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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
RSS0343 tablets
RSS0343 tablets Placebo
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGAnnualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period
Time frame: during the 48-week treatment period
The annualized rate of moderate or severe exacerbations of COPD at week 12, 24, and 36;
Time frame: at week 12, 24, and 36;
The time to first moderate or severe exacerbations of COPD at week 24 and 48;
Time frame: at week 24 and 48;
The proportion of patients experiencing moderate or severe exacerbations of COPD at week 24 and 48
Time frame: 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
Time frame: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in pre- and post-bronchodilator forced expiratory volume in FEV₁% predicted at week 4, 8, 12, 24, 36, 48, and 52
Time frame: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in pre- and post-bronchodilator forced expiratory volume in forced vital capacity (FVC) at week 4, 8, 12, 24, 36, 48, and 52;
Time frame: at week 4, 8, 12, 24, 36, 48, and 52;
The change from baseline in the COPD Assessment Test (CAT) score at week 4, 8, 12, 24, 36, 48, and 52
Time frame: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in the Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score at week 4, 8, 12, 24, 36, 48, and 52
Time frame: at week 4, 8, 12, 24, 36, 48, and 52
The change from baseline in the St. George's Respiratory Questionnaire (SGRQ) score at week 4, 8, 12, 24, 36, 48, and 52;
Time frame: at week 4, 8, 12, 24, 36, 48, and 52;
The proportion of patients with a SGRQ response (a ≥4-point decrease from baseline) at week 48;
Time frame: at week 48;
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