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)

Phase 3

Completed

Interventions: Drug: BFF MDI (PT009) 320/9.6 μg
Drug: BFF MDI (PT009) 160/9.6 μg
Drug: FF MDI (PT005) 9.6 μg

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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).

Arm && Interventions

Group	Intervention	Description
BFF MDI (PT009) 320/9.6 μg	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
BFF MDI (PT009) 160/9.6 μg	BFF MDI (PT009) 160/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
FF MDI (PT005) 9.6 μg	FF MDI (PT005) 9.6 μg	Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Primary Outcome Measures

Name	Time	Method
Morning Pre-dose Trough FEV1	at Week 12	Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12

Secondary Outcome Measures

Name	Time	Method
Time to First Moderate or Severe COPD Exacerbation	over 52 weeks	Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use	over 12 weeks	Change from baseline in average daily rescue Ventolin HFA use over 12 weeks
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score	at Week 12	The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.