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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
174
Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
Foradil Aerolizer 12 micrograms, twice a day for 14 days
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
Time frame: Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment
Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of Period 1 The time-normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
Time frame: Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment
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Foradil Aerolizer 24 micrograms, twice per day for 14 days
Placebo in the Pressair for 14 days
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