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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Twice daily for 12 weeks
Twice daily for 12 weeks
Konkuk University School of Medicine
Seoul, South Korea
RECRUITINGChange from baseline in CAT(COPD Assessment Test) total score at Visit 5
Time frame: Time frame: 3 months(Visit 5)
Change from baseline in CAT total score at Visit 3 and Visit 4
Time frame: 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: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
Change from baseline in CAT sputum score at Visit 3, Visit 4, and Visit 5
Time frame: 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: 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: 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: 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: Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.