A Phase 2a Study to Assess Safety, Daily Symptoms, Pharmacokinetics (PK), and Biomarkers of YPL-001 in Chronic Obstructive Pulmonary Disease (COPD) Patients

• Status: Completed
• Trial end date: 2017-11-08
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yungjin Pharm. Co., Ltd.

Criteria

Inclusion Criteria:

• 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 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.