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

Phase 2

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Placebo; Drug: Bronpass Tab.

• Registration Number: NCT06434792
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

Brief 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.

Detailed Description

This study is to prove that Bronpass Tab. is superior in clinical efficacy and safety in improving COPD symptoms compared to placebo for 12 weeks in patients suffering from chronic obstructive pulmonary disease.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-09-18
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Primary Completion: 2024-09
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Twice daily for 12 weeks
Bronpass Tab.	Bronpass Tab.	Twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in CAT(COPD Assessment Test) total score at Visit 5	Time frame: 3 months(Visit 5)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in CAT cough score at Visit 3, Visit 4, and Visit 5	Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Change from baseline in CAT total score at Visit 3 and Visit 4	Time frame: 1 month(Visit 3), 2 months(Visit 4)
Change from baseline in SGRQ-C(St. George's Respiratory Questionnaire for COPD patients) Score at Visit 3, Visit 4, and Visit 5	Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Change from baseline in COAT(Cough Assessment Test) Score at Visit 3, Visit 4, and Visit 5	Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Change from baseline in CAT sputum score at Visit 3, Visit 4, and Visit 5	Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Incidence of moderate and severe COPD exacerbations from baseline to Visit 5	Time frame: 3 months(Visit 5)
Change frome baseline in PFT(Pulmonary Function Test) such as FEV1(Forced Expiratory Volume in one second), FVC(Forced Vital Capacity), FEV1/FVC at Visit 5	Time frame: 3 months(Visit 5)

Trial Locations

Locations (1)

Konkuk University School of Medicine; 🇰🇷 Seoul, Korea, Republic of