Evaluating Bronpass Tab. for 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

This study is testing if a new medication called Bronpass Tab. can help people with chronic obstructive pulmonary disease (COPD) feel better compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Hanlim Pharm. Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Seoul)
• Trial ID: NCT06434792 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, randomized, double-blind, placebo-controlled phase 2 trial designed to assess the efficacy and safety of Bronpass Tab. in patients diagnosed with chronic obstructive pulmonary disease (COPD). The study will involve 96 participants over a 12-week period, comparing the effects of Bronpass Tab. against a placebo. Patients will be monitored for improvements in COPD symptoms and overall health outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 40 and older who have been diagnosed with COPD and meet specific lung function criteria.

Not a fit: Patients with current asthma or other significant respiratory diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from COPD.

How similar studies have performed: Other studies have shown promise in evaluating treatments for COPD, but the specific approach of Bronpass Tab. is novel.

Eligibility criteria

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.

Where this trial is running

Seoul

• Konkuk University School of Medicine — Seoul, South Korea (Recruiting)

Study contacts

• Principal investigator: Kwang Ha Yoo, MD, PhD — Konkuk University
• Study coordinator: Kwang Ha Yoo, MD, PhD

Conditions Chronic Obstructive Pulmonary Disease