Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 174
Healthy volunteers: no

Brief summary:
The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma.

This study will include a screening visit followed by a 4 month treatment period.

Detailed description:

Arms:
arm 1: Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose arm 2: Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose arm 3: Foradil Aerolizer, Low Dose arm 4: Foradil Aerolizer, High Dose arm 5: Dose matched placebo

Interventions: intervention 1: Formoterol Fumarate in the Pressair DPI, Low Dose intervention 2: Formoterol Fumarate in the Pressair DPI, High Dose intervention 3: Foradil Aerolizer, Low Dose intervention 4: Foradil Aerolizer, High Dose intervention 5: Placebo
Intervention descriptions: intervention 1: Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days intervention 2: Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days intervention 3: Foradil Aerolizer 12 micrograms, twice a day for 14 days intervention 4: Foradil Aerolizer 24 micrograms, twice per day for 14 days intervention 5: Placebo in the Pressair for 14 days

Protocol document: