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

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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.


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.
We found this trial at
4
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Birmingham, Alabama 35294
Phone: 205-934-5555
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Columbus, Ohio 43213
Phone: 614-501-6164
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Columbus, OH
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Philadelphia, Pennsylvania 19114
Phone: 215-707-8113
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Winter Park, Florida 32789
Phone: 407-740-8078
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Winter Park, FL
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