Clinical trial NCT05595642: A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2022-10-27
Enrollment: 1290
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.


Eligibility criteria: Inclusion Criteria

* Documented COPD diagnosis for ≥ 12 months
* History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
* Post-bronchodilator FEV1 ≥ 20% and \< 80% of predicted at screening
* Post-bronchodilator FEV1/FVC \< 0.70 at screening
* Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
* Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
* On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
* Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD

Exclusion Criteria

* Current documented diagnosis of asthma
* History of clinically significant pulmonary disease other than COPD
* Diagnosis of 1-antitrypsin deficiency
* History of long-term treatment with oxygen at \> 4.0 liters/minute
* Lung volume reduction surgery or procedure within 12 months prior to screening
* Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
* History of lung transplant
* Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
* Upper or lower respiratory tract infection within 4 weeks prior to or during screening
* Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
* Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
* Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening

Primary outcomes:
measure: Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period
timeFrame: 52 weeks
Secondary outcomes:
measure: Time to first moderate or severe COPD exacerbation during the 52-week treatment period
timeFrame: 52 weeks
measure: Absolute change from baseline in health-related quality of life (HRQoL) at Week 52 as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score
timeFrame: Week 52
measure: Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52
timeFrame: Week 52
measure: Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52
timeFrame: Week 52
measure: Proportion of participants with improvement in HRQoL at Week 52
timeFrame: Week 52
measure: Annualized rate of severe COPD exacerbations over the 52-week treatment period
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Birmingham
country: United States
facility: AllerVie Clinical Research
state: Alabama
city: Birmingham
country: United States
facility: Synexus Clinical Research US, Inc. - Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Dothan
country: United States
facility: SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
state: Alabama
city: Glendale
country: United States
facility: Synexus Clinical Research US, Inc. - Phoenix West
state: Arizona
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Tucson
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Tucson
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of The Ozarks - ERN - PPDS
state: Arkansas
city: Bakersfield
country: United States
facility: Kern Research
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Vista
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Vista
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Medical Group of the Bay Area
state: California
city: Altamonte Springs
country: United States
facility: Cornerstone Research Institute
state: Florida
city: Coconut Creek
country: United States
facility: Invictus Clinical Research Group, LLC
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research Corporation
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research Corporation
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic Inc.
state: Florida
city: Miami
country: United States
facility: Oceane7 Medical & Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Avantis Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida Inc
state: Florida
city: Miami
country: United States
facility: Diverse Clinical Research, LLC
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, PA
state: Florida
city: Orlando
country: United States
facility: Revival Clinical Research
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Beach Clinical Research
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Health Care
state: Florida
city: The Villages
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - The Villages
state: Florida
city: Atlanta
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
state: Georgia
city: Columbus
country: United States
facility: Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPD
state: Georgia
city: Stonecrest
country: United States
facility: Pivotal Research Solutions
state: Georgia
city: Hammond
country: United States
facility: ASHA Clinical Research - ClinEdge - PPDS
state: Indiana
city: Lexington
country: United States
facility: The Research Group of Lexington, LLC
state: Kentucky
city: New Orleans
country: United States
facility: Best Clinical Trials
state: Louisiana
city: Bangor
country: United States
facility: Paul A. Shapero, MD, PA
state: Maine
city: Farmington Hills
country: United States
facility: Pulmonary Research Institute of Southeast Michigan
state: Michigan
city: Flint
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Lathrup Village
country: United States
facility: Revive Research Institute
state: Michigan
city: Troy
country: United States
facility: Oakland Medical Research Center
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Bellevue
country: United States
facility: Nebraska Medical Research Institute, Inc. - CRN
state: Nebraska
city: Las Vegas
country: United States
facility: The Machuca Foundation Inc
state: Nevada
city: Reno
country: United States
facility: Renown Regional Medical Center Hospital
state: Nevada
city: Marlton
country: United States
facility: Hassman Research Institute - HRI - Berlin - CenExel - PPDS
state: New Jersey
city: New York
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - New York
state: New York
city: Schenectady
country: United States
facility: WellNow Urgent Care and Clinical Research - Niskayuna
state: New York
city: Denver
country: United States
facility: Research Carolina Elite
state: North Carolina
city: Fayetteville
country: United States
facility: Care Access Research - Fayetteville - PPDS
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Greensboro
country: United States
facility: Pulmonix LLC
state: North Carolina
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine, PLLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Cincinnati
country: United States
facility: Wellnow Urgent Care and Research ? Springdale
state: Ohio
city: Huber Heights
country: United States
facility: WellNow Urgent Care & Research - Huber Heights
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute PC - CRN
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Altoona
country: United States
facility: Clinical Research Associates Of Central Pa , Llc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy & Clinical Immun Assoc
state: Pennsylvania
city: Columbia
country: United States
facility: Medtrial, LLC
state: South Carolina
city: Gaffney
country: United States
facility: Velocity Clinical Research - Gaffney - PPDS
state: South Carolina
city: Mauldin
country: United States
facility: Care Access Research - Mauldin - PPDS
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee
state: Tennessee
city: Hendersonville
country: United States
facility: Tennessee Comprehensive Lung & Sleep Center
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: Corsicana
country: United States
facility: Corsicana Medical Research
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: DeSoto
country: United States
facility: Epic Medical Research LLC - DeSoto
state: Texas
city: Houston
country: United States
facility: Greater Heights Memorial Pulmonary and Sleep
state: Texas
city: Houston
country: United States
facility: Trio Clinical Trials
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Medical Center
state: Texas
city: Houston
country: United States
facility: Uni of Texas Health Science Center At Houston
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic - Park Row - PPDS
state: Texas
city: Houston
country: United States
facility: Advances In Health Inc
state: Texas
city: Katy
country: United States
facility: R & H Clinical Research
state: Texas
city: Katy
country: United States
facility: R & H Clinical Research
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Everett
country: United States
facility: Western Washington Medical Group
state: Washington
city: Greenfield
country: United States
facility: Allergy Asthma and Sinus Center-Greenfield
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Consultorios Medicos Organizacion de Buen Ayre SRL
city: Buenos Aires
country: Argentina
facility: Fundacion Faicep
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Nexo Salud Investigacion Clinica - Riobamba 429
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: AES - AS - Glenny Corp. S.A. Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias
city: Concepcion Del Uruguay
country: Argentina
facility: Centro de Medicina Respiratoria
city: Cordoba
country: Argentina
facility: Sanatorio de la Canada
city: La Plata
country: Argentina
facility: Framingham Centro Medico
city: La Plata
country: Argentina
facility: Centro Medico Capital
city: La Plata
country: Argentina
facility: Centro Platense en Investigaciones Respiratorias
city: Mendoza
country: Argentina
facility: Centro Medico Dharma
city: Parana
country: Argentina
facility: Centro Privado de Medicina Respiratoria
city: Ranelagh, Berazategui
country: Argentina
facility: Sala de primeros auxilios Alberto Mignaburu
city: Rosario
country: Argentina
facility: Instituto Medico de la Fundacion Estudios Clinicos
city: Rosario
country: Argentina
facility: Servicio de Investigacion de Patologias Alergicas-Instituto ABC
city: Rosario
country: Argentina
facility: Sanatorio Parque de Rosario
city: San Miguel de Tucuman
country: Argentina
facility: Centro Modelo de Cardiologia
city: San Nicolas de los Arroyos
country: Argentina
facility: Centro Medico San Nicolas Grupo Orono
city: San Salvador
country: Argentina
facility: CEPROSS- Centro Profesional San Salvador
city: Santa Fe
country: Argentina
facility: Instituto Del Buen Aire
city: Santa Fe
country: Argentina
facility: Centro de Diagnostico Y Rehabilitacion
city: Midland
country: Australia
facility: Institute for Respiratory Health - Midland
state: South Australia
city: Feldbach
country: Austria
facility: Ordination Dr. Robert Voves
city: Linz
country: Austria
facility: Ordination fur Lungenkrankheiten
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Liège
country: Belgium
facility: CHU de Liège
city: Brasilia
country: Brazil
facility: L2IP ?Instituto de Pesquisas Clínicas Ltda.
state: Distrito Federal
city: Vitoria
country: Brazil
facility: CEDOES - Diagnóstico e Pesquisa
state: Espírito Santo
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte - PPDS
state: Minas Gerais
city: Passo Fundo
country: Brazil
facility: Instituto Méderi de Pesquisa e Saúde
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: LMK Servicos Medicos SS
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu
state: São Paulo
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC - FMABC
state: São Paulo
city: Sao Bernardo Do Campo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPCLIN Instituto Brasil de Pesquisa Clinica
city: São Paulo
country: Brazil
facility: Instituto do Coracao - HCFMUSP
city: Blagoevgrad
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Puls AD PPDS
city: Dimitrovgrad
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Sveta Ekaterina - Dimitrovgrad EOOD
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC
city: Montana
country: Bulgaria
facility: Medical Center Hera EOOD
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Plovdiv
city: Razgrad
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski- Razgrad AD
city: Shumen
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Shumen
city: Silistra
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Silistra AD
city: Smolyan
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
city: Sofia
country: Bulgaria
facility: Fifth Multiprofile Hospital for Active Treatment - Sofia EAD
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center Aleksandrovska EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic- Consultative Center Convex EOOD
city: Sofia
country: Bulgaria
facility: AES DRS Medical Center Synexus Sofia EOOD
city: Varna
country: Bulgaria
facility: Medical Center Researchexpert OOD
city: Veliko Tarnovo
country: Bulgaria
facility: Medical Center Tara OOD
city: Edmonton
country: Canada
facility: Edmonton Respiratory Consultants
state: Alberta
city: Edmonton
country: Canada
facility: Office of Irvin Mayers, MD
state: Alberta
city: Sherwood Park
country: Canada
facility: Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Ajax
country: Canada
facility: Dynamic Drug Advancement Ltd.
state: Ontario
city: Toronto
country: Canada
facility: Inspiration Research
state: Ontario
city: Windsor
country: Canada
facility: Dr. Syed Anees Medicine Profession Corporation
state: Ontario
city: Windsor
country: Canada
facility: Dr Anil Dhar Professional Medicine Corporation
state: Ontario
city: Montreal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Saint-charles-borromee
country: Canada
facility: Clinique de pneumologie et du sommeil de Lanaudiere
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier de l'Universite Laval
city: Pavie Gallegos
country: Chile
facility: Centro Respiratorio Integral LTDA. (CENRESIN)
city: Vina del Mar
country: Chile
facility: Oncocentro APYS
city: Vitacura
country: Chile
facility: Fundacion Medica San Cristobal
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Lianyungang
country: China
facility: The First People's Hospital of Lian Yun Gang
state: Jiangsu
city: Beijing City
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Beijing Chaoyang Hospital Capital Medical University
city: Beijing
country: China
facility: Beijing Jingmei Group General Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Peking University Shougang Hospital
city: Changchun City
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: The First Hospital of Changsha
city: Changsha
country: China
facility: The Third Hospital of Changsha
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
city: Chongqing City
country: China
facility: Army Medical Center of PLA(Daping Hospital)
city: Chongqing
country: China
facility: The Southwest Hospital of Army Medical University
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
city: Haikou
country: China
facility: Hainan General Hospital
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
city: Hefei City
country: China
facility: Anhui Chest Hospital
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Nantong
country: China
facility: Nantong First People's Hospital
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: ShenYang
country: China
facility: Shengjing Hospital of China Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Central Hospital of Wuhan
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Wuxi
country: China
facility: Jiangyin People's Hospital
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
city: Xian
country: China
facility: Xi'an International Medical Center Hospital
city: Xinxiang
country: China
facility: Xinxiang First People's Hospital
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
city: Yangzhou
country: China
facility: Yangzhou First People?s Hospital
city: Zhuhai City
country: China
facility: The Fifth Affiliated Hospital Sun Yat-Sen University
city: Zigong
country: China
facility: Zigong First People's Hospital
city: Brandys nad Labem-Stara Boleslav
country: Czechia
facility: Plicní ambulance MUDr. I. Cierná Peterová s.r.o.
city: Brno
country: Czechia
facility: Klinika nemoci plicnich a TBC FN Brno a LF MU - Ji
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Kyjov
country: Czechia
facility: Nemocnice Kyjov, prispevkova organizace
city: Opava
country: Czechia
facility: Odborna plicni ambulance Opava s.r.o
city: Praha 1
country: Czechia
facility: Ordinace chorob plicních s.r.o.
city: Praha
country: Czechia
facility: AES - DRS - Synexus Czech s.r.o.
city: Tabor
country: Czechia
facility: Nemocnice Tabor, a.s.
city: Teplice
country: Czechia
facility: Plicni stredisko Teplice s.r.o.
city: Næstved
country: Denmark
facility: Naestved Sygehus
city: Roskilde
country: Denmark
facility: Sjaellands Universitetshospital, Roskilde
city: Amiens
country: France
facility: Sas Clinique De L Europe - Amiens
city: Lille
country: France
facility: Hopital Calmette
city: Paris
country: France
facility: Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Vandoeuvre
country: France
facility: CHU de Nancy-Hopital Brabois Adulte
city: Lübeck
country: Germany
facility: Velocity Clinical Research Leipzig GmbH
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Praxis fur Kardiologie und Pneumologie Dr. med. Karin Forster
city: Berlin
country: Germany
facility: Studienpraxis Berlin-Brandenburg, Berlin
city: Berlin
country: Germany
facility: AES - DRS - Synexus Berlin Research Centre
city: Darmstadt
country: Germany
facility: Lungenzentrum Darmstadt
city: Frankfurt
country: Germany
facility: AES - DRS - Synexus Frankfurt Research Centre
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Clinical Research Hamburg
city: Hamburg
country: Germany
facility: ME Clinical Respiratory Research Hamburg GmbH
city: Hannover
country: Germany
facility: Pneumologicum
city: Heidelberg
country: Germany
facility: University Clinic Heidelberg
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Leipzig
country: Germany
facility: AES - DRS - Synexus Leipzig Research Centre
city: Leipzig
country: Germany
facility: BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
city: Magdeburg
country: Germany
facility: SMO.MD GmbH
city: München
country: Germany
facility: Praxis Dr. med. Jan Feimer
city: Neu-Isenburg
country: Germany
facility: Institut fur klinische Forschung GmbH
city: Rheine
country: Germany
facility: framol-med GmbH
city: Rosenheim
country: Germany
facility: Klinikum Rosenheim
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
city: Athina
country: Greece
facility: Navy Hospital of Athens
city: Heraklio
country: Greece
facility: University General Hospital of Heraklion
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Palaio Faliro
country: Greece
facility: Iatriko Palaiou Falirou
city: Thessaloniki
country: Greece
facility: Georgios Papanikolaou General Hospital of Thessaloniki
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.-Budapest
state: Pest
city: Csorna
country: Hungary
facility: Omnimodus Elixír Kft.
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet
city: Hyderabad
country: India
facility: Paarthiv Lung Care Center
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Yashoda Hospitals Hitec City
state: Andhra Pradesh
city: Srikakulam
country: India
facility: Government Medical College and Government General Hospital
state: Andhra Pradesh
city: New Delhi
country: India
facility: Aakash Healthcare Super Speciality Hospital
state: Delhi
city: Ahmadabad City
country: India
facility: GMERS Medical College and Hospital, Sola
state: Gujarat
city: Faridabad
country: India
facility: ESIC Medical College and Hospital - Faridabad
state: Haryana
city: Hubballi
country: India
facility: Karnataka Medical College and Research Institute, Hubballi;Department of Medicine
state: Karnataka
city: Nagpur
country: India
facility: Shree Hospital And Critical Care Centre
state: Maharashtra
city: Pune City
country: India
facility: Kothrud Hospital
state: Maharashtra
city: Jaipur
country: India
facility: Sawai Man Singh Hospital and Medical College
state: Rajasthan
city: Jaipur
country: India
facility: Maharaja Agrasen Super Speciality Hospital
state: Rajasthan
city: Aligarh
country: India
facility: Jawaharlal Nehru Medical College (JNMC)
state: Uttar Pradesh
city: Kanpur
country: India
facility: Apollo Spectra Hospital
state: Uttar Pradesh
city: Lucknow
country: India
facility: MV Hospital and Research Centre
state: Uttar Pradesh
city: Kolkata
country: India
facility: Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
state: WEST Bengal
city: Beer Sheva
country: Israel
facility: Soroka University Medical Centre
city: Haifa
country: Israel
facility: Rambam Medical Center - PPDS
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Kfar- Saba
country: Israel
facility: Meir Medical Center
city: Battipaglia
country: Italy
facility: Presidio Ospedaliero Santa Maria della Speranza
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera Dei Colli
state: Campania
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
state: Emilia-Romagna
city: Rome
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
state: Lazio
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
state: Lombardia
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga
state: Piemonte
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
state: Sicilia
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
state: Sicilia
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria Senese - Policlinico Santa Maria alle Scotte
state: Toscana
city: Ginowan-shi
country: Japan
facility: University of the Ryukyus Hospital
state: Okinawa
city: Aichi
country: Japan
facility: Nagoya Ekisaikai Hospital
city: Asahikawa-shi
country: Japan
facility: Asahikawa Medical Center
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital
city: Chuo-ku, Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Chuo
country: Japan
facility: Fukuwa Clinic
city: Fukuoka-Shi Nishi-Ku
country: Japan
facility: Nishi Fukuoka Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Himeji
country: Japan
facility: Terada Respiratory and Internal Clinic
city: Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital
city: Ishikawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
city: Joyo
country: Japan
facility: National Hospital Organization Minami Kyoto Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Medical Center
city: Kawachinagano-Shi
country: Japan
facility: Osaka-Minami Medical Center
city: Kiryu
country: Japan
facility: Kiryu Kosei General Hospital
city: Kishiwada
country: Japan
facility: Kishiwada City Hospital
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health,Japan
city: Koto
country: Japan
facility: Juntendo Tokyo Koto Geriatric Medical Center
city: Kumamoto-Shi
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Kyoto
country: Japan
facility: Rakuwakai Otowa Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization Kyoto Medical Center
city: Machida-shi
country: Japan
facility: Machida Municipal Hospital
city: Mibu-Machi
country: Japan
facility: Dokkyo Medical University Hospital
city: Mie
country: Japan
facility: Matsusaka City Hospital
city: Miyagi
country: Japan
facility: Fukushima Medical University Hospital
city: Nagoya-shi Minami-ku
country: Japan
facility: Kojunkai Social Medical Corporation Daido Clinic
city: Naka-gun
country: Japan
facility: National Hospital Organization Ibarakihigashi National Hospital
city: Niigata-shi
country: Japan
facility: Niigata City General Hospital
city: Oita
country: Japan
facility: Oita Medical Center
city: Okayama-Shi Minami-ku
country: Japan
facility: Okayama Rosai Hospital
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Omuta
country: Japan
facility: Omuta National Hospital
city: Sagamihara-shi Minami-ku
country: Japan
facility: National Hospital Organization - Sagamihara National Hospital
city: Sakai-shi
country: Japan
facility: NHO Kinki-Chuo Chest Medical Center
city: Sakaide
country: Japan
facility: Sakaide City Hospital
city: Sapporo-shi Chuo-ku
country: Japan
facility: Idaimae Minami 4-Jo Internal Medicine
city: Sapporo-shi
country: Japan
facility: Japan Community Health Care Organization Hokkaido Hospital
city: Shizuoka
country: Japan
facility: Shizuoka City Shizuoka Hospital
city: Shizuoka
country: Japan
facility: Iwata City Hospital
city: Takamatsu
country: Japan
facility: Kamei Internal Medicine and Respiratory Clinic
city: Takasaki
country: Japan
facility: National Hospital Organization Takasaki General Medical Center
city: Tanabe
country: Japan
facility: Minami Wakayama Medical Center
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
city: Tokyo
country: Japan
facility: Japanese Red Cross Medical Center
city: Toyama-Shi
country: Japan
facility: Toyama Prefectural Central Hospital
city: Yanagawa
country: Japan
facility: Nagata Hospital
city: Yokohama-shi Aoba-ku
country: Japan
facility: Showa University Fujigaoka Hospital
city: Yokohama-shi Kanazawa-ku
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Yokohama-Shi Totsuka-Ku
country: Japan
facility: National Hospital Organization - Yokohama Medical Center
city: Yonezawa
country: Japan
facility: Sanyudo Hospital
city: Kilifi
country: Kenya
facility: KEMRI-MTWAPA Clinical Trial Site
state: Coast
city: Machakos
country: Kenya
facility: Clinical Research Health Network (CREA-N)
city: Nairobi
country: Kenya
facility: KEMRI CRDR Clinical Research Clinic Nairobi
city: Nairobi
country: Kenya
facility: University of Nairobi Clinical Research Centre
city: Siaya
country: Kenya
facility: KEMRI/CRDR Siaya Clinical Research Annex
city: Thika
country: Kenya
facility: Center for Research In Tropical Medicine and community development
city: Bucheon-si,
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Wonju-Si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Daugavpils
country: Latvia
facility: Health Center Association, Medical Center OLVI
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: R?ga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga 1st Hospital
city: Riga
country: Latvia
facility: ConsiliumMedicum
city: Riga
country: Latvia
facility: Postgraduate Medical Training Institute University of Latvia
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum - Heerlen
city: Auckland
country: New Zealand
facility: Greenlane Clinical Centre
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Tauranga
country: New Zealand
facility: P3 Research
city: Waikanae Beach
country: New Zealand
facility: P3 Research - Kapiti - PPDS
city: Caloocan City
country: Philippines
facility: Manila Central University-Filemon D Tanchoco Medical Foundation
city: Dasmarinas
country: Philippines
facility: CARE CT Group Inc.
city: Iloilo City
country: Philippines
facility: Healthlink Medicalsurgicaldental Clinic and Diagnostic Center
city: Iloilo City
country: Philippines
facility: West Visayas State University Medical Center
city: Lipa City
country: Philippines
facility: Mary Mediatrix Medical Center
city: Quezon City
country: Philippines
facility: Philippine Heart Center
city: Quezon City
country: Philippines
facility: Quirino Memorial Medical Center
city: Lodz
country: Poland
facility: AppleTreeClinics Network Sp. z o.o.
state: Lódzkie
city: Bia?ystok
country: Poland
facility: Centrum Medycyny Oddechowej Mroz sp. j.
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj i Cichomski sp.j.
city: Bydgoszcz
country: Poland
facility: Medical Center Kermed
city: Chojnice
country: Poland
facility: Centrum Medyczne Lukamed Joanna Luka-Wendrowska
city: Czestochowa
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
city: Gda?sk
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
city: Grudzadz
country: Poland
facility: Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
city: Grudziadz
country: Poland
facility: Prywatny Gabinet Pulmonologiczny Joanna Nowacka-Apiyo
city: Katowice
country: Poland
facility: Centrum Medyczne Katowice - PRATIA - PPDS
city: Krakow
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
city: Ksawerów
country: Poland
facility: Prywatna Praktyka Lekarska Adam Smialowski
city: Lodz
country: Poland
facility: AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
city: Lublin
country: Poland
facility: Clinical Best Solutions - Lublin
city: Lublin
country: Poland
facility: NZOZ Przychodnia Alergologiczno-pulmonologiczna
city: Radom
country: Poland
facility: ABC-Pulmo NZOZ Agnieszka Dobielska, Jaroslaw Dobie
city: Slupsk
country: Poland
facility: NZOZ Poradnia Chorob Pluc i Alergologii
city: Sopot
country: Poland
facility: Centrum Medyczne KARDIOTEL
city: Sosnowiec
country: Poland
facility: Kiepury Clinic
city: Szczecin
country: Poland
facility: Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych Dorota Malosek
city: Tarnow
country: Poland
facility: CenterMed Bandrowskiego
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun
city: Trzebnica
country: Poland
facility: Viltis Medica Specjalistyczna Praktyka Lekarska Lek. Med. Agata Kot
city: Warszawa
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Wroc?aw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
city: Wroc?aw
country: Poland
facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
city: Wroc?aw
country: Poland
facility: Lekarze Specjalisci J. Malolepszy i Partnerzy
city: Zabrze
country: Poland
facility: Medical Center Clinhouse
city: Guaynabo
country: Puerto Rico
facility: Allianze Pulmonary Research LLC
city: Cluj-Napoca
country: Romania
facility: Cardos Rosca Medical S.R.L.
