A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

Completed · Phase 3

Conditions studied: Chronic Obstructive Pulmonary Disorder

In brief

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

Key facts

Study ID

NCT02727660

Run by

Pearl Therapeutics, Inc.

People needed

1876

Starts

2016-04-29

Expected to finish

2018-04-04

Last updated by the study team

2019-09-26

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Give their signed written informed consent to participate
• At least 40 years of age and no older than 80 years of age
• COPD patients who are symptomatic
• Must be receiving one or more inhaled bronchodilators as maintenance therapy
• Must have a documented history of COPD exacerbations

You may not qualify if…

• Current diagnosis of asthma
• COPD due to α1-Antitrypsin Deficiency
• Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.
• Long-term-oxygen therapy (≥ 15 hours a day).

Where it is running

• Research Site — Huntsville, Alabama, United States
• Research Site — Sheffield, Alabama, United States
• Research Site — Flagstaff, Arizona, United States
• Research Site — Costa Mesa, California, United States
• Research Site — Gold River, California, United States
• Research Site — Lincoln, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Palo Alto, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Diego, California, United States
• Research Site — Upland, California, United States
• Research Site — Yorba Linda, California, United States
• Research Site — Boulder, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Chiefland, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Daytona Beach, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Kissimmee, Florida, United States
• Research Site — Leesburg, Florida, United States
• Research Site — Lehigh Acres, Florida, United States
• Research Site — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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