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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronpass Tab. | Experimental | Twice daily for 12 weeks |
|
| Placebo | Placebo Comparator | Twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronpass Tab. | Drug | Twice daily for 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in CAT(COPD Assessment Test) total score at Visit 5 | Time frame: 3 months(Visit 5) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 cough score at Visit 3, Visit 4, and Visit 5 | Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5) |
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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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kwang Ha Yoo, MD, PhD | Contact | 82-2-2030-5114 | 20130643@kuh.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kwang Ha Yoo, MD, PhD | Konkuk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University School of Medicine | Recruiting | Seoul | 05030 | South Korea |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Placebo | Other | Twice daily for 12 weeks |
|
| 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) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |