The purposes of this study are: * To demonstrate the efficacy of once daily administration of Nasacort AQ 110 µg compared with placebo in children 2-5 years of age with perennial allergic rhinitis; and * To assess the safety of Nasacort AQ 110 µg in children 2-5 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
460
Sanofi-Aventis, Inc.
Bridgewater, New Jersey, United States
Double-blind phase: Change from baseline in mean daily instantaneous (immediately prior to dosing) Total Nasal Symptom Score (TNSS) over the 4-week double-blind period
Open-label phase: The efficacy variable is the global evaluation of efficacy as rated by the physician and the subject
Change from baseline: in mean daily reflective (previous 24 hours) TNSS over 4-wk double-blind period
for mean daily instantaneous and reflective TNSS by week
for mean instantaneous and reflective daily scores for nasal stuffiness, nasal discharge, sneezing, nasal itching, and total eye symptoms by week and over four week double-blind period
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