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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. 40 years ≤ age 2. Patients who are diagnosed as COPD (based on the definition in the Korean Society of Tuberculosis and Respiratory Diseases COPD Guidelines) 3. Patients who meet all of the following criteria at the screening test - FEV1/FVC \< 0.70 after bronchodilator administration - 30% ≤ FEV1 \< 80% predicted after bronchodilator administration - Cough or sputum-related score on the CAT ≥ 3 4. Current or former smokers with a smoking history of 10 pack-years or more at screening. 5. Patients who have listened to a detailed explanation of this clinical trial, fully understand it, and voluntarily provide written consent to participate. Who Should NOT Join This Trial: 1. Patients with a current medical history of asthma (However, patients previously diagnosed as asthma who have recovered and currently have a diagnosis of COPD are eligible for participation.) 2. Patients with a medical history of respiratory diseases other than COPD 3. Patients who have undergone lung volume reduction surgery. 4. Patients with a history of lung transplantation. 5. Patients with a history of respiratory infections within 4 weeks prior to screening 6. Patients with a history of moderate or severe acute exacerbation within 4 weeks prior to screening. 7. Pregnant or lactating women. 8. Patients who are considered ineligible for this clinical trial due to other reasons as judged by the investigator. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 40 years ≤ age 2. Patients who are diagnosed as COPD (based on the definition in the Korean Society of Tuberculosis and Respiratory Diseases COPD Guidelines) 3. Patients who meet all of the following criteria at the screening test * FEV1/FVC \< 0.70 after bronchodilator administration * 30% ≤ FEV1 \< 80% predicted after bronchodilator administration * Cough or sputum-related score on the CAT ≥ 3 4. Current or former smokers with a smoking history of 10 pack-years or more at screening. 5. Patients who have listened to a detailed explanation of this clinical trial, fully understand it, and voluntarily provide written consent to participate. Exclusion Criteria: 1. Patients with a current medical history of asthma (However, patients previously diagnosed as asthma who have recovered and currently have a diagnosis of COPD are eligible for participation.) 2. Patients with a medical history of respiratory diseases other than COPD 3. Patients who have undergone lung volume reduction surgery. 4. Patients with a history of lung transplantation. 5. Patients with a history of respiratory infections within 4 weeks prior to screening 6. Patients with a history of moderate or severe acute exacerbation within 4 weeks prior to screening. 7. Pregnant or lactating women. 8. Patients who are considered ineligible for this clinical trial due to other reasons as judged by the investigator.

Treatments Being Tested

DRUG

Bronpass Tab.

Twice daily for 12 weeks

OTHER

Placebo

Twice daily for 12 weeks

Locations (1)

Konkuk University School of Medicine
Seoul, South Korea