Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 159
Healthy volunteers: no

Brief summary:
The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe 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: PT003 MDI Dose 5 arm 6: PT001 MDI arm 7: PT005 MDI arm 8: Tiotropium Bromide

Interventions: intervention 1: PT003 intervention 2: PT001 intervention 3: PT005 intervention 4: Tiotropium inhalation powder
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 intervention 4: Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days

Protocol document: