A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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 a placebo control in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

Key facts

Study ID

NCT02272634

Run by

Yungjin Pharm. Co., Ltd.

People needed

61

Starts

2015-06-04

Expected to finish

2017-11-08

Last updated by the study team

2023-07-14

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UAB Lung Health Center — Birmingham, Alabama, United States
• Florida Pulmonary Research Institute, LLC — Winter Park, Florida, United States
• Aventiv Research Inc. — Columbus, Ohio, United States
• Temple Lung Center, Temple University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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