Clinical trial NCT04552899: A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Official title: A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-09-17
Enrollment: 665
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline
* High-resolution computed tomography (HRCT) pattern consistent with the diagnosis of IPF, confirmed by central review of Chest HRCT and central review of any available lung biopsy (LB)
* Minimum 6 minute walk distance (6MWD) of 150 meters with maximum use of 6 L/min at sea-level and up-to 8 L/min at altitude of supplemental oxygen while maintaining oxygen saturation of greater than or equal to (\>/= )83% during the 6 minute walk test (6MWT) during screening
* FVC \>/= 45% predicted during screening as determined by the over-reader
* Forced expiratory volume in 1 second (FEV1)/FVC ratio greater than (\>) 0.70 during screening determined by the over-reader
* Diffusing capacity for carbon monoxide (DLCO) \>/= 30% and less than or equal to (\</=) 90% of predicted at screening as determined by the over-reader
* If receiving pirfenidone or nintedanib treatment for IPF, the participant must have been on treatment for at least 3 months and a stable dose for at least 4 weeks prior to screening, and during screening
* If not currently receiving nintedanib or pirfenidone treatment (either treatment naïve or having previously taken and discontinued) must have discontinued such treatment \>/= 4 weeks prior to screening and during screening
* Anticipated life expectancy of at least 12 months at baseline
* Participant and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study.
* For women of childbearing potential (excluding participant enrolling in Japan): agreement to remain abstinent or use contraception
* For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
* Anticipated life expectancy of at least 12 months at baseline, according to the investigator's judgment
* For participant enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry

Exclusion Criteria:

* Evidence of other known causes of Interstitial Lung Disease (ILD)
* FVC% predicted value showing repeated increase in the 6 months period prior to screening and including screening value
* Emphysema present on greater than or equal to (\>/=) 50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT
* Receiving nintedanib in combination with pirfenidone
* Received cytotoxic, immunosuppressive, cytokine modulating, or receptor antagonist agents (including but not limited to methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine or other steroid sparing agent) within 4 weeks prior to or during screening
* Receiving systemic corticosteroids equivalent to prednisone \> 10 mg/day or equivalent within 2 weeks prior to or during screening
* Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit
* Participants with active or latent tuberculosis (confirmed within the 6 months prior to or during screening, by a positive screening test \[interferon gamma release assay\])
* Resting oxygen saturation of \< 89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (\>/= 5000 feet \[1524 meters\] above sea level) during screening
* Class IV New York Heart Association chronic heart failure
* Historical evidence of left ventricular ejection fraction \< 35%
* Presence of pulmonary hypertension that, in the investigator's opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study
* Cardiopulmonary rehabilitation program based on exercise training that has been completed within 8 weeks prior to screening or planned to start during the participant enrollment in this trial
* History of smoking, alcohol or substance abuse disorder, or a malignancy
* Previous treatment with PRM-151
* Clinically significant abnormality on ECG during screening that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant including prolonged corrected QT interval \> 450 ms (for men) or \> 470 ms (for women) on ECG during screening based on the Fridericia correction formula
* Clinically significant laboratory test abnormalities during screening (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant
* Pregnant or breastfeeding, or become pregnant during the study or within 8 weeks after the final dose of PRM-151
* Women of childbearing potential (Only for participants enrolling in Japan)

Primary outcomes:
measure: Absolute Change in Forced Vital Capacity (FVC [mL])
timeFrame: From Baseline up to Week 52
Secondary outcomes:
measure: Absolute Change in 6-minute Walk Distance (6MWD)
timeFrame: From Baseline up to Week 52
measure: Absolute Change in FVC% Predicted
timeFrame: From Baseline up to Week 52
measure: Time to Disease Progression
timeFrame: From Baseline up to 1 year
measure: Time to First Respiratory-related Hospitalizations
timeFrame: From Baseline up to 1 year
measure: Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)
timeFrame: At Baseline, Week 12, Week 24, Week 36 and Week 52
measure: Change in St. George Respiratory Questionnaire (SGRQ) Total Score
timeFrame: At Baseline, Week 12, Week 24, Week 36 and Week 52
measure: Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)
timeFrame: From Baseline up to 1 year
measure: Change in Carbon Monoxide Diffusing Capacity (DLCO)
timeFrame: At Baseline, Week 12, Week 24, Week 36 and Week 52
measure: Survival
timeFrame: From Baseline up to 1 year
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
measure: Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest
timeFrame: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
measure: Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs
timeFrame: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
measure: Plasma Concentrations of PRM-151
timeFrame: Days 1, 5 and Weeks 4, 12, and 24
measure: Prevalence of Anti-drug Antibodies (ADAs) at Baseline
timeFrame: At Baseline
measure: Percentage of Participants With ADAs During the Study
timeFrame: Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix; Main Pharmacy
state: Arizona
city: Phoenix
country: United States
facility: Lovelace Scientific Resources, Inc.
state: Arizona
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: San Diego
country: United States
facility: Inst. of Healthcare Assessment, Inc.
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: San Juan Capistrano
country: United States
facility: Paloma Medical Group
state: California
city: Santa Barbara
country: United States
facility: William Sansum Diabetes Center
state: California
city: Aurora
country: United States
facility: University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
state: Colorado
city: Denver
country: United States
facility: National Jewish Health Medical Center
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Brandon
country: United States
facility: Meris Clinical Research
state: Florida
city: Celebration
country: United States
facility: Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
state: Florida
city: Daytona Beach
country: United States
facility: Advanced Pulmonary & Sleep Research Institute of Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine
state: Florida
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Pulmonology - Jacksonville
state: Florida
city: Loxahatchee Groves
country: United States
facility: Advanced Pulmonary Research Institute
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, PA
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System; Cancer Research Program
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Weston
country: United States
facility: Integral ? Clinical Trial Solutions
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Austell
country: United States
facility: Piedmont Healthcare Pulmonary and Critical Care Research
state: Georgia
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ School of Med
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics; Investigational Drug Services
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Health Sciences Center
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women'S Hospital
state: Massachusetts
city: Saginaw
country: United States
facility: Covenant Medical Center - Cooper
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Chesterfield
country: United States
facility: The Lung Research Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Summit
country: United States
facility: Pulmonary & Allergy Associates
state: New Jersey
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Charlotte
country: United States
facility: American Health Research Inc.
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Pulmonix Research
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Institute
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Jefferson University Physicians (JUP) - Jefferson Pulmonary
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina Hospital
state: South Carolina
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: North Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Cypress
country: United States
facility: Horizon Clinical Research Group
state: Texas
city: Dallas
country: United States
facility: Cardiopulmonary Research Science and Technology Institute
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center; Heart and Lung Clinic
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch; Cardiology Department
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonology & Sleep Center
state: Texas
city: San Antonio
country: United States
facility: Audie L. Murphy VA Hospital, STVHCS
state: Texas
city: Salt Lake City
country: United States
facility: University Of Utah Hosp & Clin; Investigational Pharmacy
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Hospital/IHVI; Cardiology
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Fundacion Respirar (Centro Medico Dra. De Salvo)
city: Córdoba
country: Argentina
facility: Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility
city: Florida, Buenos Aires
country: Argentina
facility: Centro Medico de Enfermedades Respiratorias (CEMER)
city: Mar Del Plata
country: Argentina
facility: Centro de estudios respiratorios
city: Mendoza, Mendoza City
country: Argentina
facility: INSARES
city: Mendoza
country: Argentina
facility: Fundacion Scherbovsky
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones en Patologias Respiratorias
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Cairns
country: Australia
facility: Cairns Base Hospital; Cancer Care Centre
state: Queensland
city: Nundah
country: Australia
facility: Lung Research Queensland
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Austin Hospital; Cancer Clinical Trials Centre
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre; Medicine
state: Victoria
city: Prahan
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie
city: Brussels
country: Belgium
facility: ULB Hôpital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc; Pharmacy
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: C. H. U. Sart-Tilman; Laboratory
city: Yvoir
country: Belgium
facility: CHU UCL Namur / site Godinne
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas - UFMG
state: MG
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
state: RS
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Sherwood Park
country: Canada
facility: Synergy Respiratory Care
state: Alberta
city: Kelowna
country: Canada
facility: Kelowna Respiratory and Allergy Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital; Gordon and Leslie Diamond Health Care
state: British Columbia
city: St. John's
country: Canada
facility: Eastern Health - General Hospital
state: Newfoundland and Labrador
city: Owen Sound
country: Canada
facility: The Rhema Research Institute
state: Ontario
city: Windsor
country: Canada
facility: Dr. Syed Anees Medicine Profession Corporation
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital
state: Quebec
city: Montreal
country: Canada
facility: McGill University, Montreal Chest Institute; Viral and other Infectious
state: Quebec
city: Trois-Rivières
country: Canada
facility: C.I.C. Mauricie
state: Quebec
city: Beijing City
country: China
facility: CMU-Beijing Chao-Yang Hospital-Beijing Institute of Respiratory Medicine
city: Beijing City
country: China
facility: China-Japan Friendship Hospital
city: Beijing City
country: China
facility: Peking Union Medical College Hospital; Pharmacy
city: Beijing Shi
country: China
facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changsha City
country: China
facility: Xiangya Hospital Central South University
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Changsha
country: China
facility: The Third Xiangya Hospital Of Central South University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Guangdong Province Guangzhou City
country: China
facility: Southern Medical University Nanfang Hospital
city: Guangzhou City
country: China
facility: The First Affilicated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Hangzhou City
country: China
facility: 1st Affiliated Hospital of Zhejiang University; Clinical Trial Pharmacy
city: Hohhot City
country: China
facility: Inner Mongolia Autonomous Region People's Hospital
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Nanchang City
country: China
facility: The 1st Affiliated Hospital of Nanchang Unversity
city: Nanjing City
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
city: Ningbo City
country: China
facility: Ningbo First Hospital
city: Shanghai City
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shenyang City
country: China
facility: China Medical University (CMU) First Affiliated Hospital
city: ShenYang
country: China
facility: Shengjing Hospital of China Medical University
city: Shijiazhuang City
country: China
facility: Hebei Medical University - The Second Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan City
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xi'an City
country: China
facility: Tangdu Hospital, The Fourth Military Medical University; Neurology Department
city: Xining City
country: China
facility: Qinghai Provincial People?s Hospital
city: Zhengzhou City
country: China
facility: Henan University of Traditional Chinese Medicine (HUTCM) The First Affiliated Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Plzen
country: Czechia
facility: Fakultni Nemocnice Plzen - Klinika Pneumologie a Ftizeologie
city: Prague
country: Czechia
facility: Nemocnice Na Bulovce
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice; Lekarna - pavilon H
city: Zlín
country: Czechia
facility: Krajská nemocnice T. Bati, a. s.
city: Aarthus N
country: Denmark
facility: Aarhus Universitetshospital Skejby
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Bobigny
country: France
facility: Hopital Avicenne
city: Brest
country: France
facility: Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche
city: Bron
country: France
facility: Hopital Louis Pradel
city: Clamart
country: France
facility: Hospital d Instructions des Armees Percy
city: Dijon
country: France
facility: CHU Dijon Bourgogne Hôpital François Mitterand
city: La Tronche
country: France
facility: CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille
city: Marseille
country: France
facility: Servie de Pneumologie et centre de Transplantation Pulmonaire
city: Montpellier
country: France
facility: CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique
city: Nice
country: France
facility: CHU Nice - Hôpital Pasteur 2
city: Paris
country: France
facility: Hopital Bichat Claude Bernard; CIC
city: Paris
country: France
facility: European Hospital Georges Pompidou (HEGP)
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Reims
country: France
facility: Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche
city: Rennes
country: France
facility: CHU de Rennes - Hopital de Pontchaillo
city: Tours
country: France
facility: CHU Tours - Hôpital Bretonneau; Pharmacie
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH; Pneumologie
city: Berlin
country: Germany
facility: Evang. Lungenklinik Berlin Klinik für Pneumologie
city: Essen
country: Germany
facility: Universitatsklinikum Essen; Innere Klinik
city: Frankfurt am Main
country: Germany
facility: IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie
city: Gießen
country: Germany
facility: Universitatsklinikum Gießen und Marburg GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover; Zentrum Innere Medizin - Klinik fur Pneumologie
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig; Apotheke
city: Mainz
country: Germany
facility: IKF Pneumologie Mainz Helix Medical Excellence Center Mainz
city: Marburg
country: Germany
facility: Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup
city: Münnerstadt
country: Germany
facility: Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken
city: Solingen
country: Germany
facility: Krankenhaus Bethanien gGmbH
city: Athens
country: Greece
facility: Evangelismos Hospital; Department of Critical Care and Pulmonary Services
city: Chaidari
country: Greece
facility: Attikon University General Hospital
city: Heraklio
country: Greece
facility: University General Hospital of Heraklion
city: Ioannina
country: Greece
facility: University Hospital of Ioannina; Pulmonology Department
city: Larissa
country: Greece
facility: Hospital is University General Hospital of Larissa
city: Marousi
country: Greece
facility: Athens Medical Center
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Sotiria Athens
country: Greece
facility: General hospital of Chest Diseases "Sotiria", 7th Pulmonary Clinic 
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki G. Papanikolaou
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong; Queen Mary Hospital
city: Budapest
country: Hungary
facility: Semmelweis University
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
city: Tatabánya
country: Hungary
facility: Szent Borbala Korhaz
city: Törökbálint
country: Hungary
facility: Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum
city: Ashkelon
country: Israel
facility: Barzilai Medical Center; Neurology Department
city: Be'er Ya'akov
country: Israel
facility: Shamir medical center
city: Beer sheva
country: Israel
facility: Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Bnai Zion Medical Center; Internal Medicine
city: Haifa
country: Israel
facility: Carmel Medical Center; Obstetrics and Gynecology
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center; Nrphrology Dept.
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Kfar- Saba
country: Israel
facility: Meir Medical Center
city: Petach Tiqwa
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center; Department of Pulmonary
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
state: Abruzzo
city: Napoli
country: Italy
facility: AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera Dei Colli
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
state: Campania
city: Napoli
country: Italy
facility: Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche
state: Campania
city: Forlì
country: Italy
facility: Ospedale Morgagni Pierantoni; Patologia clinica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
state: Emilia-Romagna
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Trieste
state: Friuli-Venezia Giulia
city: Rome
country: Italy
facility: Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio
state: Lazio
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia
state: Lazio
city: Garbagnate Milanese
country: Italy
facility: Asst Rhodense - Unità operativa di pneumologia Ospedale "Guido Salvini" 
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Giuseppe; U.O. di Pneumologia
state: Lombardia
city: Milano
country: Italy
facility: Asst Santi Paolo E Carlo
state: Lombardia
city: Monza
country: Italy
facility: Ospedale San Gerardo
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia
state: Lombardia
city: Torrette Di Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti
state: Marche
city: Orbassano (to)
country: Italy
facility: A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone
state: Piemonte
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette
state: Piemonte
city: Foggia
country: Italy
facility: Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia
state: Puglia
city: Ostuni
country: Italy
facility: Ospedale di Ostuni - Pneumologia
state: Puglia
city: Sassari
country: Italy
facility: A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale
state: Sardegna
city: Catania
country: Italy
facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
state: Sicilia
city: Palermo
country: Italy
facility: Az. Osp. Univ. P. Giaccone; UOC di Pneumologia
state: Sicilia
city: Palermo
country: Italy
facility: Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia
state: Sicilia
city: Firenze
country: Italy
facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
state: Toscana
city: Siena
country: Italy
facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche
state: Toscana
city: Padova
country: Italy
facility: Azienda Ospedale Università Di Padova; Clinica Pneumologica
state: Veneto
city: Treviso
country: Italy
facility: University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center
state: Veneto
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital
city: Hyogo
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Kamogawa
country: Japan
facility: Kameda Medical Center
city: Kanagawa
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Kawasaki-Shi
country: Japan
facility: Nippon Medical School Musashi Kosugi Hospital
city: Kumamoto-Shi
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Naka-gun
country: Japan
facility: National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research
city: Okayama
country: Japan
facility: Kurashiki Central Hospital
city: Sakai-shi
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Seto-shi
country: Japan
facility: Tosei General Hospital
city: Tenri-Shi
country: Japan
facility: Tenri Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Bucheon-si,
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon St. Mary's Hospital
city: Namdong-gu
country: Korea, Republic of
facility: Gacheon University Gil Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital (SNUH) - Medical Oncology Center
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary?s Hospital
city: Ciudad de México
country: Mexico
facility: INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
state: Mexico CITY (federal District)
city: Mexico
country: Mexico
facility: Centro Respiratorio de México
state: Mexico CITY (federal District)
city: San Nicolás de Los Garza
country: Mexico
facility: Unidad Médica para la Salud Integral UMSI
state: Nuevo LEON
city: Chihuahua
country: Mexico
facility: Unidad de Investigacion CIMA SC
city: Morelia
country: Mexico
facility: CICC Morelia
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Ziekenhuis, locatie Nieuwegein
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: NZ Respiratory & Sleep Institute
city: Christchurch
country: New Zealand
facility: University of Otago, Christchurch
city: Hamilton
country: New Zealand
facility: Waikato Hospital; Gastro Research
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Bergen
country: Norway
facility: Helse Bergen HF Haukeland universitetssykehus
city: Lørenskog
country: Norway
facility: Akershus universitetssykehus
city: Oslo
country: Norway
facility: Oslo University Hospital HF, Rikshospitalet
city: Bia?ystok
country: Poland
facility: Centrum Medycyny Oddechowej Mroz sp. j.
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii
city: Braga
country: Portugal
facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
city: Faro
country: Portugal
facility: Centro Hospitalar Algarve
city: Guimaraes
country: Portugal
facility: Hospital Senhora da Oliveira ? Guimarães, E.P.E
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo António
city: Porto
country: Portugal
facility: Hospital de Sao Joao; Centro de Investigacao
city: Porto
country: Portugal
facility: Hospital de Santa Luzia
city: Vila Nova de Gaia
country: Portugal
facility: CHVNG/E_Unidade 1; Servico de Pneumologia
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital; Oncology
city: Cape Town
country: South Africa
facility: University of Cape Town Lung Institute; Lung Clinical Research
city: Somerset West
country: South Africa
facility: Vergelegen Medi-Clinic
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Txagorritxu
state: Alava
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Sabadell
country: Spain
facility: Parc Taulí Sabadell Hospital Universitari
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario
state: LA Coruña
city: Coslada
country: Spain
facility: Hospital Universitario del Henares
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
state: Madrid
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Pamplona
country: Spain
facility: Universidad de Navarra - Clinica Universitaria de Navarra (CUN)
state: Navarra
city: S. Cristobal De La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia
city: Barcelona
country: Spain
facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves; Servicio de Neumologia
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra ? Madrid
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal;Servicio de Neumología
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz.
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova (Valencia)
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Malmö
country: Sweden
facility: Skånes universitetssjukhus Malmö
city: Bern
country: Switzerland
facility: Inselspital Bern Universitätsklinik für Pneumologie
city: Neuchâtel
country: Switzerland
facility: Hopital Neuchatelois Pourtales (Hopitaux Cadolles Pourtales)
city: Chia-yi
country: Taiwan
facility: Buddhist Tzu Chi Dalin General Hospital; Rheumatology
city: Kaoshiung City
country: Taiwan
facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital; Department of Clinical Pathology
city: Xitun Dist.
country: Taiwan
facility: Veterans General Hospital - Taichung
city: ?stanbul
country: Turkey
facility: Istanbul Universitesi Onkoloji Enstitüsü Hastanesi
city: Adana
country: Turkey
facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
city: Bursa
country: Turkey
facility: Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi - Sahinbey Arastirma ve Uygulama Hastanesi
city: Istanbul
country: Turkey
facility: Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
city: Izmir
country: Turkey
facility: Dokuz Eylul University Faculty of Medicine; Chest Diseases
city: Kayseri
country: Turkey
facility: Erciyes Üniversitesi T?p Fakültesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi
city: Maltepe
country: Turkey
facility: Marmara Universitesi Hastanesi Marmara University Hospital
city: Mersin
country: Turkey
facility: Mersin Üniversitesi Tip Fakültesi
city: Muratpasa/Antalya
country: Turkey
facility: Akdeniz University Faculty of Medicine Department of Pulmonology
city: Sariyer
country: Turkey
facility: Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
city: Dnipro
country: Ukraine
facility: Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council
state: Katerynoslav Governorate
city: Kyiv
country: Ukraine
facility: National Academy of Medical Science of Ukraine (NAMS); NRCRM
state: KIEV Governorate
city: Kyiv
country: Ukraine
facility: Yanovskyy Inst of Phth. & Pulm; Clinical-functional
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Infirmary; Respiratory Department
city: London
country: United Kingdom
facility: Royal Brompton Hospital; Respiratory Department
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust - Wythenshawe Hospital
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: