Clinical trial NCT06434792: Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmonary Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in CAT(COPD Assessment Test) total score at Visit 5
timeFrame: Time frame: 3 months(Visit 5)
Secondary outcomes:
measure: Change from baseline in CAT total score at Visit 3 and Visit 4
timeFrame: Time frame: 1 month(Visit 3), 2 months(Visit 4)
measure: Change from baseline in CAT cough score at Visit 3, Visit 4, and Visit 5
timeFrame: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
measure: Change from baseline in CAT sputum score at Visit 3, Visit 4, and Visit 5
timeFrame: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
measure: Incidence of moderate and severe COPD exacerbations from baseline to Visit 5
timeFrame: Time frame: 3 months(Visit 5)
measure: 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
timeFrame: Time frame: 3 months(Visit 5)
measure: Change from baseline in SGRQ-C(St. George's Respiratory Questionnaire for COPD patients) Score at Visit 3, Visit 4, and Visit 5
timeFrame: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
measure: Change from baseline in COAT(Cough Assessment Test) Score at Visit 3, Visit 4, and Visit 5
timeFrame: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University School of Medicine
Study officials:
affiliation: Konkuk University
name: Kwang Ha Yoo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: