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Nasacort AQ

[Triamcinolone Acetonide]

CLINICAL TRIALS

The safety and efficacy of Nasacort AQ Nasal Spray have been evaluated in 10 double-blind, placebo-controlled clinical trials of two- to four-weeks duration in adults and children 12 years and older with seasonal or perennial allergic rhinitis. The number of patients treated with Nasacort AQ Nasal Spray in these studies was 1266; of these patients, 675 were males and 591 were females.

Overall, the results of these clinical trials in adults and children 12 years and older demonstrated that Nasacort AQ Nasal Spray 220 mcg once daily (2 sprays in each nostril), when compared to placebo, provides statistically significant relief of nasal symptoms of seasonal or perennial allergic rhinitis including sneezing, stuffiness, discharge, and itching. The safety and efficacy of Nasacort AQ Nasal Spray, at doses of 110 mcg or 220 mcg once daily, have also been adequately studied in two double-blind, placebo-controlled trials of two- and twelve-weeks duration in children ages 6 through 12 years with seasonal and perennial allergic rhinitis. These trials included 341 males and 177 females. Nasacort AQ administered at either dose resulted in statistically significant reductions in the severity of nasal symptoms of allergic rhinitis.

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