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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Bronpass Tab.; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kwang Ha Yoo, MD, PhD; Phone Number: 82-2-2030-5114; Email: 20130643@kuh.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05030
    • Recruiting
    • Konkuk University School of Medicine
    • Contact: Kwang Ha Yoo, MD, PhD; Phone Number: 82-2-2030-5114; Email: 20130643@kuh.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bronpass Tab.; Twice daily for 12 weeks	Drug: Bronpass Tab.; Twice daily for 12 weeks; Other Names: HL301
Placebo Comparator: Placebo; Twice daily for 12 weeks	Other: Placebo; Twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 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)
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)

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.
• Investigators: Principal Investigator: Kwang Ha Yoo, MD, PhD, Konkuk University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: HL_HL301_204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No