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.
Кой може да участва
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
Места на провеждане
35
Argentina (1)
Consultorios Medicos Organizacion de Buen Ayre SRL
Buenos Aires
COMPLETED
Австралия (1)
Institute for Respiratory Health - Midland
Midland , South Australia
COMPLETED
Белгия (1)
AZ Sint-Jan Brugge-Oostende
Bruges
COMPLETED
Бразилия (1)
CEDOES - Diagnóstico e Pesquisa
Vitória , Espírito Santo
WITHDRAWN
България (1)
Multiprofile Hospital for Active Treatment Puls AD PPDS
Blagoevgrad
COMPLETED
Канада (1)
Edmonton Respiratory Consultants
Edmonton , Alberta
COMPLETED
Chile (1)
Centro Respiratorio Integral LTDA. (CENRESIN)
Pavie Gallegos
COMPLETED
Китай (1)
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou , Guangdong
COMPLETED
Чехия (1)
Plicní ambulance MUDr. I. Cierná Peterová s.r.o.
Brandýs nad Labem-Stará Boleslav
COMPLETED
Дания (1)
Naestved Sygehus
Næstved
COMPLETED
Франция (1)
Sas Clinique De L Europe - Amiens
Amiens
COMPLETED
Гърция (1)
University General Hospital of Alexandroupolis
Alexandroupoli
WITHDRAWN
Hong Kong (1)
Queen Mary Hospital
Hong Kong
WITHDRAWN
Унгария (1)
Benyovszky Medical Center
Budapest
COMPLETED
Индия (1)
Paarthiv Lung Care Center
Hyderabad , Andhra Pradesh
COMPLETED
Израел (1)
Soroka University Medical Centre
Beersheba
COMPLETED
Италия (1)
Presidio Ospedaliero Santa Maria della Speranza
Battipaglia , Campania
COMPLETED
Япония (1)
Makita Hospital
Sapporo , Hokkaido
Kenya (1)
KEMRI-MTWAPA Clinical Trial Site
Kilifi , Coast
COMPLETED
Latvia (1)
Health Center Association, Medical Center OLVI
Daugavpils
WITHDRAWN
Нидерландия (1)
Meander Medisch Centrum
Amersfoort
COMPLETED
New Zealand (1)
Greenlane Clinical Centre
Auckland
COMPLETED
Philippines (1)
Manila Central University-Filemon D Tanchoco Medical Foundation
Caloocan
COMPLETED
Полша (1)
CenterMed Sp. z o.o.
Tarnów , Lesser Poland Voivodeship
COMPLETED
Puerto Rico (1)
Allianze Pulmonary Research LLC
Guaynabo
COMPLETED
Румъния (1)
Cardos Rosca Medical S.R.L.
Cluj-Napoca
WITHDRAWN
South Africa (1)
Iatros International
Bloemfontein , Free State
COMPLETED
Южна Корея (1)
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
COMPLETED
Испания (1)
Hospital Universitario Son Espases
Palma de Mallorca , Balearic Islands
COMPLETED
Швеция (1)
Clinical Trial Consultants - Linkoping
Uppsala , Uppsala County
COMPLETED
Taiwan (1)
Changhua Christian Hospital
Chang-hua
COMPLETED
Тайланд (1)
Chulalongkorn University
Bangkok
WITHDRAWN
Турция (1)
Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi