RecruitingPhase 2NCT07349524

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.


Sponsor

Reistone Biopharma Company Limited

Enrollment

300 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called RSS0343 tablets and a drug called RSS0343 tablets Placebo for people with chronic obstructive pulmonary disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 40 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRSS0343 tablets

RSS0343 tablets

DRUGRSS0343 tablets Placebo

RSS0343 tablets Placebo


Locations(1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT07349524


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