Abstract
Triamcinolone acetonide (TAA) Aqueous nasal inhaler is an effective and well-tolerated treatment for the symptoms associated with seasonal allergic rhinitis (SAR). This study compared the safety and efficacy of once-daily administration of TAA Aqueous nasal inhaler (110 μg and 220 μg) with placebo in a pediatric population with spring-grass SAR. Two hundred and twenty-three patients (6-11 years of age) were evaluated in this randomized, placebo-controlled, double-blinded trial. Patients received TAA Aqueous nasal inhaler (110 μg or 220 μg) or placebo once daily for 2 weeks. Rhinitis symptoms (nasal stuffiness, discharge, sneezing, nasal index, nasal itching, and eye symptoms) were evaluated and recorded daily. Both TAA Aqueous nasal inhaler dosages were more effective than placebo in relieving the symptoms of SAR over the 2-week treatment period. Patients in the 110-μg group had significantly (P < 0.05) greater mean reductions in nasal stuffiness, nasal discharge, and nasal index compared to placebo after week 1, week 2, and overall. Patients who received TAA Aqueous nasal inhaler 220 μg had significantly (P < 0.05) larger mean reductions in nasal stuffiness after week 1, week 2, and overall, compared to placebo, with significant (P = 0.034) improvements in nasal stuffiness as early as day 1. Patient and physician satisfaction effects with both TAA Aqueous nasal inhaler regimens was low and comparable with placebo. This double-blinded, placebo-controlled trial demonstrated that TAA Aqueous nasal inhaler (110 μg and 220 μg per day) was well tolerated and reduced spring grass SAR symptoms significantly in children.
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