Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmo… (NCT06434792) | Clinical Trial Compass
RecruitingPhase 2
Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmonary Disease
South Korea96 participantsStarted 2023-06-01
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
✕. 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.)
✕. Patients with a medical history of respiratory diseases other than COPD
✕. Patients who have undergone lung volume reduction surgery.
✕. Patients with a history of lung transplantation.
✕. Patients with a history of respiratory infections within 4 weeks prior to screening
✕. Patients with a history of moderate or severe acute exacerbation within 4 weeks prior to screening.
✕. Pregnant or lactating women.
What they're measuring
1
Change from baseline in CAT(COPD Assessment Test) total score at Visit 5