NCT07349524

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

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 237 (estimated)
• Sponsor: Reistone Biopharma Company Limited · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	RSS0343 tablets	RSS0343 tablets
DRUG	RSS0343 tablets Placebo	RSS0343 tablets Placebo

Timeline

• Start date: 2026-03-10
• Primary completion: 2028-03-01
• Completion: 2028-04-01
• First posted: 2026-01-16
• Last updated: 2026-04-17

Locations

1 site across 1 country: China