Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 237
Healthy volunteers: no

Brief summary:
This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.

Detailed description:

Arms:
arm 1: PT005 MDI arm 2: PT001 MDI arm 3: PT003 MDI arm 4: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Interventions: intervention 1: PT005 MDI intervention 2: PT001 MDI intervention 3: PT003 MDI intervention 4: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Intervention descriptions: intervention 1: PT005 MDI administered as two puffs BID for 14 days intervention 2: PT001 MDI administered as two puffs BID for 14 days intervention 3: PT003 MDI administered as two puffs BID for 14 days intervention 4: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days

Protocol document: