Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 140
Healthy volunteers: no

Brief summary:
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

Detailed description:
The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None

Interventions: intervention 1: PT001 MDI intervention 2: Tiotropium Bromide intervention 3: PT001 Placebo MDI
Intervention descriptions: intervention 1: Administered as two puffs BID for 14 days intervention 2: Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI intervention 3: None

Protocol document: