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)

• Status: Completed
• Trial end date: 2018-04-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pearl Therapeutics, Inc.
• Treatments: Budesonide; Formoterol Fumarate

Criteria

Inclusion Criteria:

1. Give their signed written informed consent to participate

2. At least 40 years of age and no older than 80 years of age

3. COPD patients who are symptomatic

4. Must be receiving one or more inhaled bronchodilators as maintenance therapy

5. Must have a documented history of COPD exacerbations

Exclusion Criteria:

1. Current diagnosis of asthma

2. COPD due to α1-Antitrypsin Deficiency

3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.

4. Long-term-oxygen therapy (≥ 15 hours a day).