Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD

Completed · Phase 3

Conditions studied: Chronic Obstructive Pulmonary Disorder

In brief

This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.

Key facts

Study ID

NCT02766608

Run by

Pearl Therapeutics, Inc.

People needed

2389

Starts

2016-05-31

Expected to finish

2017-12-01

Last updated by the study team

2019-09-24

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
• Are at least 40 years of age and no older than 80 years
• COPD patients who are symptomatic
• Must be receiving one or more inhaled bronchodilators as maintenance therapy

You may not qualify if…

• Current diagnosis of asthma,
• COPD due to α1-Antitrypsin Deficiency
• Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
• Long-term-oxygen therapy (≥ 12 hours a day).

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Dothan, Alabama, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Anaheim, California, United States
• Research Site — Gold River, California, United States
• Research Site — Palm Springs, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — Boulder, Colorado, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Littleton, Colorado, United States
• Research Site — Hamden, Connecticut, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — DeLand, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Panama City, Florida, United States
• Research Site — Port Orange, Florida, United States
• Research Site — Port Orange, Florida, United States
• Research Site — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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