Evaluation of the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Phase II, Randomized, Double-blind, Placebo-controlled Clinical Study.
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.
• Post-bronchodilator FEV₁/FVC \<0.7 at the screening period; and post-bronchodilator FEV₁/FVC \<0.7 with FEV₁% predicted ≥20% at baseline.
• Documented history of at least ≥1 moderate or severe acute exacerbation of COPD (AECOPD) within 12 months prior to screening.
• On stable doses of triple therapy or dual therapy for COPD maintenance treatment for ≥3 months prior to screening.
• COPD Assessment Test (CAT) score ≥10 at screening and randomization.
• Current or former smoking history of ≥10 pack-years at screening.
⁃ Male and female subjects of childbearing potential and their partners must have no plans for conception or sperm/ova donation for 6 months (female subjects) or 3 months (male subjects) after the last dose and must voluntarily use effective contraception. Female subjects of childbearing potential must have a negative pregnancy test during screening and prior to the first dose and must not be lactating.