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

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. Subjects will undergo a 1- to
4-week Screening Period. Subjects who successfully complete the Screening Period will be to
one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg
BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following
randomization, subjects will enter the Treatment Period and undergo additional treatment
visits over 24 weeks.

Inclusion Criteria:

1. Give their signed written informed consent to participate

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

3. COPD patients who are symptomatic

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

Exclusion Criteria:

1. Current diagnosis of asthma,

2. COPD due to α1-Antitrypsin Deficiency

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

4. Long-term-oxygen therapy (≥ 12 hours a day).