A Phase 2a Study to Assess Safety, Daily Symptoms, Pharmacokinetics (PK), and Biomarkers of YPL-001 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Status: | Recruiting |
---|---|
Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 40 - 80 |
Updated: | 12/1/2016 |
Start Date: | March 2015 |
End Date: | July 2017 |
Contact: | Gerard J Criner, MD |
Phone: | 1-215-707-8113 |
A Randomized, Double-Blind, Placebo Controlled, Multicenter Phase 2a Study to Assess Safety, Daily Respiratory Symptoms, Pharmacokinetics, and Biomarker Variations After Administration of Either YPL-001, or Placebo in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
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.
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.
Inclusion Criteria:
- Adult males and/or females, 40 to 80 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 Criteria:
- 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.
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