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

NCT06434792 | Recruiting Phase 2

• 1 other identifier: HL_HL301_204
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in CAT(COPD Assessment Test) total score at Visit 5

  Time frame: 3 months(Visit 5)

Secondary Outcomes (7)

• 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)

Study Arms (2)

Bronpass Tab.

EXPERIMENTAL

Twice daily for 12 weeks

Drug: Bronpass Tab.

Placebo

PLACEBO COMPARATOR

Twice daily for 12 weeks

Other: Placebo

Interventions

Bronpass Tab. DRUG

Twice daily for 12 weeks

Also known as: HL301

Bronpass Tab.

Placebo OTHER

Twice daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years ≤ age
• Patients who are diagnosed as COPD (based on the definition in the Korean Society of Tuberculosis and Respiratory Diseases COPD Guidelines)
• Patients who meet all of the following criteria at the screening test
• FEV1/FVC \< 0.70 after bronchodilator administration
• % ≤ FEV1 \< 80% predicted after bronchodilator administration
• Cough or sputum-related score on the CAT ≥ 3
• Current or former smokers with a smoking history of 10 pack-years or more at screening.
• Patients who have listened to a detailed explanation of this clinical trial, fully understand it, and voluntarily provide written consent to participate.

You may not qualify if:

• 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.)
• Patients with a medical history of respiratory diseases other than COPD
• Patients who have undergone lung volume reduction surgery.
• Patients with a history of lung transplantation.
• Patients with a history of respiratory infections within 4 weeks prior to screening
• Patients with a history of moderate or severe acute exacerbation within 4 weeks prior to screening.
• Pregnant or lactating women.
• Patients who are considered ineligible for this clinical trial due to other reasons as judged by the investigator.

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Konkuk University School of Medicine

Seoul, 05030, South Korea

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kwang Ha Yoo, MD, PhD

  Konkuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwang Ha Yoo, MD, PhD

CONTACT

82-2-2030-5114; 20130643@kuh.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: May 30, 2024
• Study Start: June 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

KR (1)