Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1615
Healthy volunteers: no

Brief summary:
This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.

Detailed description:

Arms:
arm 1: FF MDI administered as two puffs BID arm 2: GP MDI administered as two puffs BID arm 3: GFF MDI administered as two puffs BID arm 4: Inhaled placebo administered as two puffs BID

Interventions: intervention 1: GFF MDI (PT003) intervention 2: GP MDI (PT001) intervention 3: FF MDI (PT005) intervention 4: Placebo
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: None

Protocol document: