A Study to Evaluate the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease

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.

NCT Number	NCT07349524
Lead Sponsor	Reistone Biopharma Company Limited
Conditions	Chronic Obstructive Pulmonary Disease
Enrollment	300 participants
Start Date	2026-03-10
Primary Completion	2028-03 (estimated)
Study Completion	2028-04 (estimated)
Updated on ClinicalTrials.gov	2026-06-05