This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
26
Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks
Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements.
The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.
Time frame: Twelve (12) weeks
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