A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Korábbi kezelés

• Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
• History of long-term treatment with oxygen at >4.0 liters/minute
• Lung volume reduction surgery or procedure within 12 months prior to screening
• Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
• Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
• Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks 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

Más betegség

• History of clinically significant pulmonary disease other than COPD
• History of lung transplant

Egyéb

• Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible

• Documented physician diagnosis of COPD for at least 12 months
• History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
• Post-bronchodilator FEV1 >=20 and <80% of predicted normal value at screening
• Modified Medical Research Council (dyspnea scale) (mMRC) score >=2
• Current or former smoker with a minimum of 10 pack-year history
• History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA