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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— ARNASA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595642
• Other study ID #: GB44332
• Status: Recruiting
• Phase: Phase 3
• Start date: December 29, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: GB44332 https://forpatients.roche.com
• Phone: 888-662-6728
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1290
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Astegolimab
Participants will receive SC astegolimab Q2W or Q4W
• Placebo
Participants will receive SC placebo Q2W

Locations

Country	Name	City	State
Argentina	Centro Medico San Nicolas Grupo Orono	Buenos Aires
Argentina	Consultorios Medicos Organizacion de Buen Ayre SRL	Buenos Aires
Argentina	Fundacion Faicep	Buenos Aires
Argentina	Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias	Buenos Aires
Argentina	Nexo Salud Investigacion Clinica - Riobamba 429	Ciudad Autonoma Buenos Aires
Argentina	AES - AS - Glenny Corp. S.A. Buenos Aires	Ciudad Autonoma de Buenos Aires
Argentina	CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC	Ciudad Autonoma de Buenos Aires
Argentina	Centro de Medicina Respiratoria	Concepcion Del Uruguay
Argentina	Sanatorio de la Canada	Cordoba
Argentina	Centro Privado de Medicina Respiratoria	Entre Rios
Argentina	Centro Medico Capital	La Plata
Argentina	Centro Platense en Investigaciones Respiratorias	La Plata
Argentina	Framingham Centro Medico	La Plata
Argentina	Centro Medico Dharma	Mendoza
Argentina	Centro de Investigacion Pergamino SA	Pergamino
Argentina	Sala de primeros auxilios Alberto Mignaburu	Ranelagh, Berazategui
Argentina	Instituto Medico de la Fundacion Estudios Clinicos	Rosario
Argentina	Sanatorio Parque de Rosario	Rosario
Argentina	Servicio de Investigacion de Patologias Alergicas-Instituto ABC	Rosario
Argentina	Centro Modelo de Cardiologia	San Miguel de Tucuman
Argentina	CEPROSS- Centro Profesional San Salvador	San Salvador
Argentina	Centro de Diagnostico Y Rehabilitacion	Santa Fe
Argentina	Instituto Del Buen Aire	Santa Fe
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Institute for Respiratory Health Inc	Nedlands	Western Australia
Austria	Ordination Dr. Robert Voves	Feldbach
Austria	Ordination fur Lungenkrankheiten	Linz
Belgium	AZ Sint-Jan Brugge-Oostende	Brugge
Belgium	Universitair Ziekenhuis Brussel	Brussels
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	CHU de Liège	Liège
Brazil	Santa Casa de Misericordia de Belo Horizonte - PPDS	Belo Horizonte	MG
Brazil	Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu	Botucatu	SP
Brazil	L2IP ?Instituto de Pesquisas Clínicas Ltda.	Brasilia	DF
Brazil	Instituto Méderi de Pesquisa e Saúde	Passo Fundo	RS
Brazil	Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)	Porto Alegre	RS
Brazil	LMK Servicos Medicos SS	Porto Alegre	RS
Brazil	IBPCLIN Instituto Brasil de Pesquisa Clinica	Rio de Janeiro	RJ
Brazil	Faculdade de Medicina do ABC - FMABC	Santo Andre	SP
Brazil	CEMEC - Centro Multidisciplinar de Estudos Clínicos	Sao Bernardo Do Campo	SP
Brazil	Instituto do Coracao - HCFMUSP	Sao Paulo	SP
Brazil	CEDOES - Diagnóstico e Pesquisa	Vitoria	ES
Bulgaria	Multiprofile Hospital for Active Treatment Puls AD PPDS	Blagoevgrad
Bulgaria	Multiprofile Hospital For Active Treatment Sveta Ekaterina - Dimitrovgrad EOOD	Dimitrovgrad
Bulgaria	Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC	Gabrovo
Bulgaria	Multiprofile Hospital for Active Treatment Plovdiv	Plovdiv
Bulgaria	Multiprofile Hospital for Active Treatment Sv. Ivan Rilski- Razgrad AD	Razgrad
Bulgaria	Multiprofile Hospital for Active Treatment Shumen	Shumen
Bulgaria	Multiprofile Hospital for Active Treatment - Silistra AD	Silistra
Bulgaria	Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD	Smolyan
Bulgaria	AES DRS Medical Center Synexus Sofia EOOD	Sofia
Bulgaria	Diagnostic- Consultative Center Convex EOOD	Sofia
Bulgaria	Diagnostic-Consultative Center Aleksandrovska EOOD	Sofia
Bulgaria	Fifth Multiprofile Hospital for Active Treatment - Sofia EAD	Sofia
Bulgaria	MC Comac Medical	Sofia
Bulgaria	Medical Center Hera EOOD	Sofia
Bulgaria	Medical Center Researchexpert OOD	Varna
Bulgaria	Medical Center Tara OOD	Veliko Tarnovo
Canada	Dynamic Drug Advancement Ltd.	Ajax	Ontario
Canada	Edmonton Respiratory Consultants	Edmonton	Alberta
Canada	Recherche GCP Research	Montreal	Quebec
Canada	Centre Hospitalier de l'Universite Laval	Quebec
Canada	Clinique de pneumologie et du sommeil de Lanaudiere	Saint-Charles-Borromee	Quebec
Canada	Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location	Sherwood Park	Alberta
Canada	Inspiration Research	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Dr Anil Dhar Professional Medicine Corporation	Windsor	Ontario
Canada	Dr. Syed Anees Medicine Profession Corporation	Windsor	Ontario
Chile	Centro Respiratorio Integral LTDA. (CENRESIN)	Pavie Gallegos
Chile	Oncocentro APYS	Vina del Mar
Chile	Fundacion Medica San Cristobal	Vitacura
China	Beijing Jingmei Group General Hospital	Beijing
China	Peking University Shougang Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	Beijing Chaoyang Hospital Capital Medical University	Beijing City
China	Beijing Hospital	Beijing City
China	China-Japan Friendship Hospital	Beijing City
China	The First Hospital of Jilin University	Changchun City
China	The First Hospital of Changsha	Changsha
China	The Third Hospital of Changsha	Changsha
China	Chengdu Fifth People's Hospital	Chengdu
China	West China Hospital, Sichuan University	Chengdu
China	The Southwest Hospital of Army Medical University	Chongqing
China	Army Medical Center of PLA(Daping Hospital)	Chongqing City
China	Affiliated Hospital of Guangdong Medical University	Guangdong
China	Guangzhou First People's Hospital	Guangzhou
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Hainan General Hospital	Haikou
China	Hangzhou First People's Hospital	Hangzhou
China	Anhui Chest Hospital	Hefei
China	Huizhou Central People's Hospital	Huizhou
China	The First People's Hospital of Lian Yun Gang	Lianyungang
China	Taizhou Hospital of Zhejiang Province	Linhai
China	Jiangxi Provincial People's Hospital	Nanchang
China	Zhongda Hospital Southeast University	Nanjing
China	Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing City
China	Nantong First People's Hospital	Nantong
China	Jiangxi Pingxiang People's Hospital	Pingxiang
China	Huadong Hospital Affiliated to Fudan University	Shanghai
China	Shanghai Chest Hospital	Shanghai
China	Shengjing Hospital of China Medical University	ShenYang
China	Tianjin Medical University General Hospital	Tianjin
China	Central Hospital of Wuhan	Wuhan
China	Jiangyin People's Hospital	Wuxi
China	Wuxi People's Hospital	Wuxi
China	Zhongshan Hospital Xiamen University	Xiamen
China	Xi'an International Medical Center Hospital	Xian
China	Xinxiang First People's Hospital	Xinxiang
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou
China	Yangzhou First People?s Hospital	Yangzhou
China	The Fifth Affiliated Hospital Sun Yat-Sen University	Zhuhai City
China	Zigong First People's Hospital	Zigong
China	Affiliated Hospital of Zunyi Medical University	Zunyi
Czechia	Plicní ambulance MUDr. I. Cierná Peterová s.r.o.	Brandys nad Labem-Stara Boleslav
Czechia	Klinika nemoci plicnich a TBC FN Brno a LF MU - Ji	Brno
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Nemocnice Kyjov, prispevkova organizace	Kyjov
Czechia	Odborna plicni ambulance Opava s.r.o	Opava
Czechia	AES - DRS - Synexus Czech s.r.o.	Praha
Czechia	Ordinace chorob plicních s.r.o.	Praha 1
Czechia	Nemocnice Tabor, a.s.	Tabor
Czechia	Plicni stredisko Teplice s.r.o.	Teplice
Denmark	Naestved Sygehus	Næstved
Denmark	Sjaellands Universitetshospital, Roskilde	Roskilde
France	Sas Clinique De L Europe - Amiens	Amiens
France	Hopital Calmette	Lille
France	Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon	Paris
France	Hopital Haut Leveque	Pessac
France	CHU de Nancy-Hopital Brabois Adulte	Vandoeuvre
Germany	AES - DRS - Synexus Berlin Research Centre	Berlin
Germany	Evangelische Lungenklinik Berlin	Berlin
Germany	Praxis fur Kardiologie und Pneumologie Dr. med. Karin Forster	Berlin
Germany	Studienpraxis Berlin-Brandenburg, Berlin	Berlin
Germany	Lungenzentrum Darmstadt	Darmstadt
Germany	AES - DRS - Synexus Frankfurt Research Centre	Frankfurt
Germany	Universitaetsklinikum Frankfurt	Frankfurt
Germany	Clinical Research Hamburg	Hamburg
Germany	ME Clinical Respiratory Research Hamburg GmbH	Hamburg
Germany	Pneumologicum	Hannover
Germany	University Clinic Heidelberg	Heidelberg
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	AES - DRS - Synexus Leipzig Research Centre	Leipzig
Germany	BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz	Leipzig
Germany	KLB Gesundheitsforschung Lubeck GmbH	Lübeck
Germany	SMO.MD GmbH	Magdeburg
Germany	Praxis Dr. med. Jan Feimer	München
Germany	Institut fur klinische Forschung GmbH	Neu-Isenburg
Germany	framol-med GmbH	Rheine
Germany	Klinikum Rosenheim	Rosenheim
Greece	University General Hospital of Alexandroupolis	Alexandroupolis
Greece	Evangelismos General Hospital of Athens	Athens
Greece	Iatriko Palaiou Falirou	Athens
Greece	Navy Hospital of Athens	Athina
Greece	University General Hospital of Heraklion	Heraklio
Greece	University General Hospital of Ioannina	Ioannina
Greece	Georgios Papanikolaou General Hospital of Thessaloniki	Thessaloniki
Hong Kong	Queen Mary Hospital	Hong Kong
Hungary	Dr. Kenessey Albert Korhaz-Rendelointezet	Balassagyarmat
Hungary	Obudai Egeszsegugyi Centrum Kft.-Budapest	Budapest
Hungary	Omnimodus Elixír Kft.	Csorna
Hungary	AES - DRS - Synexus Debrecen Magyarorszag Egeszsegugyi Szolgaltato Kft	Debrecen
Hungary	Koch Robert Korhaz es Rendelointezet	Edeleny
Hungary	Veszprem Megyei Tudogyogyintezet	Farkasgyepu
Hungary	Erzsébet Gondozóház	Gödöll?
Hungary	Bugat Pal Korhaz	Gyongyos
Hungary	Szalay Janos Rendelointezet	Hajdunanas
Hungary	Komloi Egeszsegcentrum, Banyaszati Utokezelo Es Ejjeli Szanatorium Egeszsegugyi Kozpont	Komlo
Hungary	Szent Borbala Korhaz	Tatabánya
India	GMERS Medical College and Hospital, Sola	Ahmadabad City	Gujarat
India	Jaydeep Hospital	Ahmadabad CITY	Gujarat
India	CIMS Hospital	Ahmedabad	Gujarat
India	Jawaharlal Nehru Medical College (JNMC)	Ajmer	Rajasthan
India	ESIC Medical College and Hospital - Faridabad	Faridabad	Haryana
India	Karnataka Institute of Medical Sciences (KIMS), Hubbali	Hubli	Karnataka
India	Paarthiv Lung Care Center	Hyderabad	Telangana
India	Yashoda Hospitals Hitec City	Hyderabad	Andhra Pradesh
India	Maharaja Agrasen Super Speciality Hospital	Jaipur	Rajasthan
India	Sawai Man Singh Hospital and Medical College	Jaipur	Rajasthan
India	Apollo Spectra Hospital	Kanpur	Uttar Pradesh
India	Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital	Kolkata	WEST Bengal
India	MV Hospital and Research Centre	Lucknow	Uttar Pradesh
India	Criti Care Hospital & Research Institute - Nagpur	Nagpur	Maharashtra
India	Meditrina Institute of Medical Sciences	Nagpur	Maharashtra
India	Shree Hospital And Critical Care Centre	Nagpur	Maharashtra
India	Aakash Healthcare Super Speciality Hospital	New Delhi	Delhi
India	Sir Gangaram Hospital	NEW Delhi Delhi	Delhi
India	Kothrud Hospital	Pune City	Maharashtra
India	Government Medical College and Government General Hospital	Srikakulam	Andhra Pradesh
Israel	Soroka University Medical Centre	Beer Sheva
Israel	Lady Davis Carmel Medical Center	Haifa
Israel	Rambam Medical Center - PPDS	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar- Saba
Italy	Presidio Ospedaliero Santa Maria della Speranza	Battipaglia	Campania
Italy	Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele	Catania	Sicilia
Italy	Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna	Ferrara	Emilia-Romagna
Italy	Azienda Ospedaliera Universitaria Careggi	Florence	Toscana
Italy	ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco	Milano	Lombardia
Italy	Azienda Ospedaliera Dei Colli	Napoli	Campania
Italy	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Sicilia
Italy	Fondazione IRCCS Policlinico San Matteo di Pavia	Pavia	Lombardia
Italy	Fondazione Salvatore Maugeri IRCCS	Pavia	Lombardia
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia	Emilia-Romagna
Italy	Fondazione PTV Policlinico Tor Vergata	Rome	Lazio
Italy	Azienda Ospedaliero Universitaria Senese - Policlinico Santa Maria alle Scotte	Siena	Toscana
Japan	Nagoya Ekisaikai Hospital	Aichi
Japan	Asahikawa Medical Center	Asahikawa-shi
Japan	Fukuoka University - Chikushi Hospital	Chikushino-shi
Japan	Fukuwa Clinic	Chuo
Japan	Fukuoka University Hospital	Fukuoka
Japan	Nishi Fukuoka Hospital	Fukuoka-Shi Nishi-Ku
Japan	Terada Clinic Respiratory Medicine & General Practice	Himeji
Japan	Hiroshima Prefectural Hospital	Hiroshima
Japan	Ishikawa Prefectural Central Hospital	Ishikawa
Japan	National Hospital Organization Minami Kyoto Hospital	Joyo
Japan	Kagoshima University Hospital	Kagoshima
Japan	Yokohama City University Medical Center	Kanagawa
Japan	Osaka-Minami Medical Center	Kawachinagano-Shi
Japan	Kiryu Kosei General Hospital	Kiryu
Japan	Kishiwada City Hospital	Kishiwada
Japan	Hospital of the University of Occupational and Environmental Health,Japan	Kitakyushu-shi
Japan	Juntendo Tokyo Koto Geriatric Medical Center	Koto
Japan	Saiseikai Kumamoto Hospital	Kumamoto-Shi
Japan	National Hospital Organization Kyoto Medical Center	Kyoto
Japan	Rakuwakai Otowa Hospital	Kyoto
Japan	Machida Municipal Hospital	Machida-shi
Japan	Dokkyo Medical University Hospital	Mibu-Machi
Japan	Matsusaka City Hospital	Mie
Japan	Fukushima Medical University Hospital	Miyagi
Japan	Kojunkai Social Medical Corporation Daido Clinic	Nagoya-shi Minami-ku
Japan	Niigata City General Hospital	Niigata-shi
Japan	Oita Medical Center	Oita
Japan	National Hospital Organization Okayama Medical Center	Okayama
Japan	Okayama Rosai Hospital	Okayama-Shi Minami-ku
Japan	University of the Ryukyus Hospital	Okinawa
Japan	Omuta National Hospital	Omuta
Japan	National Hospital Organization - Sagamihara National Hospital	Sagamihara-shi Minami-ku
Japan	National Hospital Organization Kinki-Chuo Chest Medical Center	Sakai-shi
Japan	Sakaide City Hospital	Sakaide
Japan	Idaimae Minami 4-Jo Internal Medicine	Sapporo-shi Chuo-ku
Japan	Iwata City Hospital	Shizuoka
Japan	Shizuoka City Shimizu Hospital	Shizuoka
Japan	Kamei Internal Medicine and Respiratory Clinic	Takamatsu
Japan	National Hospital Organization Takasaki General Medical Center	Takasaki
Japan	Minami Wakayama Medical Center	Tanabe
Japan	Japanese Red Cross Medical Center	Tokyo
Japan	Nihon University Itabashi Hospital	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Japan	Toyama Prefectural Central Hospital	Toyama-Shi
Japan	Nagata Hospital	Yanagawa
Japan	Showa University Fujigaoka Hospital	Yokohama-shi Aoba-ku
Japan	Kanagawa Cardiovascular and Respiratory Center	Yokohama-shi Kanazawa-ku
Japan	National Hospital Organization - Yokohama Medical Center	Yokohama-Shi Totsuka-Ku
Japan	Sanyudo Hospital	Yonezawa
Kenya	KEMRI-MTWAPA Clinical Trial Site	Kilifi
Kenya	Clinical Research Health Network (CREA-N)	Machakos
Kenya	KEMRI CRDR Clinical Research Clinic Nairobi	Nairobi
Kenya	University of Nairobi Clinical Research Centre	Nairobi
Kenya	KEMRI/CRDR Siaya Clinical Research Annex	Siaya
Kenya	Center for Research In Tropical Medicine and community development	Thika
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon-si,
Korea, Republic of	Chungbuk National University Hospital	Cheongju si
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	CHA Bundang Medical Center	Gyeonggi-do
Korea, Republic of	Asan Medical Center - PPDS	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Samsung Medical Center - PPDS	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju-Si
Latvia	Daugavpils Regional Hospital, Outpatient Clinic	Daugavpils
Latvia	Health Center Association, Medical Center OLVI	Daugavpils
Latvia	Pauls Stradins Clinical University Hospital	R?ga
Latvia	Consilium Medicum	Riga
Latvia	Postgraduate Medical Training Institute University of Latvia	Riga
Latvia	Riga 1st Hospital	Riga
Mexico	Cryptex Investigacion Clinica SA de CV	Mexico	Mexico CITY (federal District)
Mexico	Oaxaca Site management Organization (OSMO) - PPDS	Oaxaca de Juárez	Mexico CITY (federal District)
Mexico	Centro Integral Médico SJR SC	Queretaro
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	PT&R	Beek
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Zuyderland Medisch Centrum - Heerlen	Heerlen
Netherlands	Gelre Ziekenhuizen, Zutphen	Zutphen
New Zealand	Auckland City Hospital	Auckland
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Waikato Hospital	Hamilton
New Zealand	P3 Research	Hastings
New Zealand	P3 Research - Kapiti - PPDS	Paraparaumu
Philippines	Manila Central University-Filemon D Tanchoco Medical Foundation	Caloocan City
Philippines	CARE CT Group Inc.	Dasmarinas
Philippines	Healthlink Medicalsurgicaldental Clinic and Diagnostic Center	Iloilo City
Philippines	West Visayas State University Medical Center	Iloilo City
Philippines	Mary Mediatrix Medical Center	Lipa City
Philippines	Manila Doctors Hospital	Manila
Philippines	Philippine Heart Center	Quezon City
Philippines	Quirino Memorial Medical Center	Quezon City
Poland	Centrum Medycyny Oddechowej Mroz sp. j.	Bia?ystok
Poland	Medical Center Kermed	Bydgoszcz
Poland	Vitamed Galaj i Cichomski sp.j.	Bydgoszcz
Poland	Centrum Medyczne Lukamed Joanna Luka-Wendrowska	Chojnice
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie	Cz?stochowa
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku	Gda?sk
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia
Poland	Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska	Grudzadz
Poland	Prywatny Gabinet Pulmonologiczny Joanna Nowacka-Apiyo	Grudziadz
Poland	Centrum Medyczne Katowice - PRATIA - PPDS	Katowice
Poland	Pro Familia Altera Sp z o.o.	Katowice
Poland	Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie	Krakow
Poland	Prywatna Praktyka Lekarska Adam Smialowski	Ksawerów
Poland	AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi	Lodz
Poland	AppleTreeClinics Network Sp. z o.o.	Lodz
Poland	Clinical Best Solutions - Lublin	Lublin
Poland	NZOZ Przychodnia Alergologiczno-pulmonologiczna	Lublin
Poland	ABC-Pulmo NZOZ Agnieszka Dobielska, Jaroslaw Dobie	Radom
Poland	NZOZ Poradnia Chorob Pluc i Alergologii	Slupsk
Poland	Centrum Medyczne KARDIOTEL	Sopot
Poland	Kiepury Clinic	Sosnowiec
Poland	NZOZ Poliklinika Doktora Bessera	Sosnowiec
Poland	Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych Dorota Malosek	Szczecin
Poland	CenterMed Bandrowskiego	Tarnow
Poland	MICS Centrum Medyczne Torun	Torun
Poland	Viltis Medica Specjalistyczna Praktyka Lekarska Lek. Med. Agata Kot	Trzebnica
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa
Poland	Lekarze Specjalisci J. Malolepszy i Partnerzy	Wroc?aw
Poland	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroc?aw
Poland	Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska	Wroclaw
Poland	Medical Center Clinhouse	Zabrze
Puerto Rico	CardioPulmonary Research Group	Guaynabo
Romania	Cardos Rosca Medical S.R.L.	Cluj-Napoca
Romania	Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova	Craiova
Romania	Fundatia CardioPrevent	Timisoara
South Africa	Iatros International	Bloemfontein
South Africa	Johese Clinical Research	Centurion
South Africa	Dr. Ismail Abdullah Private Practice	City Of Cape Town
South Africa	Newtown Clinical Research Centre	City Of Johannesburg
South Africa	CLINRESCO, ARWYP Medical Suites	Kempton Park
South Africa	Ubuntu Clinical Research Sites	Krugersdorp
South Africa	AES - DRS - Synexus Watermeyer Clinical Research Centre	Pretoria
South Africa	Medicross Pretoria West, Jongaie Research	Pretoria
South Africa	Roodepoort Medicross Research Centre	Roodepoort
South Africa	AES - DRS - Synexus - Helderberg Clinical Research Centre	Somerset West
South Africa	Dr Yacoob AK Private Practice	Welkom
Spain	Hospital de La Ribera	Alzira	Valencia
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Vithas Xanit International Hospital	Benalmadena Costa	Malaga
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario La Paz - PPDS	Madrid
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Islas Baleares
Spain	Hospital El Bierzo	Ponferrada	Leon
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario de Torrejon	Torrejon de Ardoz	Madrid
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Spain	Hospital Clinico Universitario de Valencia	Valencia
Sweden	Sahlgrenska Universitetssjukhuset	Goteborg
Sweden	Clinical Trial Consultants - Linkoping	Linkoping
Sweden	Universitetssjukhuset Orebro (USO)	Orebro
Sweden	Clinical Trial Consultants - Karolinska	Solna
Sweden	Akardo AB	Stockholm
Sweden	Clinical Trial Consultants - Uppsala	Uppsala
Switzerland	Zurcher Reha Zentren Wald	Zurich
Taiwan	Changhua Christian Hospital	Chang Hua
Taiwan	Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital	Kaoshiung City
Taiwan	Far East Memorial Hospital	New Taipei
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital - Linkou	Taoyuan
Thailand	Chulalongkorn University	Bangkok
Thailand	Srinagarind Hospital, Khon Kaen University	Khon Kaen
Thailand	Central Chest Institute of Thailand	Muang
Turkey	Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Kirikkale Universitesi Tip Fakultesi Hastanesi	Kirikkale
Turkey	Kocaeli University Hospital	Kocaeli
Turkey	Mersin University Medical Faculty	Mersin
Turkey	Rize Recep Tayyip Erdogan University Training and Research Hospital	Rize Merkez
Turkey	Cukurova Universitesi Tip Fakultesi Balcali Hastanesi	Saricam
United Kingdom	AES - DRS - Synexus Scotland Clinical Research Centre	Bellshill
United Kingdom	AES - DRS - Synexus Wales Clinical Research Centre	Cardiff
United Kingdom	Royal Primary Care - Ashgate Manor	Chesterfield
United Kingdom	AES - DRS - NW Consortium Lancashire	Chorley
United Kingdom	Lakeside Surgery	Corby
United Kingdom	Castle Hill Hospital	Cottingham
United Kingdom	University Hospital Coventry	Coventry
United Kingdom	AES - DRS - Synexus Midlands Clinical Research Centre	Edgbaston
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	AES - DRS - Synexus Hexham Clinical Research Centre	Hexham
United Kingdom	Velocity Clinical Research - High Wycombe - PPDS	High Wycombe
United Kingdom	Royal Lancaster Infirmary	Lancaster
United Kingdom	St James University Hospital	Leeds
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	AES - DRS - NW Consortium Merseyside	Liverpool
United Kingdom	St Thomas' Hospital	London
United Kingdom	Velocity Clinical Research North London - Percy Road - PPDS	London
United Kingdom	AES - DRS - NW Consortium Manchester	Manchester
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United States	Clinical Research Associates Of Central Pa , Llc	Altoona	Pennsylvania
United States	Pinnacle Research Group	Anniston	Alabama
United States	AES - DRS - Synexus Clinical Research US, Inc. - Atlanta	Atlanta	Georgia
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Kern Research	Bakersfield	California
United States	Paul A. Shapero, MD, PA	Bangor	Maine
United States	Nebraska Medical Research Institute, Inc. - CRN	Bellevue	Nebraska
United States	Hassman Research Institute - HRI - Berlin - CenExel - PPDS	Berlin	New Jersey
United States	AllerVie Clinical Research	Birmingham	Alabama
United States	Synexus Clinical Research US, Inc. - Birmingham	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	TTS Research	Boerne	Texas
United States	Meris Clinical Research	Brandon	Florida
United States	Urban Health Plan, Inc.	Bronx	New York
United States	University of Vermont Medical Center	Burlington	Vermont
United States	ClinSearch, LLC	Chattanooga	Tennessee
United States	Wellnow Urgent Care and Research ? Springdale	Cincinnati	Ohio
United States	Invictus Clinical Research Group, LLC	Coconut Creek	Florida
United States	Medtrial, LLC	Columbia	South Carolina
United States	Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPD	Columbus	Georgia
United States	Corsicana Medical Research	Corsicana	Texas
United States	Baylor University Medical Center	Dallas	Texas
United States	Research Carolina Elite	Denver	North Carolina
United States	Epic Medical Research LLC - DeSoto	DeSoto	Texas
United States	Duke Asthma Allergy and Airway Center	Durham	North Carolina
United States	OK Clinical Research	Edmond	Oklahoma
United States	Western Washington Medical Group	Everett	Washington
United States	Pulmonary Research Institute of Southeast Michigan	Farmington Hills	Michigan
United States	Care Access Research - Fayetteville - PPDS	Fayetteville	North Carolina
United States	Aa Mrc Llc	Flint	Michigan
United States	Clinical Trials Center of Middle Tennessee	Franklin	Tennessee
United States	Velocity Clinical Research - Gaffney - PPDS	Gaffney	South Carolina
United States	UF Health Pulmonary	Gainesville	Florida
United States	Clinical Research of Gastonia	Gastonia	North Carolina
United States	Pulmonary Associates	Glendale	Arizona
United States	Synexus Clinical Research US, Inc. - Phoenix West	Glendale	Arizona
United States	Finlay Medical Research Corporation	Greenacres City	Florida
United States	Allergy Asthma and Sinus Center-Greenfield	Greenfield	Wisconsin
United States	Pulmonix LLC	Greensboro	North Carolina
United States	ASHA Clinical Research - ClinEdge - PPDS	Hammond	Indiana
United States	Tennessee Comprehensive Lung & Sleep Center	Hendersonville	Tennessee
United States	Advances In Health Inc	Houston	Texas
United States	Baylor College of Medicine Medical Center	Houston	Texas
United States	Biopharma Informatic - Park Row - PPDS	Houston	Texas
United States	Clinical Trial Network	Houston	Texas
United States	Greater Heights Memorial Pulmonary and Sleep	Houston	Texas
United States	Methodist Hospital Research Institute	Houston	Texas
United States	Trio Clinical Trials	Houston	Texas
United States	Uni of Texas Health Science Center At Houston	Houston	Texas
United States	WellNow Urgent Care & Research - Huber Heights	Huber Heights	Ohio
United States	Advanced Respiratory and Sleep Medicine, PLLC	Huntersville	North Carolina
United States	R & H Clinical Research	Katy	Texas
United States	R & H Clinical Research	Katy	Texas
United States	Chemidox Clinical Trials Inc QCR HyperCore -PPDS	Lancaster	California
United States	The Machuca Foundation Inc	Las Vegas	Nevada
United States	Revive Research Institute	Lathrup Village	Michigan
United States	Revive Research Institute-32256 Northwestern Hwy	Lathrup Village	Michigan
United States	The Research Group of Lexington, LLC	Lexington	Kentucky
United States	Lynn Institute of The Ozarks - ERN - PPDS	Little Rock	Arkansas
United States	Cornerstone Research Institute	Longwood	Florida
United States	University of Louisville Research Foundation	Louisville	Kentucky
United States	Oakland Medical Research Center	Madison Heights	Michigan
United States	Care Access Research - Mauldin - PPDS	Mauldin	South Carolina
United States	Avantis Clinical Research, LLC	Miami	Florida
United States	Diverse Clinical Research, LLC	Miami	Florida
United States	Oceane7 Medical & Research Center, Inc.	Miami	Florida
United States	Research Institute of South Florida Inc	Miami	Florida
United States	San Marcus Research Clinic Inc.	Miami	Florida
United States	Virginia Research Center, LLC	Midlothian	Virginia
United States	Best Clinical Trials	New Orleans	Louisiana
United States	AES - DRS - Synexus Clinical Research US, Inc. - New York	New York	New York
United States	Providence Medical Center Noth Plainfield - 25 Cra	North Plainfield	New Jersey
United States	Central Florida Pulmonary Group, PA	Orlando	Florida
United States	Florida Institute for Clinical Research, LLC	Orlando	Florida
United States	Revival Clinical Research	Orlando	Florida
United States	Ormond Beach Clinical Research	Ormond Beach	Florida
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Allergy & Clinical Immun Assoc	Pittsburgh	Pennsylvania
United States	The Oregon Clinic	Portland	Oregon
United States	Renown Regional Medical Center Hospital	Reno	Nevada
United States	Saint Louis Veterans Affairs Medical Center - NAVREF - PPDS	Saint Louis	Missouri
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri
United States	University of Utah Hospitals & Clinics	Salt Lake City	Utah
United States	WellNow Urgent Care and Clinical Research - Niskayuna	Schenectady	New York
United States	Pivotal Research Solutions	Stonecrest	Georgia
United States	Tampa Bay Health Care	Tampa	Florida
United States	AES - DRS - Synexus Clinical Research US, Inc. - The Villages	The Villages	Florida
United States	AES - DRS - Synexus Clinical Research US, Inc. - Tucson	Tucson	Arizona
United States	Vital Prospects Clinical Research Institute PC - CRN	Tulsa	Oklahoma
United States	AES - DRS - Synexus Clinical Research US, Inc. - Vista	Vista	California
United States	Allergy & Asthma Medical Group of the Bay Area	Walnut Creek	California
United States	Cleveland Clinic Florida	Weston	Florida
United States	Southeastern Research Center	Winston-Salem	North Carolina
Vietnam	National Lung Hospital	Hanoi
Vietnam	Nhan Dan Gia Dinh Hospital	Ho Chi Minh City
Vietnam	University of Medicine Center, Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Czechia,  Denmark,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Japan,  Kenya,  Korea, Republic of,  Latvia,  Mexico,  Netherlands,  New Zealand,  Philippines,  Poland,  Puerto Rico,  Romania,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period		52 weeks
Secondary	Time to first moderate or severe COPD exacerbation during the 52-week treatment period		52 weeks
Secondary	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
Secondary	Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52		Week 52
Secondary	Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52		Week 52
Secondary	Proportion of participants with improvement in HRQoL at Week 52		Week 52
Secondary	Annualized rate of severe COPD exacerbations over the 52-week treatment period		52 weeks