The study is being conducted to evaluate the efficacy and safety of HRS-9821 for patients with COPD, and to explore the reasonable dosage of HRS-9821 for patients with COPD.
Age ≥ 40 years old and < 80 years old, male or female.
Meet the weight standard.
Smoking history ≥ 10 pack-years.
COPD has been diagnosed ≥ 1 year.
History of life-threatening COPD.
Other pulmonary diseases that may affect the efficacy evaluation of this study.
Concurrent diseases other than COPD that may affect lung function.
History of asthma.
Parallel
HRS-9821 Inhalation Suspension
DrugHRS-9821 Inhalation Suspension.
HRS-9821 Placebo Inhalation Suspension
DrugHRS-9821 Placebo Inhalation Suspension.
Changes in peak FEV1 (forced expiratory volume in one second) after 28 days of treatment.
Changes in FEV1 area under the curve versus time from 0 to 12 hours (AUC0-12h) and 0 to 4 hours (AUC0-4h) after 1, 14 and 28 days of treatment.
Changes in peak FEV1 after 1 and 14 days of treatment.
Changes in trough FEV1 after 1, 14 and 28 days of treatment.
Changes in FVC (forced vital capacity) during 28 days of treatment.
Incidence and severity of adverse events (AEs) during the 7-week study period.
Safety outcome.
Plasma concentration of HRS-9821 after 1, 14 and 28 days of treatment.
Pharmacokinetic outcome.
Peak concentration after 1, 14 and 28 days of treatment.
Pharmacokinetic outcome.
Trough concentration after 1, 14 and 28 days of treatment.
Pharmacokinetic outcome.
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