Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 185
Healthy volunteers: no

Brief summary:
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms:
arm 1: PT003 MDI Dose 1 arm 2: PT003 MDI Dose 2 arm 3: PT003 MDI Dose 3 arm 4: PT003 MDI Dose 4 arm 5: PT001 MDI arm 6: PT005 MDI

Interventions: intervention 1: PT003 intervention 2: PT001 intervention 3: PT005
Intervention descriptions: intervention 1: PT003 MDI administered as two puffs BID for 7 days intervention 2: PT001 MDI administered as two puffs BID for 7 days intervention 3: PT005 MDI administered as two puffs BID for 7 days

Protocol document: