Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 103
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 demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

Arms:
arm 1: PT001 MDI arm 2: PT001 MDI arm 3: PT001 MDI arm 4: PT001 MDI arm 5: Ipratropium Bromide HFA Inhalation Aerosol arm 6: PT001 Placebo MDI

Interventions: intervention 1: PT001 MDI intervention 2: Ipratropium Bromide HFA Inhalation Aerosol intervention 3: Placebo MDI
Intervention descriptions: intervention 1: PT001 MDI administered as two puffs BID for 7 days intervention 2: Taken as 2 inhalations of the 17 µg per actuation strength MDI QID intervention 3: Matching placebo to PT001 MDI administered as two puffs BID for 7 days

Protocol document: