This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of RSS0343 tablets in patients with COPD. The study includes 3 study periods: a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period. The primary endpoint is the annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period.
Voluntarily sign a written informed consent form.
Aged 40 to 80 years, male or female.
Body mass index (BMI) ≥18 kg/m².
Diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the Chinese Guidelines for the Diagnosis and Management of COPD (2021 Revised Edition), with a documented COPD history of ≥12 months prior to screening.
Subjects with systemic immunosuppressants, biologic agents, or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug, whichever is longer.
Subjects with medications known to potentially cause skin hyperkeratosis within 4 weeks prior to screening.
Subjects with the followings within 4 weeks prior to randomization: systemic corticosteroids, phosphodiesterase inhibitors, xanthine derivatives, leukotriene receptor antagonists, bacterial lysates, antitussive/expectorant medications, infusion of blood products or immunoglobulins.
Subjects with strong CYP3A inducers or inhibitors within 14 days or 5 half-lives (whichever is longer) prior to randomization.
Parallel
RSS0343 tablets
DrugRSS0343 tablets
RSS0343 tablets Placebo
DrugRSS0343 tablets Placebo
Annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period
The annualized rate of moderate or severe exacerbations of COPD at week 12, 24, and 36；
The time to first moderate or severe exacerbations of COPD at week 24 and 48;
The proportion of patients experiencing moderate or severe exacerbations of COPD at week 24 and 48
The change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV₁) at week 4, 8, 12, 24, 36, 48, and 52
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