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)

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.

Inclusion criteria

• 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

Exclusion criteria

• 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).