The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.
Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
Male or female adults ages 40 to 85 years old when signing the informed consent.
Current or former smokers with a smoking history of ≥10 pack-years.
Documented diagnosis of COPD for at least 12 months prior to enrolment
Presence of a known pre-existing, clinically important lung condition other than COPD.
A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
Diagnosis of α-1 anti-trypsin deficiency.
Presence of an active autoimmune disease.
Parallel
611
Drug611 subcutaneous (SC) injection
Placebo
Drugplacebo Q2W, subcutaneous (SC) injection
Annualized rate of moderate or severe COPD Exacerbations
Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) event that required systemic corticosteroids with/without antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death.
Change from baseline in pre-bronchodilator FEV1 at Week 24
FEV1 is the Forced expiratory volume in one second at study site
Time to first Moderate or severe COPD exacerbation
Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) event that required systemic corticosteroids with/without antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death.
Annualized rate of severe COPD Exacerbations
Severe exacerbations were recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death.
Change from baseline in pre-bronchodilator FEV1
FEV1 is the Forced expiratory volume in one second at study site
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