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

NCT ID: NCT06434792

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bronpass Tab.

Twice daily for 12 weeks

Group Type EXPERIMENTAL

Bronpass Tab.

Intervention Type DRUG

Twice daily for 12 weeks

Placebo

Twice daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Twice daily for 12 weeks

Interventions

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Bronpass Tab.

Twice daily for 12 weeks

Intervention Type DRUG

Placebo

Twice daily for 12 weeks

Intervention Type OTHER

Other Intervention Names

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HL301

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kwang Ha Yoo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University

Locations

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Konkuk University School of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kwang Ha Yoo, MD, PhD

Role: CONTACT

82-2-2030-5114

Facility Contacts

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Kwang Ha Yoo, MD, PhD

Role: primary

82-2-2030-5114

Other Identifiers

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HL_HL301_204

Identifier Type: -

Identifier Source: org_study_id

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