Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmonary Disease
NCT ID: NCT06434792
Last Updated: 2024-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
96 participants
INTERVENTIONAL
2023-06-01
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bronpass Tab.
Twice daily for 12 weeks
Bronpass Tab.
Twice daily for 12 weeks
Placebo
Twice daily for 12 weeks
Placebo
Twice daily for 12 weeks
Interventions
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Bronpass Tab.
Twice daily for 12 weeks
Placebo
Twice daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
ALL
No
Sponsors
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Hanlim Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Kwang Ha Yoo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Konkuk University
Locations
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Konkuk University School of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HL_HL301_204
Identifier Type: -
Identifier Source: org_study_id
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