A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
ARNASA
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
2 other identifiers
interventional
1,290
37 countries
461
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2022
Longer than P75 for phase_3
461 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2022
CompletedFirst Posted
Study publicly available on registry
October 27, 2022
CompletedStudy Start
First participant enrolled
December 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2027
ExpectedApril 2, 2026
April 1, 2026
2.5 years
October 24, 2022
April 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period
52 weeks
Secondary Outcomes (6)
Time to first moderate or severe COPD exacerbation during the 52-week treatment period
52 weeks
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
Week 52
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52
Week 52
Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52
Week 52
Proportion of participants with improvement in HRQoL at Week 52
Week 52
- +1 more secondary outcomes
Study Arms (3)
Astegolimab SC Q2W
EXPERIMENTALParticipants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
Astegolimab SC Q4W
EXPERIMENTALParticipants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
Placebo SC Q2W
PLACEBO COMPARATORParticipants will receive SC placebo Q2W
Interventions
Participants will receive SC astegolimab Q2W or Q4W
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (462)
Pinnacle Research Group
Anniston, Alabama, 36207-4781, United States
AllerVie Clinical Research
Birmingham, Alabama, 35209-6802, United States
Synexus Clinical Research US, Inc. - Birmingham
Birmingham, Alabama, 35211-1320, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama, 36305, United States
Pulmonary Associates PA
Glendale, Arizona, 85306-4669, United States
Synexus Clinical Research US, Inc. - Phoenix West
Glendale, Arizona, 85306-4678, United States
AES - DRS - Synexus Clinical Research US, Inc. - Tucson
Tucson, Arizona, 85741-3118, United States
Lynn Institute of The Ozarks - ERN - PPDS
Little Rock, Arkansas, 72204-1505, United States
Kern Research
Bakersfield, California, 93301, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
AES - DRS - Synexus Clinical Research US, Inc. - Vista
Vista, California, 92083-6051, United States
Allergy & Asthma Medical Group of the Bay Area
Walnut Creek, California, 94598, United States
Cornerstone Research Institute
Altamonte Springs, Florida, 32701, United States
Invictus Clinical Research Group, LLC
Coconut Creek, Florida, 33073-3458, United States
Finlay Medical Research Corporation
Greenacres City, Florida, 33467-2979, United States
San Marcus Research Clinic Inc.
Miami, Florida, 33014, United States
Oceane7 Medical & Research Center, Inc.
Miami, Florida, 33144-2155, United States
Avantis Clinical Research, LLC
Miami, Florida, 33155-3265, United States
Research Institute of South Florida Inc
Miami, Florida, 33173, United States
Diverse Clinical Research, LLC
Miami, Florida, 33175-3434, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803, United States
Revival Clinical Research
Orlando, Florida, 32807, United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32822, United States
Ormond Beach Clinical Research
Ormond Beach, Florida, 32174-8196, United States
Tampa Bay Health Care
Tampa, Florida, 33615-4564, United States
AES - DRS - Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida, 32162-7116, United States
AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
Atlanta, Georgia, 30328, United States
Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPD
Columbus, Georgia, 31904-2954, United States
Pivotal Research Solutions
Stonecrest, Georgia, 30038-2649, United States
ASHA Clinical Research - ClinEdge - PPDS
Hammond, Indiana, 46324-2213, United States
The Research Group of Lexington, LLC
Lexington, Kentucky, 40504, United States
Best Clinical Trials
New Orleans, Louisiana, 70115, United States
Paul A. Shapero, MD, PA
Bangor, Maine, 04401-5691, United States
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, 48336-2817, United States
Flushing Road Internal Medicine and Pediatrics - F
Flint, Michigan, 48504-4730, United States
Revive Research Institute
Lathrup Village, Michigan, 48076, United States
Oakland Medical Research Center
Troy, Michigan, 48085-5524, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110, United States
Nebraska Medical Research Institute, Inc. - CRN
Bellevue, Nebraska, 68123-4318, United States
Machuca Family Medicine
Las Vegas, Nevada, 89104-3953, United States
Renown Regional Medical Center Hospital
Reno, Nevada, 89502-1576, United States
Hassman Research Institute - HRI - Berlin - CenExel - PPDS
Marlton, New Jersey, 08053, United States
AES - DRS - Synexus Clinical Research US, Inc. - New York
New York, New York, 10017-4008, United States
WellNow Urgent Care and Clinical Research - Niskayuna
Schenectady, New York, 12304-2268, United States
Research Carolina Elite
Denver, North Carolina, 28037-7929, United States
Care Access Research - Fayetteville - PPDS
Fayetteville, North Carolina, 28314-0260, United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054, United States
Pulmonix LLC
Greensboro, North Carolina, 27403, United States
Advanced Respiratory and Sleep Medicine, PLLC
Huntersville, North Carolina, 28078, United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103-4029, United States
Wellnow Urgent Care and Research ? Springdale
Cincinnati, Ohio, 45215-1170, United States
WellNow Urgent Care & Research - Huber Heights
Huber Heights, Ohio, 45424-4019, United States
OK Clinical Research
Edmond, Oklahoma, 73034-3258, United States
Vital Prospects Clinical Research Institute PC - CRN
Tulsa, Oklahoma, 74136, United States
The Oregon Clinic
Portland, Oregon, 97213, United States
Clinical Research Associates Of Central Pa , Llc
Altoona, Pennsylvania, 16602, United States
Allergy & Clinical Immun Assoc
Pittsburgh, Pennsylvania, 15241, United States
Medtrial, LLC
Columbia, South Carolina, 29204, United States
Velocity Clinical Research - Gaffney - PPDS
Gaffney, South Carolina, 29340-4737, United States
Care Access Research - Mauldin - PPDS
Mauldin, South Carolina, 29662, United States
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, 37067-5603, United States
Tennessee Comprehensive Lung & Sleep Center
Hendersonville, Tennessee, 37075-3085, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731-4915, United States
TTS Research
Boerne, Texas, 78006, United States
Corsicana Medical Research
Corsicana, Texas, 75110-2471, United States
Baylor University Medical Center
Dallas, Texas, 75231, United States
Epic Medical Research LLC - DeSoto
DeSoto, Texas, 75115, United States
Greater Heights Memorial Pulmonary and Sleep
Houston, Texas, 77008-1592, United States
Trio Clinical Trials
Houston, Texas, 77008, United States
Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
Uni of Texas Health Science Center At Houston
Houston, Texas, 77030, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Biopharma Informatic - Park Row - PPDS
Houston, Texas, 77084, United States
Advances In Health Inc
Houston, Texas, 77089-5716, United States
R & H Clinical Research
Katy, Texas, 77494-2031, United States
R & H Clinical Research
Katy, Texas, 77494-2031, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Western Washington Medical Group
Everett, Washington, 98208, United States
Allergy Asthma and Sinus Center-Greenfield
Greenfield, Wisconsin, 53228-3467, United States
Consultorios Medicos Organizacion de Buen Ayre SRL
Buenos Aires, 12345, Argentina
Nexo Salud Investigacion Clinica - Riobamba 429
Buenos Aires, C1025, Argentina
CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC
Buenos Aires, C1027AAP, Argentina
Fundacion Faicep
Buenos Aires, C1122AAK, Argentina
Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias
Buenos Aires, C1425, Argentina
AES - AS - Glenny Corp. S.A. Buenos Aires
Buenos Aires, C1430, Argentina
Centro de Medicina Respiratoria
Concepción del Uruguay, 3260, Argentina
Sanatorio de la Canada
Córdoba, X5000BSQ, Argentina
Framingham Centro Medico
La Plata, 1900, Argentina
Centro Medico Capital
La Plata, 1904, Argentina
Centro Platense en Investigaciones Respiratorias
La Plata, B1900BNN, Argentina
Centro Medico Dharma
Mendoza, M5500AYB, Argentina
Centro Privado de Medicina Respiratoria
Paraná, 3100, Argentina
Sala de primeros auxilios Alberto Mignaburu