city: Timisoara
country: Romania
facility: Fundatia CardioPrevent
city: Mangaung
country: South Africa
facility: Iatros International
state: Free State
city: City Of Johannesburg
country: South Africa
facility: Newtown Clinical Research Centre
state: Gauteng
city: Centurion
country: South Africa
facility: Johese Clinical Research
city: City Of Cape Town
country: South Africa
facility: Dr. Ismail Abdullah Private Practice
city: Kempton Park
country: South Africa
facility: CLINRESCO, ARWYP Medical Suites
city: Krugersdorp
country: South Africa
facility: Ubuntu Clinical Research Sites
city: Pretoria
country: South Africa
facility: AES - DRS - Synexus Watermeyer Clinical Research Centre
city: Pretoria
country: South Africa
facility: Medicross Pretoria West, Jongaie Research
city: Somerset West
country: South Africa
facility: AES - DRS - Synexus - Helderberg Clinical Research Centre
city: Welkom
country: South Africa
facility: Dr Yacoob AK Private Practice
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Ponferrada
country: Spain
facility: Hospital El Bierzo
state: Leon
city: Torrejon de Ardoz
country: Spain
facility: Hospital Universitario de Torrejon
state: Madrid
city: Benalmadena Costa
country: Spain
facility: Vithas Xanit International Hospital
state: Malaga
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
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: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital de La Ribera
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Linköping
country: Sweden
facility: Clinical Trial Consultants - Linkoping
city: Orebro
country: Sweden
facility: Universitetssjukhuset Orebro (USO)
city: Solna
country: Sweden
facility: Clinical Trial Consultants - Karolinska
city: Stockholm
country: Sweden
facility: Akardo AB
city: Uppsala
country: Sweden
facility: Clinical Trial Consultants - Uppsala
city: Zurich
country: Switzerland
facility: Zurcher Reha Zentren Wald
city: Chang Hua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaoshiung City
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: New Taipei
country: Taiwan
facility: Far East Memorial Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
city: Bangkok
country: Thailand
facility: Chulalongkorn University
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University
city: Muang
country: Thailand
facility: Central Chest Institute of Thailand
city: Istanbul
country: Turkey
facility: Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi
city: Kirikkale
country: Turkey
facility: Kirikkale Universitesi Tip Fakultesi Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Rize Merkez
country: Turkey
facility: Rize Recep Tayyip Erdogan University Training and Research Hospital
city: Saricam
country: Turkey
facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
state: Yorkshire
city: Bellshill
country: United Kingdom
facility: AES - DRS - Synexus Scotland Clinical Research Centre
city: Birmingham
country: United Kingdom
facility: AES - DRS - Synexus Midlands Clinical Research Centre
city: Cardiff
country: United Kingdom
facility: AES - DRS - Synexus Wales Clinical Research Centre
city: Chesterfield
country: United Kingdom
facility: Royal Primary Care - Ashgate Manor
city: Chorley
country: United Kingdom
facility: AES - DRS - NW Consortium Lancashire
city: Corby
country: United Kingdom
facility: Lakeside Surgery
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Hexham
country: United Kingdom
facility: AES - DRS - Synexus Hexham Clinical Research Centre
city: High Wycombe
country: United Kingdom
facility: Velocity Clinical Research - High Wycombe - PPDS
city: Lancaster
country: United Kingdom
facility: Royal Lancaster Infirmary
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: Liverpool
country: United Kingdom
facility: AES - DRS - NW Consortium Merseyside
city: London
country: United Kingdom
facility: Velocity Clinical Research North London - Percy Road - PPDS
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: Manchester
country: United Kingdom
facility: AES - DRS - NW Consortium Manchester
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: