A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (ARNASA)

March 26, 2024 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Buenos Aires, Argentina, C1122AAK
        • Recruiting
        • Fundacion Faicep
      • Buenos Aires, Argentina, 1425
        • Recruiting
        • Consultorios Medicos Organizacion de Buen Ayre SRL
      • Buenos Aires, Argentina, C1425
        • Recruiting
        • Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias
      • Buenos Aires, Argentina, B2900DPA
        • Recruiting
        • Centro Medico San Nicolas Grupo Orono
      • Ciudad Autonoma Buenos Aires, Argentina, C1025ABI
        • Recruiting
        • Nexo Salud Investigacion Clinica - Riobamba 429
      • Ciudad Autonoma de Buenos Aires, Argentina, C1027AAP
        • Recruiting
        • CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC
      • Ciudad Autonoma de Buenos Aires, Argentina, C1430
        • Recruiting
        • AES - AS - Glenny Corp. S.A. Buenos Aires
      • Concepcion Del Uruguay, Argentina, 3260
        • Recruiting
        • Centro de Medicina Respiratoria
      • Cordoba, Argentina, X5000BSQ
        • Recruiting
        • Sanatorio de la Canada
      • Entre Rios, Argentina, E3100BBJ
        • Recruiting
        • Centro Privado de Medicina Respiratoria
      • La Plata, Argentina, 1904
        • Recruiting
        • Centro Medico Capital
      • La Plata, Argentina, 1900
        • Recruiting
        • Framingham Centro Medico
      • La Plata, Argentina, B1900BNN
        • Recruiting
        • Centro Platense en Investigaciones Respiratorias
      • Mendoza, Argentina, 5500
        • Recruiting
        • Centro Medico Dharma
      • Ranelagh, Berazategui, Argentina, 1886
        • Recruiting
        • Sala de primeros auxilios Alberto Mignaburu
      • Rosario, Argentina, S2000DEJ
        • Recruiting
        • Instituto Medico de la Fundacion Estudios Clinicos
      • Rosario, Argentina, S2000DSV
        • Recruiting
        • Sanatorio Parque de Rosario
      • Rosario, Argentina, S2013JKR
        • Recruiting
        • Servicio de Investigacion de Patologias Alergicas-Instituto ABC
      • San Miguel de Tucuman, Argentina, 4000
        • Recruiting
        • Centro Modelo de Cardiología
      • San Salvador, Argentina, E3218CHH
        • Recruiting
        • CEPROSS- Centro Profesional San Salvador
      • Santa Fe, Argentina, 3000
        • Recruiting
        • Instituto Del Buen Aire
      • Santa Fe, Argentina, S3000
        • Recruiting
        • Centro de Diagnostico Y Rehabilitacion
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Institute for Respiratory Health Inc
      • Feldbach, Austria, 8330
        • Recruiting
        • Ordination Dr. Robert Voves
      • Linz, Austria, 4020
        • Recruiting
        • Ordination fur Lungenkrankheiten
      • Brugge, Belgium, 8000
        • Recruiting
        • AZ Sint-Jan Brugge-Oostende
      • Brussels, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel
      • Bruxelles, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liège
    • DF
      • Brasilia, DF, Brazil, 70200-730
        • Recruiting
        • L2IP ?Instituto de Pesquisas Clínicas Ltda.
    • MG
      • Belo Horizonte, MG, Brazil, 30150-221
        • Recruiting
        • Santa Casa de Misericordia de Belo Horizonte - PPDS
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20241-180
        • Recruiting
        • IBPClin Instituto Brasil de Pesquisa Clinica
    • RS
      • Passo Fundo, RS, Brazil, 99010-120
        • Recruiting
        • Instituto Méderi de Pesquisa e Saúde
      • Porto Alegre, RS, Brazil, 90610-000
        • Recruiting
        • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
      • Porto Alegre, RS, Brazil, 90480-000
        • Recruiting
        • LMK Servicos Medicos SS
    • SP
      • Botucatu, SP, Brazil, 18618-687
        • Recruiting
        • Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu
      • Sao Bernardo Do Campo, SP, Brazil, 09715-090
        • Recruiting
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
      • Sao Paulo, SP, Brazil, 05403-900
        • Recruiting
        • Instituto do Coração - HCFMUSP
      • Blagoevgrad, Bulgaria, 2700
        • Active, not recruiting
        • Multiprofile Hospital for Active Treatment Puls AD PPDS
      • Dimitrovgrad, Bulgaria, 6400
        • Active, not recruiting
        • Multiprofile Hospital For Active Treatment Sveta Ekaterina - Dimitrovgrad EOOD
      • Gabrovo, Bulgaria, 5300
        • Active, not recruiting
        • Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC
      • Plovdiv, Bulgaria, 4003
        • Active, not recruiting
        • Multiprofile Hospital for Active Treatment Plovdiv
      • Razgrad, Bulgaria, 7200
        • Active, not recruiting
        • Multiprofile Hospital for Active Treatment Sv. Ivan Rilski- Razgrad AD
      • Shumen, Bulgaria, 9700
        • Active, not recruiting
        • Multiprofile Hospital for Active Treatment Shumen
      • Silistra, Bulgaria, 7500
        • Active, not recruiting
        • Multiprofile Hospital for Active Treatment - Silistra AD
      • Smolyan, Bulgaria, 4700
        • Active, not recruiting
        • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
      • Sofia, Bulgaria, 1510
        • Active, not recruiting
        • Medical Center Hera Eood
      • Sofia, Bulgaria, 1612
        • Withdrawn
        • Mc Comac Medical
      • Sofia, Bulgaria, 1233
        • Active, not recruiting
        • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD
      • Sofia, Bulgaria, 1431
        • Active, not recruiting
        • Diagnostic-Consultative Center Aleksandrovska EOOD
      • Sofia, Bulgaria, 1680
        • Active, not recruiting
        • Diagnostic- Consultative Center Convex EOOD
      • Sofia, Bulgaria, 1784
        • Active, not recruiting
        • AES DRS Medical Center Synexus Sofia EOOD
      • Varna, Bulgaria, 9000
        • Active, not recruiting
        • Medical Center Researchexpert OOD
      • Veliko Tarnovo, Bulgaria, 5000
        • Active, not recruiting
        • Medical Center Tara OOD
      • Quebec, Canada, G1V 4G5
        • Recruiting
        • Centre Hospitalier de l'Universite Laval
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3S9
        • Recruiting
        • Edmonton Respiratory Consultants
      • Sherwood Park, Alberta, Canada, T8H 0N2
        • Recruiting
        • Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L8
        • Recruiting
        • Vancouver General Hospital
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Recruiting
        • Dynamic Drug Advancement Ltd.
      • Toronto, Ontario, Canada, M5T 3A9
        • Recruiting
        • Inspiration Research
      • Windsor, Ontario, Canada, N8X 1T3
        • Recruiting
        • Dr. Syed Anees Medicine Profession Corporation
      • Windsor, Ontario, Canada, N8X 5A6
        • Recruiting
        • Dr Anil Dhar Professional Medicine Corporation
    • Quebec
      • Montreal, Quebec, Canada, H1M 1B1
        • Recruiting
        • Recherche GCP Research
      • Pavie Gallegos, Chile, 2340000
        • Recruiting
        • Centro Respiratorio Integral LTDA. (CENRESIN)
      • Vina del Mar, Chile, 2520598
        • Recruiting
        • Oncocentro APYS
      • Vitacura, Chile, 7630000
        • Recruiting
        • Fundacion Medica San Cristobal
      • Beijing, China, 100042
        • Recruiting
        • Beijing Jingmei Group General Hospital
      • Beijing City, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
      • Beijing City, China, 100006
        • Recruiting
        • Beijing Hospital
      • Changchun City, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
      • Changsha, China
        • Recruiting
        • The Third Hospital of Changsha
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
      • Chengdu, China, 611130
        • Recruiting
        • Chengdu Fifth People's Hospital
      • Chongqing, China, 400038
        • Recruiting
        • The Southwest Hospital of Army Medical University
      • Guangdong, China, 524023
        • Recruiting
        • Affiliated Hospital of Guangdong Medical University
      • Guangzhou, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, China, 510180
        • Recruiting
        • Guangzhou First People's Hospital
      • Guangzhou, China, 510150
        • Recruiting
        • The Third Affiliated Hospital of Guangzhou Medical University
      • Hangzhou, China, 310006
        • Recruiting
        • Hangzhou First People's Hospital
      • Hefei, China
        • Recruiting
        • Anhui Chest Hospital
      • Huizhou, China, 516001
        • Recruiting
        • Huizhou Central People's Hospital
      • Lianyungang, China, 222023
        • Recruiting
        • The First People's Hospital of Lian Yun Gang
      • Linhai, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
      • Nanchang, China, 330006
        • Recruiting
        • Jiangxi Provincial People's Hospital
      • Nanjing, China, 210009
        • Recruiting
        • Zhongda Hospital Southeast University
      • Nantong, China, 226001
        • Recruiting
        • Nantong First People's Hospital
      • Pingxiang, China, 337055
        • Recruiting
        • Jiangxi Pingxiang People's Hospital
      • Shanghai, China, 200040
        • Recruiting
        • Huadong Hospital Affiliated To Fudan University
      • Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
      • Wuhan, China
        • Recruiting
        • Central Hospital of Wuhan
      • Wuxi, China, 214023
        • Recruiting
        • Wuxi People's Hospital
      • Wuxi, China, 214400
        • Recruiting
        • Jiangyin People's Hospital
      • Xiamen, China, 361004
        • Recruiting
        • Zhongshan Hospital Xiamen University
      • Xian, China, 710100
        • Recruiting
        • Xi'an International Medical Center Hospital
      • Xinxiang, China, 453000
        • Recruiting
        • Xinxiang First People's Hospital
      • Xuzhou, China
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
      • Yangzhou, China, 225001
        • Recruiting
        • Yangzhou First People?s Hospital
      • Zigong, China, 643036
        • Recruiting
        • Zigong First People's Hospital
      • Zunyi, China, 563000
        • Recruiting
        • Affiliated Hospital Of Zunyi Medical University
      • Brandys nad Labem-Stara Boleslav, Czechia, 250 01
        • Active, not recruiting
        • Plicní ambulance MUDr. I. Cierná Peterová s.r.o.
      • Hradec Kralove, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
      • Kyjov, Czechia, 697 33
        • Withdrawn
        • Nemocnice Kyjov, prispevkova organizace
      • Opava, Czechia, 746 01
        • Recruiting
        • Odborna plicni ambulance Opava s.r.o
      • Praha, Czechia, 120 00
        • Recruiting
        • AES - DRS - Synexus Czech s.r.o.
      • Praha 1, Czechia, 110 00
        • Recruiting
        • Ordinace chorob plicních s.r.o.
      • Tabor, Czechia, 390 03
        • Active, not recruiting
        • Nemocnice Tabor, a.s.
      • Teplice, Czechia, 415 01
        • Recruiting
        • Plicní středisko Teplice s.r.o.
      • Næstved, Denmark, 4700
        • Recruiting
        • Naestved Sygehus
      • Roskilde, Denmark, 4000
        • Recruiting
        • Sjaellands Universitetshospital, Roskilde
      • Amiens, France, 80090
        • Recruiting
        • Sas Clinique De L Europe - Amiens
      • Paris, France, 75014
        • Recruiting
        • Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon
      • Pessac, France, 33600
        • Recruiting
        • Hopital Haut Leveque
      • Vandoeuvre, France, 54511
        • Recruiting
        • CHU de Nancy-Hopital Brabois Adulte
      • Berlin, Germany, 10119
        • Recruiting
        • Studienpraxis Berlin-Brandenburg, Berlin
      • Berlin, Germany, 10367
        • Recruiting
        • Praxis fur Kardiologie und Pneumologie Dr. med. Karin Forster
      • Berlin, Germany, 13125
        • Withdrawn
        • Evangelische Lungenklinik Berlin
      • Berlin, Germany, 12627
        • Recruiting
        • AES - DRS - Synexus Berlin Research Centre
      • Darmstadt, Germany, 64283
        • Recruiting
        • Lungenzentrum Darmstadt
      • Frankfurt, Germany, 60313
        • Recruiting
        • AES - DRS - Synexus Frankfurt Research Centre
      • Frankfurt, Germany, 60596
        • Recruiting
        • Universitaetsklinikum Frankfurt
      • Hamburg, Germany, 22143
        • Recruiting
        • Clinical Research Hamburg
      • Hamburg, Germany, 22299
        • Recruiting
        • ME Clinical Respiratory Research Hamburg GmbH
      • Hannover, Germany, 30173
        • Recruiting
        • Pneumologicum
      • Heidelberg, Germany, 69120
        • Recruiting
        • University Clinic Heidelberg
      • Immenhausen, Germany, 34376
        • Recruiting
        • Lungenfachklinik Immenhausen
      • Leipzig, Germany, 04299
        • Recruiting
        • BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
      • Leipzig, Germany, 04103
        • Recruiting
        • AES - DRS - Synexus Leipzig Research Centre
      • Lübeck, Germany, 23552
        • Recruiting
        • KLB Gesundheitsforschung Lubeck GmbH
      • Magdeburg, Germany, 39120
        • Recruiting
        • SMO.MD GmbH
      • München, Germany, 80539
        • Recruiting
        • Praxis Dr. med. Jan Feimer
      • Neu-Isenburg, Germany, 63263
        • Recruiting
        • Institut fur klinische Forschung GmbH
      • Rheine, Germany, 48431
        • Recruiting
        • framol-med GmbH
      • Rosenheim, Germany, 83022
        • Recruiting
        • Klinikum Rosenheim
      • Alexandroupolis, Greece, 681 00
        • Recruiting
        • University General Hospital of Alexandroupolis
      • Athens, Greece, 106 76
        • Recruiting
        • Evangelismos General Hospital of Athens
      • Athens, Greece, 175 62
        • Recruiting
        • Iatriko Palaiou Falirou
      • Athina, Greece, 115 21
        • Recruiting
        • Navy Hospital of Athens
      • Heraklio, Greece, 711 10
        • Recruiting
        • University General Hospital of Heraklion
      • Ioannina, Greece, 455 00
        • Recruiting
        • University General Hospital of Ioannina
      • Thessaloniki, Greece, 570 10
        • Recruiting
        • Georgios Papanikolaou General Hospital of Thessaloniki
      • Hong Kong, Hong Kong, 999077
        • Recruiting
        • Queen Mary Hospital
      • Balassagyarmat, Hungary, 2660
        • Withdrawn
        • Dr. Kenessey Albert Kórház-Rendelőintézet
      • Csorna, Hungary, 9300
        • Recruiting
        • Omnimodus Elixír Kft.
      • Debrecen, Hungary, 4025
        • Withdrawn
        • AES - DRS - Synexus Debrecen Magyarorszag Egeszsegugyi Szolgaltato Kft
      • Farkasgyepu, Hungary, 8582
        • Recruiting
        • Veszprem Megyei Tudogyogyintezet
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500084
        • Recruiting
        • Yashoda Hospitals Hitec City
      • Srikakulam, Andhra Pradesh, India, 532001
        • Recruiting
        • Government Medical College and Government General Hospital
    • Delhi
      • New Delhi, Delhi, India, 110075
        • Recruiting
        • Aakash Healthcare Super Speciality Hospital
    • Gujarat
      • Ahmadabad City, Gujarat, India, 380059
        • Recruiting
        • GMERS Medical College and Hospital, Sola
    • Haryana
      • Faridabad, Haryana, India, 121012
        • Recruiting
        • ESIC Medical College and Hospital - Faridabad
    • Karnataka
      • Hubli, Karnataka, India, 580022
        • Recruiting
        • Karnataka Institute of Medical Sciences (KIMS), Hubbali
    • Maharashtra
      • Nagpur, Maharashtra, India, 044009
        • Recruiting
        • Shree Hospital And Critical Care Centre
      • Pune City, Maharashtra, India, 411038
        • Recruiting
        • Kothrud Hospital
    • Rajasthan
      • Ajmer, Rajasthan, India, 305001
        • Recruiting
        • Jawaharlal Nehru Medical College (JNMC)
      • Jaipur, Rajasthan, India, 302039
        • Recruiting
        • Maharaja Agrasen Super Speciality Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500018
        • Recruiting
        • Paarthiv Lung Care Center
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208001
        • Recruiting
        • Apollo Spectra Hospital
      • Lucknow, Uttar Pradesh, India, 226018
        • Recruiting
        • MV Hospital and Research Centre
    • WEST Bengal
      • Kolkata, WEST Bengal, India, 700020
        • Recruiting
        • Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
      • Beer Sheva, Israel, 8410101
        • Recruiting
        • Soroka University Medical Centre
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Medical Center - PPDS
      • Haifa, Israel, 34362
        • Recruiting
        • Lady Davis Carmel Medical Center
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
      • Kfar- Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center
    • Campania
      • Napoli, Campania, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera dei Colli
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italy, 44121
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
    • Lombardia
      • Milano, Lombardia, Italy, 20157
        • Recruiting
        • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
      • Pavia, Lombardia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo di Pavia
    • Sicilia
      • Catania, Sicilia, Italy, 95123
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
      • Palermo, Sicilia, Italy, 90127
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
    • Toscana
      • Florence, Toscana, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi
      • Siena, Toscana, Italy, 53100
        • Recruiting
        • Azienda Ospedaliero Universitaria Senese - Policlinico Santa Maria alle Scotte
      • Aichi, Japan, 454-8502
        • Recruiting
        • Nagoya Ekisaikai Hospital
      • Chuo, Japan, 103-0027
        • Recruiting
        • Fukuwa Clinic
      • Himeji, Japan, 670-0849
        • Recruiting
        • Terada Clinic Respiratory Medicine & General Practice
      • Hiroshima, Japan, 734-8530
        • Recruiting
        • Hiroshima Prefectural Hospital
      • Kyoto, Japan, 607-8062
        • Recruiting
        • Rakuwakai Otowa Hospital
      • Niigata-shi, Japan, 950-11977
        • Recruiting
        • Niigata City General Hospital
      • Shizuoka, Japan, 438?8550
        • Recruiting
        • Iwata City Hospital
      • Takamatsu, Japan, 761-8073
        • Recruiting
        • Kamei Internal Medicine and Respiratory Clinic
      • Tokyo, Japan, 103-0027
        • Recruiting
        • Tokyo-Eki Center-building Clinic
      • Yanagawa, Japan, 832-0059
        • Recruiting
        • Nagata Hospital
      • Kilifi, Kenya, 80108
        • Recruiting
        • KEMRI-MTWAPA Clinical Trial Site
      • Machakos, Kenya, 90100
        • Recruiting
        • Clinical Research Health Network (CREA-N)
      • Nairobi, Kenya, 00100
        • Recruiting
        • KEMRI CRDR Clinical Research Clinic Nairobi
      • Nairobi, Kenya
        • Recruiting
        • University of Nairobi Clinical Research Centre
      • Siaya, Kenya, 40600
        • Recruiting
        • KEMRI/CRDR Siaya Clinical Research Annex
      • Thika, Kenya, 01000
        • Active, not recruiting
        • Center for Research In Tropical Medicine and community development
      • Bucheon-si,, Korea, Republic of, 420-767
        • Recruiting
        • Soon Chun Hyang University Hospital Bucheon
      • Cheongju si, Korea, Republic of, 28644
        • Recruiting
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of, 42415
        • Recruiting
        • Yeungnam University Hospital
      • Gyeonggi-do, Korea, Republic of, 13496
        • Recruiting
        • CHA Bundang Medical Center
      • Seoul, Korea, Republic of, 06973
        • Recruiting
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of, 03181
        • Recruiting
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center - PPDS
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center - PPDS
      • Seoul, Korea, Republic of, 137-701
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Wonju-Si, Korea, Republic of, 220-701
        • Recruiting
        • Yonsei University Wonju Severance Christian Hospital
      • Daugavpils, Latvia, LV-5401
        • Recruiting
        • Daugavpils Regional Hospital, Outpatient Clinic
      • Daugavpils, Latvia, LV-5410
        • Recruiting
        • Health Center Association, Medical Center OLVI
      • R?ga, Latvia, LV-1002
        • Recruiting
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia, LV-1010
        • Recruiting
        • Consilium Medicum
      • Riga, Latvia, LV-1001
        • Recruiting
        • Riga 1st Hospital
      • Riga, Latvia, LV-1011
        • Active, not recruiting
        • Postgraduate Medical Training Institute University of Latvia
      • Amersfoort, Netherlands, 3813 TZ
        • Recruiting
        • Meander Medisch Centrum
      • Beek, Netherlands, 6191 JW
        • Withdrawn
        • PT&R
      • Groningen, Netherlands, 9728 NT
        • Recruiting
        • Martini Ziekenhuis
      • Heerlen, Netherlands, 6419PC
        • Recruiting
        • Zuyderland Medisch Centrum - Heerlen
      • Zutphen, Netherlands, 7207 AE
        • Withdrawn
        • Gelre Ziekenhuizen, Zutphen
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital
      • Dunedin, New Zealand
        • Recruiting
        • Dunedin Hospital
      • Hamilton, New Zealand, 3248
        • Recruiting
        • Waikato Hospital
      • Hastings, New Zealand, 4122
        • Recruiting
        • P3 Research
      • Paraparaumu, New Zealand, 5032
        • Recruiting
        • P3 Research - Kapiti - PPDS
      • Caloocan City, Philippines, 1442
        • Recruiting
        • Manila Central University-Filemon D Tanchoco Medical Foundation
      • Dasmarinas, Philippines, 4114
        • Recruiting
        • CARE CT Group Inc.
      • Iloilo City, Philippines, 5000
        • Recruiting
        • West Visayas State University Medical Center
      • Iloilo City, Philippines, 5000
        • Recruiting
        • Healthlink Medicalsurgicaldental Clinic and Diagnostic Center
      • Lipa City, Philippines, 4217
        • Recruiting
        • Mary Mediatrix Medical Center
      • Quezon City, Philippines, 1109
        • Recruiting
        • Quirino Memorial Medical Center
      • Quezon City, Philippines, 1104
        • Recruiting
        • Philippine Heart Center
      • Bia?ystok, Poland, 15-044
        • Recruiting
        • Centrum Medycyny Oddechowej Mroz sp. j.
      • Bydgoszcz, Poland, 85-079
        • Recruiting
        • Vitamed Galaj i Cichomski sp.j.
      • Bydgoszcz, Poland, 85-231
        • Recruiting
        • Medical Center Kermed
      • Chojnice, Poland, 89-600
        • Recruiting
        • Centrum Medyczne Lukamed Joanna Luka-Wendrowska
      • Cz?stochowa, Poland, 42-202
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
      • Gda?sk, Poland, 80-382
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdynia, Poland, 81-537
        • Recruiting
        • Synexus Polska Sp. z o.o. Oddzial w Gdyni
      • Grudzadz, Poland, 86-300
        • Recruiting
        • Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
      • Grudziadz, Poland, 86-300
        • Recruiting
        • Prywatny Gabinet Pulmonologiczny Joanna Nowacka-Apiyo
      • Katowice, Poland, 40-081
        • Recruiting
        • Centrum Medyczne Katowice - PRATIA - PPDS
      • Katowice, Poland, 40-645
        • Withdrawn
        • Pro Familia Altera Sp z o.o.
      • Krakow, Poland, 31-826
        • Recruiting
        • Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
      • Ksawerów, Poland, 95-054
        • Recruiting
        • Prywatna Praktyka Lekarska Adam Smialowski
      • Lodz, Poland, 90-349
        • Recruiting
        • AppleTreeClinics Network Sp. z o.o.
      • Lodz, Poland, 90-127
        • Recruiting
        • AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
      • Lublin, Poland, 20-078
        • Recruiting
        • Clinical Best Solutions - Lublin
      • Lublin, Poland, 20-089
        • Recruiting
        • NZOZ Przychodnia Alergologiczno-pulmonologiczna
      • Radom, Poland, 26-600
        • Recruiting
        • ABC-Pulmo NZOZ Agnieszka Dobielska, Jaroslaw Dobie
      • Slupsk, Poland, 76-200
        • Recruiting
        • NZOZ Poradnia Chorob Pluc i Alergologii
      • Sopot, Poland, 81-741
        • Recruiting
        • Centrum Medyczne KARDIOTEL
      • Sosnowiec, Poland, 41-200
        • Recruiting
        • Kiepury Clinic
      • Szczecin, Poland, 70-111
        • Recruiting
        • Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych Dorota Malosek
      • Tarnow, Poland, 33-100
        • Recruiting
        • CenterMed Bandrowskiego
      • Torun, Poland, 87-100
        • Recruiting
        • MICS Centrum Medyczne Torun
      • Trzebnica, Poland, 55-100
        • Recruiting
        • Viltis Medica Specjalistyczna Praktyka Lekarska Lek. Med. Agata Kot
      • Warszawa, Poland, 01-192
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
      • Wroc?aw, Poland, 54-239
        • Recruiting
        • Lekarze Specjalisci J. Malolepszy i Partnerzy
      • Wroc?aw, Poland, 50-381
        • Recruiting
        • Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
      • Wroclaw, Poland, 51-162
        • Recruiting
        • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
      • Zabrze, Poland, 41-807
        • Recruiting
        • Medical Center Clinhouse
      • Guaynabo, Puerto Rico, 00968
        • Recruiting
        • CardioPulmonary Research Group
      • Cluj-Napoca, Romania, 400664
        • Recruiting
        • Cardos Rosca Medical S.R.L.
      • Craiova, Romania, 200515
        • Recruiting
        • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova
      • Timisoara, Romania, 307200
        • Recruiting
        • Fundatia CardioPrevent
      • Bloemfontein, South Africa, 9301
        • Recruiting
        • Iatros International
      • Centurion, South Africa, 1692
        • Recruiting
        • Johese Clinical Research
      • City Of Johannesburg, South Africa, 2001
        • Recruiting
        • Newtown Clinical Research Centre
      • Kempton Park, South Africa, 1619
        • Recruiting
        • CLINRESCO, ARWYP Medical Suites
      • Krugersdorp, South Africa, 1739
        • Recruiting
        • Ubuntu Clinical Research Sites
      • Pretoria, South Africa, 0183
        • Recruiting
        • Medicross Pretoria West, Jongaie Research
      • Pretoria, South Africa, 0184
        • Recruiting
        • AES - DRS - Synexus Watermeyer Clinical Research Centre
      • Somerset West, South Africa, 7130
        • Recruiting
        • AES - DRS - Synexus - Helderberg Clinical Research Centre
      • Welkom, South Africa, 9459
        • Recruiting
        • Dr Yacoob AK Private Practice
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de la Princesa
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz - PPDS
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46014
        • Recruiting
        • Consorcio Hospital General Universitario de Valencia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Withdrawn
        • Hospital Universitario Germans Trias i Pujol
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07010
        • Recruiting
        • Hospital Universitario Son Espases
    • Leon
      • Ponferrada, Leon, Spain, 24411
        • Recruiting
        • Hospital El Bierzo
    • Madrid
      • Torrejon de Ardoz, Madrid, Spain, 28850
        • Recruiting
        • Hospital Universitario de Torrejon
    • Malaga
      • Benalmadena Costa, Malaga, Spain, 29630
        • Recruiting
        • Vithas Xanit International Hospital
    • Valencia
      • Alzira, Valencia, Spain, 46600
        • Recruiting
        • Hospital de la Ribera
      • Goteborg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
      • Linkoping, Sweden, 582 13
        • Recruiting
        • Clinical Trial Consultants - Linkoping
      • Orebro, Sweden, 703 62
        • Recruiting
        • Universitetssjukhuset Orebro (USO)
      • Solna, Sweden, 171 64
        • Recruiting
        • Clinical Trial Consultants - Karolinska
      • Stockholm, Sweden, 117 27
        • Recruiting
        • Akardo AB
      • Uppsala, Sweden, 752 37
        • Recruiting
        • Clinical Trial Consultants - Uppsala
      • Zurich, Switzerland
        • Recruiting
        • Zurcher Reha Zentren Wald
      • Chang Hua, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital
      • Kaoshiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
      • New Taipei, Taiwan, 220
        • Recruiting
        • Far East Memorial Hospital
      • Taipei, Taiwan, 11490
        • Recruiting
        • Tri-Service General Hospital
      • Taipei, Taiwan, 110
        • Recruiting
        • Taipei Medical University Hospital
      • Taipei City, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital - Linkou
      • Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Srinagarind Hospital, Khon Kaen University
      • Muang, Thailand, 11000
        • Recruiting
        • Central Chest Institute of Thailand
      • Istanbul, Turkey, 34844
        • Recruiting
        • Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi
      • Kirikkale, Turkey, 71100
        • Recruiting
        • Kirikkale Universitesi Tip Fakultesi Hastanesi
      • Kocaeli, Turkey, 41380
        • Recruiting
        • Kocaeli University Hospital
      • Mersin, Turkey, 33169
        • Recruiting
        • Mersin University Medical Faculty
      • Rize Merkez, Turkey, 53020
        • Recruiting
        • Rize Recep Tayyip Erdogan University Training and Research Hospital
      • Saricam, Turkey, 01250
        • Recruiting
        • Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
      • Bellshill, United Kingdom, ML4 3NJ
        • Recruiting
        • AES - DRS - Synexus Scotland Clinical Research Centre
      • Cardiff, United Kingdom, CF15 9SS
        • Recruiting
        • AES - DRS - Synexus Wales Clinical Research Centre
      • Chesterfield, United Kingdom, S40 4AA
        • Recruiting
        • Royal Primary Care - Ashgate Manor
      • Chorley, United Kingdom, PR7 7NA
        • Recruiting
        • AES - DRS - NW Consortium Lancashire
      • Corby, United Kingdom, NN17 2UR
        • Recruiting
        • Lakeside Surgery
      • Cottingham, United Kingdom, HU16 5JQ
        • Recruiting
        • Castle Hill Hospital
      • Coventry, United Kingdom, CV2 2DX
        • Recruiting
        • University Hospital Coventry
      • Edgbaston, United Kingdom, B15 2SQ
        • Recruiting
        • AES - DRS - Synexus Midlands Clinical Research Centre
      • Edinburgh, United Kingdom, EH16 4SA
        • Recruiting
        • Royal Infirmary of Edinburgh
      • Hexham, United Kingdom, NE46 1QJ
        • Recruiting
        • AES - DRS - Synexus Hexham Clinical Research Centre
      • High Wycombe, United Kingdom, HP11 2QW
        • Recruiting
        • Velocity Clinical Research - High Wycombe - PPDS
      • Lancaster, United Kingdom, LA1 4RP
        • Recruiting
        • Royal Lancaster Infirmary
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James University Hospital
      • Leicester, United Kingdom, LE3 9QP
        • Recruiting
        • Glenfield Hospital
      • Liverpool, United Kingdom, L32 2AN
        • Recruiting
        • AES - DRS - NW Consortium Merseyside
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • St Thomas' Hospital
      • London, United Kingdom, N12 8BU
        • Recruiting
        • Velocity Clinical Research North London - Percy Road - PPDS
      • Manchester, United Kingdom, M15 6SE
        • Recruiting
        • AES - DRS - NW Consortium Manchester
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospital
    • Alabama
      • Anniston, Alabama, United States, 36207-4781
        • Recruiting
        • Pinnacle Research Group
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35211-1320
        • Recruiting
        • Synexus Clinical Research US, Inc. - Birmingham
      • Birmingham, Alabama, United States, 35209-6802
        • Recruiting
        • Allervie Clinical Research
    • Arizona
      • Glendale, Arizona, United States, 85306-4669
        • Recruiting
        • Pulmonary Associates
      • Glendale, Arizona, United States, 85306-4678
        • Withdrawn
        • Synexus Clinical Research US, Inc. - Phoenix West
      • Tucson, Arizona, United States, 85741-3118
        • Recruiting
        • AES - DRS - Synexus Clinical Research US, Inc. - Tucson
    • Arkansas
      • Little Rock, Arkansas, United States, 72204-1505
        • Recruiting
        • Lynn Institute of The Ozarks - ERN - PPDS
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • Kern Research
      • Palo Alto, California, United States, 94304
        • Recruiting
        • VA Palo Alto Health Care System
      • Vista, California, United States, 92083-6051
        • Recruiting
        • AES - DRS - Synexus Clinical Research US, Inc. - Vista
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Allergy & Asthma Medical Group of the Bay Area
    • Florida
      • Brandon, Florida, United States, 33511-5719
        • Withdrawn
        • Meris Clinical Research
      • Coconut Creek, Florida, United States, 33073-3458
        • Recruiting
        • Invictus Clinical Research Group, LLC
      • Greenacres City, Florida, United States, 33467-2979
        • Recruiting
        • Finlay Medical Research Corporation
      • Longwood, Florida, United States, 32750-5307
        • Withdrawn
        • Cornerstone Research Institute
      • Miami, Florida, United States, 33014
        • Recruiting
        • San Marcus Research Clinic Inc.
      • Miami, Florida, United States, 33173
        • Recruiting
        • Research Institute of South Florida Inc
      • Miami, Florida, United States, 33155-3265
        • Recruiting
        • Avantis Clinical Research, LLC
      • Miami, Florida, United States, 33144-2155
        • Recruiting
        • Oceane7 Medical & Research Center, Inc.
      • Miami, Florida, United States, 33175-3434
        • Recruiting
        • Diverse Clinical Research, LLC
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Central Florida Pulmonary Group, PA
      • Ormond Beach, Florida, United States, 32174-8196
        • Recruiting
        • Ormond Beach Clinical Research
      • Tampa, Florida, United States, 33614-3221
        • Recruiting
        • Tampa Bay Health Care
      • The Villages, Florida, United States, 32162-7116
        • Recruiting
        • AES - DRS - Synexus Clinical Research US, Inc. - The Villages
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
      • Columbus, Georgia, United States, 31904-2954
        • Recruiting
        • Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPD
      • Stonecrest, Georgia, United States, 30038-2649
        • Recruiting
        • Pivotal Research Solutions
    • Indiana
      • Hammond, Indiana, United States, 46324-2213
        • Recruiting
        • ASHA Clinical Research - ClinEdge - PPDS
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Recruiting
        • The Research Group of Lexington, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • Best Clinical Trials
    • Maine
      • Bangor, Maine, United States, 04401-5691
        • Recruiting
        • Paul A. Shapero, MD, PA
    • Michigan
      • Farmington Hills, Michigan, United States, 48336-2817
        • Recruiting
        • Pulmonary Research Institute of Southeast Michigan
      • Flint, Michigan, United States, 48504-4730
        • Recruiting
        • Aa Mrc Llc
      • Lathrup Village, Michigan, United States, 48076
        • Recruiting
        • Revive Research Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine in St. Louis
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Nebraska Medical Research Institute, Inc. - CRN
    • Nevada
      • Las Vegas, Nevada, United States, 89101-3485
        • Recruiting
        • The Machuca Foundation Inc
      • Reno, Nevada, United States, 89502-1576
        • Recruiting
        • Renown Regional Medical Center Hospital
    • New Jersey
      • Berlin, New Jersey, United States, 08009-9263
        • Recruiting
        • Hassman Research Institute - HRI - Berlin - CenExel - PPDS
    • New York
      • New York, New York, United States, 10017-4008
        • Recruiting
        • AES - DRS - Synexus Clinical Research US, Inc. - New York
      • Schenectady, New York, United States, 12304-2268
        • Recruiting
        • WellNow Urgent Care and Clinical Research - Niskayuna
    • North Carolina
      • Denver, North Carolina, United States, 28037-7929
        • Recruiting
        • Research Carolina Elite
      • Fayetteville, North Carolina, United States, 28314-0260
        • Recruiting
        • Care Access Research - Fayetteville - PPDS
      • Greensboro, North Carolina, United States, 27403
        • Recruiting
        • Pulmonix LLC
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Advanced Respiratory and Sleep Medicine, PLLC
    • Ohio
      • Cincinnati, Ohio, United States, 45215-1170
        • Completed
        • Wellnow Urgent Care and Research ? Springdale
      • Huber Heights, Ohio, United States, 45424-4019
        • Withdrawn
        • WellNow Urgent Care & Research - Huber Heights
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Recruiting
        • OK Clinical Research
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Vital Prospects Clinical Research Institute PC - CRN
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • The Oregon Clinic
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Recruiting
        • Clinical Research Associates Of Central Pa , Llc
      • Pittsburgh, Pennsylvania, United States, 15241
        • Recruiting
        • Allergy & Clinical Immun Assoc
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Recruiting
        • Medtrial, LLC
      • Gaffney, South Carolina, United States, 29340-4737
        • Recruiting
        • Velocity Clinical Research - Gaffney - PPDS
      • Mauldin, South Carolina, United States, 29662
        • Recruiting
        • Care Access Research - Mauldin - PPDS
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Recruiting
        • ClinSearch, LLC
      • Franklin, Tennessee, United States, 37067-5663
        • Recruiting
        • Clinical Trials Center of Middle Tennessee
      • Hendersonville, Tennessee, United States, 37075-3085
        • Recruiting
        • Tennessee Comprehensive Lung & Sleep Center
    • Texas
      • Austin, Texas, United States, 78731-4915
        • Recruiting
        • FutureSearch Trials of Neurology
      • Corsicana, Texas, United States, 75110-2471
        • Recruiting
        • Corsicana Medical Research
      • Houston, Texas, United States, 77030
        • Recruiting
        • Uni of Texas Health Science Center At Houston
      • Houston, Texas, United States, 77074
        • Recruiting
        • Clinical Trial Network
      • Houston, Texas, United States, 77089-5716
        • Recruiting
        • Advances In Health Inc
      • Houston, Texas, United States, 77008-1772
        • Recruiting
        • Trio Clinical Trials
      • Houston, Texas, United States, 77089-6097
        • Recruiting
        • Biopharma Informatic - Park Row - PPDS
      • Houston, Texas, United States, 77008-1592
        • Recruiting
        • Greater Heights Memorial Pulmonary and Sleep
      • Katy, Texas, United States, 77494-2031
        • Recruiting
        • R & H Clinical Research
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
    • Virginia
      • Midlothian, Virginia, United States, 23114-3256
        • Withdrawn
        • Virginia Research Center, LLC
    • Washington
      • Everett, Washington, United States, 98208
        • Recruiting
        • Western Washington Medical Group
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228-3467
        • Recruiting
        • Allergy Asthma and Sinus Center-Greenfield

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Astegolimab SC Q2W
Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
Participants will receive SC astegolimab Q2W or Q4W
Experimental: Astegolimab SC Q4W
Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
Participants will receive SC astegolimab Q2W or Q4W
Placebo Comparator: Placebo SC Q2W
Participants will receive SC placebo Q2W
Participants will receive SC placebo Q2W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first moderate or severe COPD exacerbation during the 52-week treatment period
Time Frame: 52 weeks
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
Time Frame: Week 52
Week 52
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52
Time Frame: 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
Time Frame: Week 52
Week 52
Proportion of participants with improvement in HRQoL at Week 52
Time Frame: Week 52
Week 52
Annualized rate of severe COPD exacerbations over the 52-week treatment period
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2022

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease (COPD)

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