Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 892
Healthy volunteers: no

Brief summary:
This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)

Interventions: intervention 1: GFF MDI (PT 003) intervention 2: GP MDI (PT001) intervention 3: FF MDI (PT005) intervention 4: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)
Intervention descriptions: intervention 1: GFF MDI administered as two puffs BID intervention 2: GP MDI administered as two puffs BID intervention 3: FF MDI administered as two puffs BID intervention 4: Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)

Protocol document: