Phase II Study of RSS0343 Tablets to Treat Chronic Obstructive Pulmonary Disease COPD in Adults Aged 40 to 80

What this Trial Is About

Researchers are evaluating the efficacy and safety of RSS0343 tablets in patients with chronic obstructive pulmonary disease COPD. This Phase II, multicenter, randomized, double-blind, placebo-controlled clinical trial focuses on patients aged 40 to 80 years diagnosed with COPD, aiming to measure the annual rate of moderate or severe COPD exacerbations over a 48-week treatment period. The study consists of three periods a 4-week screening phase, a 48-week treatment phase where participants receive either RSS0343 tablets or a placebo, and a 4-week follow-up phase. Participants continue their usual COPD maintenance therapies and receive the study drug or placebo under close monitoring throughout the treatment period. Participants will undergo regular assessments including lung function tests such as forced expiratory volume FEV1 and forced vital capacity FVC, symptom evaluations with COPD Assessment Test CAT, Evaluating Respiratory Symptoms in COPD E-RSCOPD, and quality of life measures like the St. Georges Respiratory Questionnaire SGRQ. Researchers will track exacerbation rates, symptom changes, and safety throughout the study, with a total participation time of approximately 56 weeks.

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