Status:
COMPLETED
A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients
Lead Sponsor:
Yungjin Pharm. Co., Ltd.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
30-85 years
Phase:
PHASE2
Brief Summary
This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy, 3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice daily \[BID\]) and...
Detailed Description
Treatments are described as follows: Treatment A: Multiple oral YPL-001 80 mg doses (1 x 80 mg tablet + 1 x 1 YPL-001 80 mg matching placebo tablet) will be administered approximately every 12 hours ...
Eligibility Criteria
Inclusion
- Adult males and/or females, 30 to 85 years of age (inclusive).
- History of COPD for at least 12 months prior to screening.
- Diagnosed with COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD for at least 12 months prior to screening.
- Classified as moderate to severe COPD based on the current severity classification GOLD Stage 2-3 disease in terms of post-bronchodilator spirometry at screening
- etc.
Exclusion
- History of life-threatening COPD including respiratory arrest, intensive care unit admission and/or requiring intubation.
- History of more than 2 hospitalizations for COPD within 12 months prior to screening.
- Presentation of an acute exacerbation of COPD that will be associated with increase sputum volume or change in sputum color within 4 weeks before Day 1 of the Run-in Period.
- Evidence of pulmonary heart disease, or clinically significant pulmonary hypertension.
- etc.
Key Trial Info
Start Date :
June 4 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2017
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT02272634
Start Date
June 4 2015
End Date
November 8 2017
Last Update
July 14 2023
Active Locations (4)
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1
UAB Lung Health Center
Birmingham, Alabama, United States, 35249
2
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, United States, 32789
3
Aventiv Research Inc.
Columbus, Ohio, United States, 43213
4
Temple Lung Center, Temple University Hospital
Philadelphia, Pennsylvania, United States, 191140