Ranelagh, Berazategui, 1886, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, S2000DEJ, Argentina
Servicio de Investigacion de Patologias Alergicas-Instituto ABC
Rosario, S2013JKR, Argentina
Sanatorio Parque de Rosario
Rosario, S2013KZD, Argentina
Centro Modelo de Cardiologia
San Miguel de Tucumán, 4000, Argentina
Centro Medico San Nicolas Grupo Orono
San Nicolás de los Arroyos, B2900, Argentina
CEPROSS- Centro Profesional San Salvador
San Salvador, E3218CHH, Argentina
Instituto Del Buen Aire
Santa Fe, S3000ASF, Argentina
Centro de Diagnostico Y Rehabilitacion
Santa Fe, S3000, Argentina
Institute for Respiratory Health - Midland
Midland, South Australia, 6056, Australia
Ordination Dr. Robert Voves
Feldbach, 8330, Austria
Ordination fur Lungenkrankheiten
Linz, 4020, Austria
AZ Sint-Jan Brugge-Oostende
Bruges, 8000, Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
CHU de Liège
Liège, 4000, Belgium
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, 29055-450, Brazil
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, 70200-730, Brazil
Santa Casa de Misericordia de Belo Horizonte - PPDS
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, Rio Grande do Sul, 99010-120, Brazil
LMK Servicos Medicos SS
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu
Botucatu, São Paulo, 18618-687, Brazil
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, 09060-650, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, São Paulo, 09715-090, Brazil
IBPCLIN Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241-180, Brazil
Instituto do Coracao - HCFMUSP
São Paulo, 05403-000, Brazil
Multiprofile Hospital for Active Treatment Puls AD PPDS
Blagoevgrad, 2700, Bulgaria
Multiprofile Hospital For Active Treatment Sveta Ekaterina - Dimitrovgrad EOOD
Dimitrovgrad, 6400, Bulgaria
Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC
Gabrovo, 5300, Bulgaria
Medical Center Hera EOOD
Montana, 3400, Bulgaria
Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv, 4003, Bulgaria
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski- Razgrad AD
Razgrad, 7200, Bulgaria
Multiprofile Hospital for Active Treatment Shumen
Shumen, 9700, Bulgaria
Multiprofile Hospital for Active Treatment - Silistra AD
Silistra, 7500, Bulgaria
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
Smolyan, 4700, Bulgaria
Fifth Multiprofile Hospital for Active Treatment - Sofia EAD
Sofia, 1233, Bulgaria
Diagnostic-Consultative Center Aleksandrovska EOOD
Sofia, 1431, Bulgaria
Diagnostic- Consultative Center Convex EOOD
Sofia, 1680, Bulgaria
AES DRS Medical Center Synexus Sofia EOOD
Sofia, 1784, Bulgaria
Diagnostic Consultative Centre Mladost?M OOD
Varna, 9020, Bulgaria
Medical Center Tara OOD
Veliko Tarnovo, 5000, Bulgaria
Edmonton Respiratory Consultants
Edmonton, Alberta, T5J 3S9, Canada
Office of Irvin Mayers, MD
Edmonton, Alberta, T6G 2G3, Canada
Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location
Sherwood Park, Alberta, T8H 0N2, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Dynamic Drug Advancement Ltd.
Ajax, Ontario, L1S 2J5, Canada
Inspiration Research
Toronto, Ontario, M5T 3A9, Canada
Dr. Syed Anees Medicine Profession Corporation
Windsor, Ontario, N8X 1T3, Canada
Dr Anil Dhar Professional Medicine Corporation
Windsor, Ontario, N8X 5A6, Canada
Recherche GCP Research
Montreal, Quebec, H1Y 3H5, Canada
Clinique de pneumologie et du sommeil de Lanaudiere
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
Centre Hospitalier de l'Universite Laval
Québec, G1V 4G5, Canada
Centro Respiratorio Integral LTDA. (CENRESIN)
Pavie Gallegos, 2340000, Chile
Oncocentro APYS
Viña del Mar, 2520598, Chile
Fundacion Medica San Cristobal
Vitacura, 7630000, Chile
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510150, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510160, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
The First People's Hospital of Lian Yun Gang
Lianyungang, Jiangsu, 222061, China
Beijing Chaoyang Hospital Capital Medical University
Beijing, 100020, China
China-Japan Friendship Hospital
Beijing, 100029, China
Beijing Jingmei Group General Hospital
Beijing, 100042, China
Peking University Third Hospital
Beijing, 100191, China
Beijing Hospital
Beijing, 100730, China
Peking University Shougang Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, 130021, China
