Phase 3 Study of HSK39004 Inhalation Powder for Treating COPD in Adults Aged 40 to 80 Years

What this Trial Is About

Researchers are evaluating the efficacy and safety of HSK39004 inhalation powder in adults with Chronic Obstructive Pulmonary Disease COPD. This Phase III study involves participants aged 40 to 80 years who have had COPD symptoms for at least one year and meet specific lung function criteria. The study is randomized, double-blind, placebo-controlled, and parallel-group in design to compare HSK39004 with a placebo. Participants receive either HSK39004 dry powder inhaler at a dose of 0.75 mg twice daily or a placebo inhaler for 12 weeks. The medication is taken orally as inhaled powder. The study focuses on measuring lung function changes, specifically the forced expiratory volume FEV1 over a 12-hour period after 4 weeks of treatment. During the study, participants will undergo lung function tests to monitor FEV1 and other safety assessments. Researchers will track symptoms and adverse effects throughout the 12-week treatment period. The primary outcome is the change in lung function after 4 weeks, with ongoing monitoring for the full 12 weeks. Participants safety and health will be closely followed until study completion.

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase III Study of HSK39004 Inhalation Powder for the Treatment of COPD