RecruitingPhase 2NCT06434792

Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmonary Disease

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Dose-response Phase 2 Clinical Trial to Compare the Efficacy and Safety of Bronpass Tab. Versus Placebo in Patients With Stable COPD


Sponsor

Hanlim Pharm. Co., Ltd.

Enrollment

96 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-response phase 2 clinical trial study to evaluate the efficacy and safety of Bronpass Tab. in 96 patients with chronic obstructive pulmonary disease.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the effectiveness and safety of a new tablet medication called Bronpass in people with chronic obstructive pulmonary disease (COPD) — a long-term lung condition that makes it hard to breathe. **You may be eligible if...** - You are 40 years of age or older - You have been diagnosed with COPD according to standard Korean guidelines - Your breathing tests show: FEV1/FVC below 0.70 and FEV1 between 30% and 80% of the predicted value after using a bronchodilator (a breathing medication) - Your cough or phlegm symptoms score at least 3 on the CAT questionnaire - You are a current or former smoker with at least a 10 pack-year history - You understand the trial and have given written consent to participate **You may NOT be eligible if...** - You currently have asthma (though prior asthma diagnosis may be acceptable if assessed by the investigator) - You have had a severe COPD flare-up requiring hospitalization recently - You have significant other lung, heart, or systemic conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

DRUGBronpass Tab.

Twice daily for 12 weeks

OTHERPlacebo

Twice daily for 12 weeks


Locations(1)

Konkuk University School of Medicine

Seoul, South Korea

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NCT06434792


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