The First Hospital of Changsha
Changsha, 410005, China
The Third Hospital of Changsha
Changsha, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Chengdu Fifth People's Hospital
Chengdu, 611130, China
The Southwest Hospital of Army Medical University
Chongqing, 400038, China
Army Medical Center of PLA(Daping Hospital)
Chongqing, 400042, China
Guangzhou First People's Hospital
Guangzhou, 510180, China
Hainan General Hospital
Haikou, 570311, China
Hangzhou First People's Hospital
Hangzhou, 310006, China
Anhui Chest Hospital
Hefei, 230022, China
Huizhou Central People's Hospital
Huizhou, 516001, China
Taizhou Hospital of Zhejiang Province
Linhai, 317000, China
Jiangxi Provincial People's Hospital
Nanchang, 330006, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
Nantong First People's Hospital
Nantong, 226001, China
Jiangxi Pingxiang People's Hospital
Pingxiang, 337055, China
Huadong Hospital Affiliated to Fudan University
Shanghai, 200000, China
Shengjing Hospital of China Medical University
Shenyang, 110004, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Central Hospital of Wuhan
Wuhan, China
Wuxi People's Hospital
Wuxi, 214023, China
Jiangyin People's Hospital
Wuxi, 214400, China
Xi'an International Medical Center Hospital
Xi'an, 710100, China
Zhongshan Hospital Xiamen University
Xiamen, 361004, China
Xinxiang First People's Hospital
Xinxiang, 453000, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Yangzhou First People?s Hospital
Yangzhou, 225001, China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, 519001, China
Zigong First People's Hospital
Zigong, 643036, China
Plicní ambulance MUDr. I. Cierná Peterová s.r.o.
Brandýs nad Labem-Stará Boleslav, 250 01, Czechia
Klinika nemoci plicnich a TBC FN Brno a LF MU - Ji
Brno, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Nemocnice Kyjov, prispevkova organizace
Kyjov, 697 33, Czechia
Odborna plicni ambulance Opava s.r.o
Opava, 746 01, Czechia
Ordinace chorob plicních s.r.o.
Prague, 110 00, Czechia
AES - DRS - Synexus Czech s.r.o.
Prague, 120 00, Czechia
Nemocnice Tabor, a.s.
Tábor, 390 03, Czechia
Plicni stredisko Teplice s.r.o.
Teplice, 415 01, Czechia
Naestved Sygehus
Næstved, 4700, Denmark
Sjaellands Universitetshospital, Roskilde
Roskilde, 4000, Denmark
Sas Clinique De L Europe - Amiens
Amiens, 80090, France
Hopital Calmette
Lille, 59000, France
Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon
Paris, 75014, France
Hopital Haut Leveque
Pessac, 33604, France
CHU de Nancy-Hopital Brabois Adulte
Vandœuvre-lès-Nancy, 54511, France
Velocity Clinical Research Leipzig GmbH
Lübeck, Schleswig-Holstein, 23552, Germany
Praxis fur Kardiologie und Pneumologie Dr. med. Karin Forster
Berlin, 10367, Germany
Studienpraxis Berlin-Brandenburg, Berlin
Berlin, 12157, Germany
AES - DRS - Synexus Berlin Research Centre
Berlin, 12627, Germany
Lungenzentrum Darmstadt
Darmstadt, 64283, Germany
AES - DRS - Synexus Frankfurt Research Centre
Frankfurt, 60313, Germany
Universitaetsklinikum Frankfurt
Frankfurt, 60596, Germany
Clinical Research Hamburg
Hamburg, 22143, Germany
Praxisgem. Dres. Schmoller und Ehlers
Hamburg, 22299, Germany
Pneumologicum
Hanover, 30173, Germany
University Clinic Heidelberg
Heidelberg, 69120, Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
AES - DRS - Synexus Leipzig Research Centre
Leipzig, 04103, Germany
BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
Leipzig, 04299, Germany
SMO.MD GmbH
Magdeburg, 39120, Germany
Praxis Dr. med. Jan Feimer
München, 80539, Germany
Institut fur klinische Forschung GmbH
Neu-Isenburg, 63263, Germany
framol-med GmbH
Rheine, 48431, Germany
Klinikum Rosenheim
Rosenheim, 83022, Germany
University General Hospital of Alexandroupolis
Alexandroupoli, 681 00, Greece
Evangelismos General Hospital of Athens
Athens, 106 76, Greece
Navy Hospital of Athens
Athens, 115 21, Greece
University General Hospital of Heraklion
Heraklio, 711 10, Greece
University General Hospital of Ioannina
Ioannina, 455 00, Greece
Iatriko Palaiou Falirou
Palaió Fáliro, 175 62, Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, 570 10, Greece
Queen Mary Hospital
Hong Kong, Hong Kong
Benyovszky Medical Center
Budapest, 1089, Hungary
Omnimodus Elixír Kft.
Csorna, 9300, Hungary
Veszprem Megyei Tudogyogyintezet
Farkasgyepű, 8582, Hungary
Paarthiv Lung Care Center
Hyderabad, Andhra Pradesh, 500018, India
Yashoda Hospitals Hitec City
Hyderabad, Andhra Pradesh, 500084, India
Government Medical College and Government General Hospital
Srikakulam, Andhra Pradesh, 532001, India
GMERS Medical College and Hospital, Sola
Ahmedabad, Gujarat, 380059, India
ESIC Medical College and Hospital - Faridabad
Faridabad, Haryana, 121012, India
Karnataka Medical College and Research Institute, Hubballi;Department of Medicine
Hubballi, Karnataka, 580021, India
Shree Hospital And Critical Care Centre
Nagpur, Maharashtra, 044009, India
Kothrud Hospital
Pune, Maharashtra, 411038, India
Aakash Healthcare Super Speciality Hospital
New Delhi, National Capital Territory of Delhi, 110076, India
Sawai Man Singh Hospital and Medical College
Jaipur, Rajasthan, 302004, India
Maharaja Agrasen Super Speciality Hospital
Jaipur, Rajasthan, 302039, India
Jawaharlal Nehru Medical College (JNMC)
Aligarh, Uttar Pradesh, 202002, India
Apollo Spectra Hospital
Kanpur, Uttar Pradesh, 208001, India
MV Hospital and Research Centre
Lucknow, Uttar Pradesh, 226003, India
Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
Kolkata, West Bengal, 700020, India
Soroka University Medical Centre
Beersheba, 8410101, Israel
Rambam Medical Center - PPDS
Haifa, 3109601, Israel
Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Presidio Ospedaliero Santa Maria della Speranza
Battipaglia, Campania, 84091, Italy
Azienda Ospedaliera Dei Colli
Naples, Campania, 80131, Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
Ferrara, Emilia-Romagna, 44121, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, 42100, Italy
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, 00133, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milan, Lombardy, 20157, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Piedmont, 10043, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Sicily, 95123, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, 90127, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134, Italy
Azienda Ospedaliero Universitaria Senese - Policlinico Santa Maria alle Scotte
Siena, Tuscany, 53100, Italy
Makita Hospital
Sapporo, Hokkaido, 001-0901, Japan
Miura Medical Clinic
Miura-shi, Kanagawa, 238-0111, Japan
Yokohama Front Clinic
Yokohama, Kanagawa, 221-0835, Japan
Yokohama-Gumyouji Kokyuukinaika Naika Clinic
Yokohama, Kanagawa, 232-0066, Japan
Matsusaka City Hospital
Matsusaka-Shi, Mie-ken, 515-8544, Japan
University of the Ryukyus Hospital
Ginowan-shi, Okinawa, 901-2725, Japan
Fujieda Municipal General Hospital
Fujieda-Shi, Shizuoka, 426-8677, Japan
Yamaguchi University Hospital
Ube-shi, Yamaguchi, 755-8505, Japan
Asahikawa Medical Center
Asahikawa-shi, 070-0901, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502, Japan
National Hospital Organization Kyushu Medical Center
Chuo-ku, Fukuoka-shi, 810-8563, Japan
Fukuwa Clinic
Chūōku, 104-0031, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Nishi Fukuoka Hospital
Fukuoka-Shi Nishi-Ku, 819-0055, Japan
Terada Respiratory and Internal Clinic
Himeji, 670-0849, Japan
Hiroshima Prefectural Hospital
Hiroshima, 734-8530, Japan
Ishikawa Prefectural Central Hospital
Ishikawa, 920-8530, Japan
National Hospital Organization Minami Kyoto Hospital
Jōyō, 610-0113, Japan
Kagoshima Kouseiren Hospital
Kagoshima, 890-0062, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Yokohama City University Medical Center
Kanagawa, 232-0024, Japan
Osaka-Minami Medical Center
Kawachinagano-Shi, 586-8521, Japan
Kiryu Kosei General Hospital
Kiryū, 376-0024, Japan
Kishiwada City Hospital
