mauricie Inc.
  • IUCPQ (Laval University)
  • Instituto Nacional del Tórax
  • Centro de Investigación del Maule
  • China-Japan Friendship Hospital
  • Peking Union Medical College Hospital
  • Chinese PLA General Hospital
  • The Second Xiangya Hospital Of Central South University
  • West China Hospital
  • First Affiliated Hospital of Guangzhou Medical University
  • NanFang Hosptial
  • Hangzhou First People's Hospital
  • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • Anhui Provincial Hospital
  • The First hospital of Jiaxing
  • Jinhua Municipal Central Hospital
  • Nanjing Drum Tower Hospital
  • Ningbo Medical Center Lihuili Hospital
  • Ningbo First Hospital
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Chest Hospital
  • Zhongshan Hospital Fudan University
  • Shanghai Huadong Hospital
  • Shanghai Pulmonary Hospital
  • China Shenyang Chest Hospital
  • Shenzhen People's Hospital
  • The University of Hong Kong-Shenzhen Hospital
  • People's Hospital of Sichuan Province
  • The First Affiliated Hospital of Soochow University
  • Tianjin Medical University General Hospital
  • Wuhan Union Hospital
  • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
  • Renmin Hospital of Wuhan University
  • Wuxi People's Hospital
  • Second Affiliated Hospital of Xi'an JiaoTong University
  • Affiliated Hospital, Xuzhou Medical college
  • Yichang NO.1 People's Hospital
  • Yuncheng Central Hospital
  • University Hospital Dubrava
  • Aarhus University Hospital
  • Herlev and Gentofte Hospital
  • Odense University Hospital
  • East Tallinn Central Hospital
  • North Estonia Medical Centre Foundation, Tallinn
  • HYKS Keuhkosairauksien tutkimusyksikkö
  • Oulun yliopistollinen keskussairaala
  • HOP d'Angers
  • HOP Avicenne
  • HOP de la Cavale Blanche
  • HOP Louis Pradel
  • HOP Côte de Nacre
  • HOP François Mitterrand
  • HOP Michallon
  • HOP Bicêtre
  • HOP Calmette
  • HOP Nord
  • HOP Nord Laennec
  • HOP Pasteur
  • HOP Paris Saint-Joseph
  • HOP Tenon
  • HOP Bichat
  • HOP Haut-Lévêque
  • HOP Maison Blanche
  • HOP Pontchaillou
  • HOP Charles Nicolle
  • HOP Civil
  • HOP Foch
  • HOP Larrey
  • HOP Bretonneau
  • CIMS Studienzentrum Bamberg GmbH
  • Vivantes Netzwerk für Gesundheit GmbH
  • Universitätsklinikum Bonn AöR
  • Klinikum Chemnitz gGmbH
  • Fachkrankenhaus Coswig GmbH
  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
  • Universitätsklinikum Hamburg-Eppendorf
  • Klinikum Region Hannover GmbH
  • Medizinische Hochschule Hannover
  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
  • Lungenklinik Hemer
  • Lungenfachklinik Immenhausen
  • Klinikum Konstanz
  • Klinikum der Universität München - Campus Großhadern
  • Klinikum Nürnberg
  • Krankenhaus Bethanien gGmbH
  • Helios Hanseklinikum Stralsund
  • Robert-Bosch-Krankenhaus GmbH
  • Universitätsklinikum Tübingen
  • Petrus-Krankenhaus
  • Univ. Gen. Hosp. of Ioannina
  • Univ. Gen. Hosp. of Patras
  • Hospital of Heraklion (PAGNI)
  • Koranyi National Institute For Pulmonolgy
  • University of Debrecen Clinical Centre
  • Connolly Hospital Blanchardstown
  • A.O.U. Policlinico Vittorio Emanuele
  • A. O. Universitaria Careggi
  • Ospedale Colonnello D Avanzo
  • Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
  • Osp. S. Giuseppe Fatebenefratelli
  • Azienda Ospedaliera Policlinico di Modena
  • Azienda Ospedaliera Universitaria di Padova
  • Pol. Universitario Tor Vergata
  • Poli Univ A. Gemelli
  • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Ospedali Riuniti di Ancona
  • Tosei General Hospital
  • Fujita Health University Hospital
  • Chiba University Hospital
  • IUHW Narita Hospital
  • University of Fukui Hospital
  • National Hospital Organization Kyushu Medical Center
  • Kyushu University Hospital
  • Aso Co.,Ltd Iizuka Hospital
  • Kurume University Hospital
  • Fukushima Medical University Hospital
  • Tsuboi Hospital
  • Hiroshima Prefectural Hospital
  • Sapporo Medical University Hospital
  • National Hospital Organization Himeji Medical Center
  • Kobe City Medical Center General Hospital
  • Kobe City Hospital Organization Kobe City Medical Center West Hospital
  • Kanagawa Cardiovascular and Respiratory Center
  • Saiseikai Kumamoto Hospital
  • Nagasaki University Hospital
  • Kindai University Hospital
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Saitama Red Cross Hospital
  • Shimane University Hospital
  • Hamamatsu University Hospital
  • Jichi Medical University Hospital
  • Tokushima University Hospital
  • Juntendo University Hospital
  • Toranomon Hospital
  • Kyorin University Hospital
  • Toho University Omori Medical Center
  • Tokyo Medical University Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • Wakayama Medical University Hospital
  • The Catholic University of Korea, Bucheon St.Mary's Hospital
  • Seoul National University Bundang Hospital
  • Kyung Hee University Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • Soonchunhyang University Hospital Seoul
  • Asan Medical Center
  • Samsung Medical Center
  • Hospital Serdang
  • Institut Perubatan Respiratori
  • Sarawak General Hospital
  • Hospital Pulau Pinang
  • Centro de Investigacion Integral MEDIVEST S.C
  • Soltmed Smo S.C.
  • Centro Respiratorio de Mexico
  • Centro de Prevención y Rehabilitación de Enfermedades Pulmon
  • Oaxaca Site Management Organization, S.C.
  • Zuyderland Medisch Centrum
  • St. Antonius ziekenhuis, locatie Nieuwegein
  • Erasmus Medisch Centrum
  • Waikato Hospital
  • Greenlane Clinical Centre
  • Middlemore Clinical Trials
  • Tauranga Hospital
  • Haukeland Universitetssykehus
  • Akershus Universitetssykehus HF
  • Oslo Universitetssykehus HF, Rikshospitalet
  • University Clinical Center, Gdansk
  • Alergopneuma Medical Center
  • Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
  • USLM, EPE - Hospital Pedro Hispano
  • CardioPulmonary Research
  • University Clinical Center Nis
  • National University Hospital
  • Singapore General Hospital
  • Tan Tock Seng Hospital
  • Busamed Paardevlei Private Hospital
  • Melomed Gatesville Hospital
  • KwaPhila Health Solutions
  • Hospital General Universitario de Alicante
  • Hospital del Mar
  • Hospital Vall d'Hebron
  • Hospital Clínic de Barcelona
  • Hospital de Basurto
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital de Galdakao
  • Hospital Universitari de Girona Doctor Josep Trueta
  • Hospital Universitario Virgen de las Nieves
  • Hospital de Bellvitge
  • Hospital Universitario Lucus Augusti
  • Hospital La Princesa
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario Infanta Leonor
  • Hospital Ramón y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Virgen de la Victoria
  • Hospital Central de Asturias
  • Hospital Son Espases
  • Hospital Quirónsalud Madrid
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Clínico de Santiago
  • Hospital Virgen del Rocío
  • Hospital Nuestra Señora de Valme
  • Hospital General Universitario de Valencia
  • Universitetssjukhuset, Linköping
  • Akademiska sjukhuset
  • University Hospital Basel
  • Hopitaux Universitaires de Geneve (HUG)
  • Chang-Hua Christian Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • Far Eastern Memorial Hospital
  • Taichung Veterans General Hospital
  • NCKUH
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Siriraj Hospital
  • Songklanagarind Hospital
  • Srinagarind Hospital
  • Central Chest Institute of Thailand
  • Maharat Nakhonchiangmai Hospital
  • Ramathibodi Hospital
  • Queen Elizabeth Hospital
  • Southmead Hospital
  • Royal Papworth Hospital
  • Royal Infirmary of Edinburgh
  • Royal Devon and Exeter Hospital
  • Royal Lancaster Infirmary
  • St James's University Hospital
  • Guy's Hospital
  • Royal Brompton Hospital
  • Wythenshawe Hospital
  • Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BI 1015550 low dose

BI 1015550 high dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52

Secondary Outcome Measures

Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial
Key secondary endpoint
Time to first acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation or death over the duration of trial
Time to hospitalization for respiratory cause or death over the duration of trial
Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial
Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial
Time to death over the duration of trial
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52
The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52
The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52
The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.
Absolute change from baseline in FVC % predicted at Week 52
Absolute change from baseline in DLCO % predicted at Week 52

Full Information

First Posted
April 4, 2022
Last Updated
October 17, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05321069
Brief Title
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
Official Title
A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
August 5, 2024 (Anticipated)
Study Completion Date
November 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 1015550 low dose
Arm Type
Experimental
Arm Title
BI 1015550 high dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BI 1015550
Intervention Description
BI 1015550
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52
Time Frame
at baseline, at week 52
Secondary Outcome Measure Information:
Title
Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial
Description
Key secondary endpoint
Time Frame
up to 30 months
Title
Time to first acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation or death over the duration of trial
Time Frame
up to 30 months
Title
Time to hospitalization for respiratory cause or death over the duration of trial
Time Frame
up to 30 months
Title
Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trial
Time Frame
up to 30 months
Title
Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial
Time Frame
up to 30 months
Title
Time to death over the duration of trial
Time Frame
up to 30 months
Title
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52
Description
The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.
Time Frame
at baseline, at week 52
Title
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52
Description
The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.
Time Frame
at baseline, at week 52
Title
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52
Description
The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items). The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score. Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.
Time Frame
at baseline, at week 52
Title
Absolute change from baseline in FVC % predicted at Week 52
Time Frame
at baseline, at week 52
Title
Absolute change from baseline in DLCO % predicted at Week 52
Time Frame
at baseline, at week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 local legislation prior to admission to the trial. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) Patients may be either: on a stable therapy* with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. Combination of nintedanib plus pirfenidone is not allowed. (*stable therapy is defined as the individually and general tolerated regimen of either nintedanib or pirfenidone (no dose changes) for at least 12 weeks.) not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment. Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1. Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1 Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method Exclusion criteria Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) <0.7 at Visit 1 In the opinion of the Investigator, other clinically significant pulmonary abnormalities. Acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined). Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis. Confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) not fully recovered according to investigator judgement within the 4 weeks prior to randomization (Visit 2). Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix. Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) >2.5 x Upper limit of normal (ULN) or total Bilirubin >1.5 x ULN at Visit 1. Further exclusion criteria apply.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
St. Francis Medical Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
University of Florida Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Clinical Research Specialists LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34746
Country
United States
Facility Name
Advanced Pulmonary Research Institute
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Destin Pulmonary Critical Care
City
Santa Rosa Beach
State/Province
Florida
ZIP/Postal Code
32459
Country
United States
Facility Name
Piedmont Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Evanston Hospital Pulmonary Clinic
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Louisville Pulmonary Care
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Infinity Medical Research
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5314
Country
United States
Facility Name
Beaumont Health
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Minnesota Lung Center and Sleep Institute
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic, Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Lung Research Center, LLC
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Stony Brook University Medical Center
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Columbia University Medical Center-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Infinity Medical Research, Inc.
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Lowcountry Lung and Critical Care
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Clinical Trials Center of Middle Tennessee, LLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Premier Pulmonary Critical Care and Sleep Medicine
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College Of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Consultorios Médicos del Buen Ayre
City
Buenos Aires
ZIP/Postal Code
C1425FVH
Country
Argentina
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
C.a.b.a
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
CEDIC - Centro de Investigacion Clinica
City
Caba
ZIP/Postal Code
C1060ABN
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Caba
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Instituto Ave Pulmo
City
Mar del Plata
ZIP/Postal Code
7600
Country
Argentina
Facility Name
INSARES
City
Mendoza
ZIP/Postal Code
M5500CCG
Country
Argentina
Facility Name
Centro Respiratorio de Quilmes
City
Quilmes
ZIP/Postal Code
B1878FNR
Country
Argentina
Facility Name
Canberra Hospital
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Lung Research Queensland
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Mater Hospital Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Lung Research Victoria
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Trialswest
City
Spearwood
State/Province
Western Australia
ZIP/Postal Code
6153
Country
Australia
Facility Name
LKH Klagenfurt am Woerthersee
City
Klagenfurt Am Woerthersee
ZIP/Postal Code
9020
Country
Austria
Facility Name
Krems University Hospital
City
Krems
ZIP/Postal Code
3500
Country
Austria
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
LKH Salzburg University Hospital
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Clinic Floridsdorf
City
Vienna
ZIP/Postal Code
1210
Country
Austria
Facility Name
Klinikum Wels - Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
ULB Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Brussels - UNIV Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UNIV UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Yvoir - UNIV UCL de Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Serviços Medicos Respirar Sul Fluminense
City
Barra Mansa
ZIP/Postal Code
27323240
Country
Brazil
Facility Name
Hospital das Clinicas da Universidade Federal HC-UFMG
City
Belo Horizonte,Minas Gerais
ZIP/Postal Code
31270901
Country
Brazil
Facility Name
Edumed - Educacao e Saude SA
City
Curitiba
ZIP/Postal Code
80440-080
Country
Brazil
Facility Name
CLARE - Clinica de Pneumologia
City
Goiania
ZIP/Postal Code
74110-030
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-074
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz
City
Sao Paulo
ZIP/Postal Code
01323-020
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos
City
São Bernardo do Campo
ZIP/Postal Code
09780-000
Country
Brazil
Facility Name
University of Alberta Hospital (University of Alberta)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
Kelowna Respirology & Allergy Research
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1W 1V3
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Dr. Georges-L.-Dumont University Hospital Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 2Z3
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Dr. Syed Anees Medicine Professional Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
McGill University Health Centre (MUHC)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CIC Mauricie Inc.
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
IUCPQ (Laval University)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Instituto Nacional del Tórax
City
Providencia, Santiago De Chile
ZIP/Postal Code
7500691
Country
Chile
Facility Name
Centro de Investigación del Maule
City
Talca
ZIP/Postal Code
3465586
Country
Chile
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
The Second Xiangya Hospital Of Central South University
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
West China Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
NanFang Hosptial
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
ZIP/Postal Code
310006
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
City
Hangzhou
ZIP/Postal Code
310018
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
The First hospital of Jiaxing
City
Jiaxing
ZIP/Postal Code
314000
Country
China
Facility Name
Jinhua Municipal Central Hospital
City
Jinhua
ZIP/Postal Code
321000
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Ningbo Medical Center Lihuili Hospital
City
Ningbo
ZIP/Postal Code
315000
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
ZIP/Postal Code
315010
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Huadong Hospital
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
China Shenyang Chest Hospital
City
Shenyang
ZIP/Postal Code
110000
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
ZIP/Postal Code
518020
Country
China
Facility Name
The University of Hong Kong-Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518053
Country
China
Facility Name
People's Hospital of Sichuan Province
City
Sichuan
ZIP/Postal Code
610031
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215006
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
30052
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
ZIP/Postal Code
214043
Country
China
Facility Name
Second Affiliated Hospital of Xi'an JiaoTong University
City
Xi'an
ZIP/Postal Code
710004
Country
China
Facility Name
Affiliated Hospital, Xuzhou Medical college
City
Xuzhou
ZIP/Postal Code
221009
Country
China
Facility Name
Yichang NO.1 People's Hospital
City
Yichang
ZIP/Postal Code
443000
Country
China
Facility Name
Yuncheng Central Hospital
City
Yuncheng
ZIP/Postal Code
044000
Country
China
Facility Name
University Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Herlev and Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation, Tallinn
City
Tallinn
ZIP/Postal Code
11619
Country
Estonia
Facility Name
HYKS Keuhkosairauksien tutkimusyksikkö
City
Helsinki
ZIP/Postal Code
000290
Country
Finland
Facility Name
Oulun yliopistollinen keskussairaala
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
HOP d'Angers
City
Angers
ZIP/Postal Code
49 933
Country
France
Facility Name
HOP Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
HOP de la Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
HOP Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
HOP Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
HOP François Mitterrand
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
HOP Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
HOP Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
HOP Calmette
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
HOP Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
HOP Nord Laennec
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
HOP Pasteur
City
Nice
ZIP/Postal Code
06001
Country
France
Facility Name
HOP Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
HOP Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
HOP Bichat
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
HOP Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
HOP Maison Blanche
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
HOP Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
HOP Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
HOP Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
HOP Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
HOP Larrey
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
HOP Bretonneau
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
CIMS Studienzentrum Bamberg GmbH
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Vivantes Netzwerk für Gesundheit GmbH
City
Berlin Neukölln
ZIP/Postal Code
12351
Country
Germany
Facility Name
Universitätsklinikum Bonn AöR
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
Fachkrankenhaus Coswig GmbH
City
Coswig
ZIP/Postal Code
01640
Country
Germany
Facility Name
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Klinikum Region Hannover GmbH
City
Hannover
ZIP/Postal Code
30459
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenklinik Hemer
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Lungenfachklinik Immenhausen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Klinikum Konstanz
City
Konstanz
ZIP/Postal Code
78464
Country
Germany
Facility Name
Klinikum der Universität München - Campus Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum Nürnberg
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Krankenhaus Bethanien gGmbH
City
Solingen
ZIP/Postal Code
42699
Country
Germany
Facility Name
Helios Hanseklinikum Stralsund
City
Stralsund
ZIP/Postal Code
18435
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus GmbH
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Petrus-Krankenhaus
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
Univ. Gen. Hosp. of Ioannina
City
Ioannina
ZIP/Postal Code
45 500
Country
Greece
Facility Name
Univ. Gen. Hosp. of Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Hospital of Heraklion (PAGNI)
City
Voutes
ZIP/Postal Code
71003
Country
Greece
Facility Name
Koranyi National Institute For Pulmonolgy
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
University of Debrecen Clinical Centre
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Connolly Hospital Blanchardstown
City
Dublin 15
ZIP/Postal Code
D15 X40D
Country
Ireland
Facility Name
A.O.U. Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
A. O. Universitaria Careggi
City
Firenze
ZIP/Postal Code
50100
Country
Italy
Facility Name
Ospedale Colonnello D Avanzo
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
City
Forli'
ZIP/Postal Code
47121
Country
Italy
Facility Name
Osp. S. Giuseppe Fatebenefratelli
City
Milano
ZIP/Postal Code
20123
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Pol. Universitario Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Poli Univ A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O.U. Senese Policlinico Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Ospedali Riuniti di Ancona
City
Torrette Di Ancona (Ancona)
ZIP/Postal Code
60126
Country
Italy
Facility Name
Tosei General Hospital
City
Aichi, Seto
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Fujita Health University Hospital
City
Aichi, Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba, Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
IUHW Narita Hospital
City
Chiba, Narita
ZIP/Postal Code
286-8520
Country
Japan
Facility Name
University of Fukui Hospital
City
Fukui, Yoshida-gun
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka, Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Aso Co.,Ltd Iizuka Hospital
City
Fukuoka, Iizuka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Kurume University Hospital
City
Fukuoka, Kurume
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima, Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Tsuboi Hospital
City
Fukushima, Koriyama
ZIP/Postal Code
963-0197
Country
Japan
Facility Name
Hiroshima Prefectural Hospital
City
Hiroshima, Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center
City
Hyogo, Himeji
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Hyogo, Kobe
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kobe City Hospital Organization Kobe City Medical Center West Hospital
City
Hyogo, Kobe
ZIP/Postal Code
653-0013
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Kanagawa, Yokohama
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto, Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki, Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka, Osakasayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Osaka, Sakai
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Saitama Red Cross Hospital
City
Saitama, Saitama
ZIP/Postal Code
330-8553
Country
Japan
Facility Name
Shimane University Hospital
City
Shimane, Izumo
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Shizuoka, Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Tochigi, Shimotsuke
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima, Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo, Minato-ku
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Kyorin University Hospital
City
Tokyo, Mitaka
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Tokyo, Ota-ku
ZIP/Postal Code
143-8541
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama, Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
The Catholic University of Korea, Bucheon St.Mary's Hospital
City
Bucheon
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital Seoul
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Hospital Serdang
City
Kajang
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Institut Perubatan Respiratori
City
Kuala Lumpur
ZIP/Postal Code
53000
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Centro de Investigacion Integral MEDIVEST S.C
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Soltmed Smo S.C.
City
Ciudad de Mexico
ZIP/Postal Code
03650
Country
Mexico
Facility Name
Centro Respiratorio de Mexico
City
Ciudad de Mexico
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Centro de Prevención y Rehabilitación de Enfermedades Pulmon
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Oaxaca Site Management Organization, S.C.
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
St. Antonius ziekenhuis, locatie Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Greenlane Clinical Centre
City
One Tree Hill, Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga South
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Haukeland Universitetssykehus
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
Facility Name
Akershus Universitetssykehus HF
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Oslo Universitetssykehus HF, Rikshospitalet
City
Oslo
ZIP/Postal Code
N-0372
Country
Norway
Facility Name
University Clinical Center, Gdansk
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Alergopneuma Medical Center
City
Swidnik
ZIP/Postal Code
21040
Country
Poland
Facility Name
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
City
Warsaw
ZIP/Postal Code
01-138
Country
Poland
Facility Name
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
USLM, EPE - Hospital Pedro Hispano
City
Matosinhos
ZIP/Postal Code
4454-509
Country
Portugal
Facility Name
CardioPulmonary Research
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
Facility Name
University Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Busamed Paardevlei Private Hospital
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Melomed Gatesville Hospital
City
Cape Town
ZIP/Postal Code
7764
Country
South Africa
Facility Name
KwaPhila Health Solutions
City
Durban
ZIP/Postal Code
4032
Country
South Africa
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital de Galdakao
City
Galdakao
ZIP/Postal Code
48960
Country
Spain
Facility Name
Hospital Universitari de Girona Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital de Bellvitge
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27004
Country
Spain
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Son Espases
City
Palma de Mallorca
ZIP/Postal Code
07120
Country
Spain
Facility Name
Hospital Quirónsalud Madrid
City
Pozuelo de Alarcón
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Clínico de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Nuestra Señora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Universitetssjukhuset, Linköping
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve (HUG)
City
Geneve
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Chang-Hua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
NCKUH
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10016
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Siriraj Hospital
City
Bangkok Noi
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Central Chest Institute of Thailand
City
Muang
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Maharat Nakhonchiangmai Hospital
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Ratchatewi
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Royal Papworth Hospital
City
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Royal Lancaster Infirmary
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
IPD Sharing Time Frame
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
https://www.mystudywindow.com
Description
Related Info

Learn more about this trial

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

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