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

Hanlim Pharm

Status and phase: Enrolling; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Placebo; Drug: Bronpass Tab.

Study type: Interventional

Funder types: Industry

Identifiers

NCT06434792

HL_HL301_204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups, including a placebo group

Bronpass Tab.

Experimental group

Description:

Twice daily for 12 weeks

Treatment:

Drug: Bronpass Tab.

Placebo

Placebo Comparator group

Description:

Twice daily for 12 weeks

Treatment:

Other: Placebo