Actively Recruiting
Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmonary Disease
Led by Hanlim Pharm. Co., Ltd. · Updated on 2024-05-30
96
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 40 years or older
- Diagnosed with COPD according to Korean Society of Tuberculosis and Respiratory Diseases COPD Guidelines
- FEV1/FVC ratio less than 0.70 after bronchodilator use
- FEV1 between 30% and less than 80% predicted after bronchodilator use
- COPD Assessment Test (CAT) cough or sputum score of 3 or higher
- Current or former smokers with at least 10 pack-years smoking history
- Provided informed consent after understanding the clinical trial details
You will not qualify if you...
- Current medical history of asthma (except those previously diagnosed with asthma who have recovered and now diagnosed with COPD)
- History of respiratory diseases other than COPD
- Previous lung volume reduction surgery
- History of lung transplantation
- Respiratory infection within 4 weeks before screening
- Moderate or severe acute COPD exacerbation within 4 weeks before screening
- Pregnant or lactating women
- Considered ineligible by the investigator for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Konkuk University School of Medicine
Seoul, South Korea, 05030
Actively Recruiting
Research Team
K
Kwang Ha Yoo, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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