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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06434792
• Other study ID #: HL_HL301_204
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2023
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Hanlim Pharm. Co., Ltd.
• Contact: Kwang Ha Yoo, MD, PhD
• Phone: 82-2-2030-5114
• Email: 20130643[@]kuh.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Bronpass Tab.
Twice daily for 12 weeks

Other:
• Placebo
Twice daily for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in CAT(COPD Assessment Test) total score at Visit 5		Time frame: 3 months(Visit 5)
Secondary	Change from baseline in CAT total score at Visit 3 and Visit 4		Time frame: 1 month(Visit 3), 2 months(Visit 4)
Secondary	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)
Secondary	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)
Secondary	Incidence of moderate and severe COPD exacerbations from baseline to Visit 5		Time frame: 3 months(Visit 5)
Secondary	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)
Secondary	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)
Secondary	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)