Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 118
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.

Detailed description:

Arms:
arm 1: PT003 MDI Dose 1 arm 2: PT003 MDI Dose 2 arm 3: PT005 MDI Dose 1 arm 4: PT005 MDI Dose 2 arm 5: Placebo MDI arm 6: Tiotropium Bromide inhalation powder arm 7: Formoterol fumarate inhalation powder 12 μg arm 8: PT001 MDI Dose 1

Interventions: intervention 1: PT003 MDI intervention 2: PT005 MDI intervention 3: Placebo MDI intervention 4: Tiotropium bromide 18 μg (Spiriva Handihaler®) intervention 5: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) intervention 6: PT001 MDI
Intervention descriptions: intervention 1: Inhaled PT003 MDI administered as two puffs BID for 7 days intervention 2: Inhaled PT005 MDI administered as two puffs BID for 7 days intervention 3: Inhaled placebo administered as two puffs BID for 7 days intervention 4: Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days intervention 5: Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days intervention 6: Inhaled PT001 MDI administered as two puffs BID for 7 days

Protocol document: