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

Hanlim Pharm. Co., Ltd.1 site in 1 country96 target enrollmentJune 1, 2023

ConditionsChronic Obstructive Pulmonary Disease

InterventionsBronpass Tab.Placebo

DrugsBronpass Tab.

Overview

Phase: Phase 2
Intervention: Bronpass Tab.
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Hanlim Pharm. Co., Ltd.
Enrollment: 96
Locations: 1
Primary Endpoint: Change from baseline in CAT(COPD Assessment Test) total score at Visit 5
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2023

End Date

March 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hanlim Pharm. Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•40 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
•30% ≤ 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.

Exclusion Criteria

•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.

Arms & Interventions

Bronpass Tab.

Twice daily for 12 weeks

Intervention: Bronpass Tab.

Placebo

Twice daily for 12 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Time frame: 3 months(Visit 5)

Secondary Outcomes

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 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))