Kishiwada, 596-0822, Japan
Hospital of the University of Occupational and Environmental Health,Japan
Kitakyushu-shi, 807-8556, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Kōtō City, 136-0075, Japan
Saiseikai Kumamoto Hospital
Kumamoto, 861-4101, Japan
Rakuwakai Otowa Hospital
Kyoto, 607-8062, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, 612-8555, Japan
Machida Municipal Hospital
Machida-shi, 194-0023, Japan
Dokkyo Medical University Hospital
Mibu-Machi, 321-0293, Japan
Fukushima Medical University Hospital
Miyagi, 960-1295, Japan
Nagoya Ekisaikai Hospital
Nagoya, 454-8502, Japan
Kojunkai Social Medical Corporation Daido Clinic
Nagoya-shi Minami-ku, 457-8511, Japan
National Hospital Organization Ibarakihigashi National Hospital
Naka-gun, 319-1113, Japan
Niigata City General Hospital
Niigata, 950-11977, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Okayama Rosai Hospital
Okayama-Shi Minami-ku, 702-8055, Japan
Omuta National Hospital
Omuta, 837-0911, Japan
Izumi City General Hospital
Osaka, 594-0073, Japan
Oita Medical Center
Ōita, 870-0263, Japan
National Hospital Organization - Sagamihara National Hospital
Sagamihara-shi Minami-ku, 252-0392, Japan
Sakaide City Hospital
Sakaidechō, 762-0043, Japan
NHO Kinki-Chuo Chest Medical Center
Sakaishi, 591-8555, Japan
Japan Community Health Care Organization Hokkaido Hospital
Sapporo, 062-8618, Japan
Idaimae Minami 4-Jo Internal Medicine
Sapporo-shi Chuo-ku, 064-0804, Japan
Shizuoka City Shizuoka Hospital
Shizuoka, 424-0911, Japan
Iwata City Hospital
Shizuoka, 438?8550, Japan
Kamei Internal Medicine and Respiratory Clinic
Takamatsu, 761-8073, Japan
National Hospital Organization Takasaki General Medical Center
Takasaki, 370-0829, Japan
Minami Wakayama Medical Center
Tanabe, 646-8558, Japan
Tokyo-Eki Center-building Clinic
Tokyo, 103-0027, Japan
Nihon University Itabashi Hospital
Tokyo, 173-8610, Japan
Japanese Red Cross Medical Center
Tokyo, Japan
Toyama Prefectural Central Hospital
Toyama, 930-8550, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Nagata Hospital
Yanagawa, 832-0059, Japan
Showa University Fujigaoka Hospital
Yokohama-shi Aoba-ku, 227-8501, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama-shi Kanazawa-ku, 236-0051, Japan
National Hospital Organization - Yokohama Medical Center
Yokohama-Shi Totsuka-Ku, 245-8575, Japan
Sanyudo Hospital
Yonezawa, 992-0033, Japan
KEMRI-MTWAPA Clinical Trial Site
Kilifi, Coast, 80108, Kenya
Clinical Research Health Network (CREA-N)
Machakos, 90100, Kenya
KEMRI CRDR Clinical Research Clinic Nairobi
Nairobi, 00100, Kenya
University of Nairobi Clinical Research Centre
Nairobi, Kenya
KEMRI/CRDR Siaya Clinical Research Annex
Siaya, 40600, Kenya
Center for Research In Tropical Medicine and community development
Thika, 01000, Kenya
Health Center Association, Medical Center OLVI
Daugavpils, LV-5410, Latvia
Daugavpils Regional Hospital
Daugavpils, LV-5417, Latvia
Pauls Stradins Clinical University Hospital
R?ga, LV-1002, Latvia
Riga 1st Hospital
Riga, LV-1001, Latvia
ConsiliumMedicum
Riga, LV-1010, Latvia
Postgraduate Medical Training Institute University of Latvia
Riga, LV-1011, Latvia
Meander Medisch Centrum
Amersfoort, 3813 TZ, Netherlands
Martini Ziekenhuis
Groningen, 9728 MG, Netherlands
Zuyderland Medisch Centrum - Heerlen
Heerlen, 6419PC, Netherlands
Greenlane Clinical Centre
Auckland, 1051, New Zealand
Dunedin Hospital
Dunedin, 9016, New Zealand
Waikato Hospital
Hamilton, 3248, New Zealand
P3 Research
Tauranga, 3110, New Zealand
P3 Research - Kapiti - PPDS
Waikanae Beach, 05036, New Zealand
Manila Central University-Filemon D Tanchoco Medical Foundation
Caloocan, 1442, Philippines
CARE CT Group Inc.
Dasmariñas, 4114, Philippines
Healthlink Medicalsurgicaldental Clinic and Diagnostic Center
Iloilo City, 5000, Philippines
West Visayas State University Medical Center
Iloilo City, 5000, Philippines
Mary Mediatrix Medical Center
Lipa City, 4217, Philippines
Philippine Heart Center
Quezon City, 1100, Philippines
Quirino Memorial Medical Center
Quezon City, 1109, Philippines
CenterMed Sp. z o.o.
Tarnów, Lesser Poland Voivodeship, 33-100, Poland
AppleTreeClinics Network Sp. z o.o.
Lodz, Lódzkie, 90-349, Poland
Centrum Medycyny Oddechowej Mroz sp. j.
Bia?ystok, 15-044, Poland
Vitamed Galaj i Cichomski sp.j.
Bydgoszcz, 85-079, Poland
Medical Center Kermed
Bydgoszcz, 85-231, Poland
Centrum Medyczne Lukamed Joanna Luka-Wendrowska
Chojnice, 89-600, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, 42-202, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gda?sk, 80-382, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-537, Poland
Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
Grudzadz, 86-300, Poland
Prywatny Gabinet Pulmonologiczny Joanna Nowacka-Apiyo
Grudziądz, 86-300, Poland
Centrum Medyczne Katowice - PRATIA - PPDS
Katowice, 40-081, Poland
Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, 31-826, Poland
Prywatna Praktyka Lekarska Adam Smialowski
Ksawerów, 95-054, Poland
AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
Lodz, 90-127, Poland
Clinical Best Solutions - Lublin
Lublin, 20-078, Poland
NZOZ Przychodnia Alergologiczno-pulmonologiczna
Lublin, 20-089, Poland
ABC-Pulmo NZOZ Agnieszka Dobielska, Jaroslaw Dobie
Radom, 26-600, Poland
Centrum Medyczne KARDIOTEL
Sopot, 81-741, Poland
Kiepury Clinic
Sosnowiec, 41-200, Poland
Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych Dorota Malosek
Szczecin, 70-111, Poland
NZOZ Poradnia Chorob Pluc i Alergologii
Słupsk, 76-200, Poland
MICS Centrum Medyczne Torun
Torun, 87-100, Poland
Viltis Medica Specjalistyczna Praktyka Lekarska Lek. Med. Agata Kot
Trzebnica, 55-100, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 01-192, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroc?aw, 50-381, Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroc?aw, 51-162, Poland
Lekarze Specjalisci J. Malolepszy i Partnerzy
Wroc?aw, 54-239, Poland
Medical Center Clinhouse
Zabrze, 41-807, Poland
Allianze Pulmonary Research LLC
Guaynabo, 00968, Puerto Rico
Cardos Rosca Medical S.R.L.
Cluj-Napoca, 400664, Romania
Fundatia CardioPrevent
Timișoara, 300134, Romania
Iatros International
Bloemfontein, Free State, 9301, South Africa
Newtown Clinical Research Centre
City of Johannesburg, Gauteng, Hillbrow 2001, South Africa
Johese Clinical Research
Centurion, 1692, South Africa
Dr. Ismail Abdullah Private Practice
City of Cape Town, 7764, South Africa
CLINRESCO, ARWYP Medical Suites
Kempton Park, 1619, South Africa
Ubuntu Clinical Research Sites
Krugersdorp, 1739, South Africa
AES - DRS - Synexus Watermeyer Clinical Research Centre
Pretoria, 0184, South Africa
Medicross Pretoria West, Jongaie Research
Pretoria, 183, South Africa
AES - DRS - Synexus - Helderberg Clinical Research Centre
Somerset West, 7130, South Africa
Dr Yacoob AK Private Practice
Welkom, 9459, South Africa
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 420-767, South Korea
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
CHA Bundang Medical Center
Gyeonggi-do, 13496, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Asan Medical Center - PPDS
Seoul, 05505, South Korea
Samsung Medical Center - PPDS
Seoul, 06351, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220-701, South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07010, Spain
Hospital El Bierzo
Ponferrada, LEON, 24411, Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid, 28850, Spain
Vithas Xanit International Hospital
Benalmádena Costa, Malaga, 29630, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario La Paz - PPDS
Barcelona, 8041, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital de La Ribera
Valencia, 46600, Spain
Clinical Trial Consultants - Linkoping
Uppsala, Uppsala County, 752 37, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Universitetssjukhuset Orebro (USO)
Örebro, 703 62, Sweden
Clinical Trial Consultants - Karolinska
Solna, 171 64, Sweden
Akardo AB
Stockholm, 117 27, Sweden
Clinical Trial Consultants - Uppsala
Uppsala, 752 37, Sweden
Zurcher Reha Zentren Wald
Zurich, Switzerland
Changhua Christian Hospital
Chang-hua, 500, Taiwan
Kaohsiung Medical University Hospital
Kaoshiung City, 807, Taiwan
Far East Memorial Hospital
New Taipei City, 220, Taiwan
Taipei Medical University Hospital
Taipei, 11031, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan District, 333, Taiwan
Chulalongkorn University
Bangkok, 10330, Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002, Thailand
Central Chest Institute of Thailand
Muang, 11000, Thailand
Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi
Istanbul, 34844, Turkey (Türkiye)
Kocaeli University Hospital
Kocaeli, 41380, Turkey (Türkiye)
Kirikkale Universitesi Tip Fakultesi Hastanesi
Kırıkkale, 71100, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33169, Turkey (Türkiye)
Rize Recep Tayyip Erdogan University Training and Research Hospital
Rize Merkez, 53020, Turkey (Türkiye)
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
Sarıçam, 01250, Turkey (Türkiye)
Castle Hill Hospital
Cottingham, Yorkshire, HU16 5JQ, United Kingdom
AES - DRS - Synexus Scotland Clinical Research Centre
Bellshill, ML4 3NJ, United Kingdom
AES - DRS - Synexus Midlands Clinical Research Centre
Birmingham, B15 2SQ, United Kingdom
AES - DRS - Synexus Wales Clinical Research Centre
Cardiff, CF15 9SS, United Kingdom
Royal Primary Care - Ashgate Manor
Chesterfield, S40 4AA, United Kingdom
AES - DRS - NW Consortium Lancashire
Chorley, PR7 7NA, United Kingdom
Lakeside Surgery
Corby, NN17 2UR, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
AES - DRS - Synexus Hexham Clinical Research Centre
Hexham, NE46 1QJ, United Kingdom
Velocity Clinical Research - High Wycombe - PPDS
High Wycombe, HP11 2QW, United Kingdom
Royal Lancaster Infirmary
Lancaster, LA1 4RP, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Glenfield Hospital
Leicester, LE3 9QP, United Kingdom
AES - DRS - NW Consortium Merseyside
Liverpool, L32 2AN, United Kingdom
Velocity Clinical Research North London - Percy Road - PPDS
London, N12 8BU, United Kingdom
St Thomas' Hospital
London, SE1 7EH, United Kingdom
AES - DRS - NW Consortium Manchester
Manchester, M15 6SE, United Kingdom
Norfolk and Norwich University Hospital
Norwich, NR4 7UY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
Reference Study ID Number: GB44332 https://forpatients.roche.com/
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2022
First Posted
October 27, 2022
Study Start
December 29, 2022
Primary Completion
June 24, 2025
Study Completion (Estimated)
September 24, 2027
Last Updated
April 2, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing