Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension.

BACKGROUND: Intranasal corticosteroids (INSs) are the most effective treatment for allergic rhinitis (AR). However, available INS safety and efficacy data in children younger than 6 years are limited.

OBJECTIVE: To report the first well-controlled study assessing the safety and efficacy of an INS in children aged 2 to 5 years with perennial AR.

METHODS: In a 4-week, multicenter, double-blind, parallel-group study, patients were randomized to receive triamcinolone acetonide aqueous nasal spray (TAA AQ), 110 microg once daily, or placebo. A subset of children continued into a 6-month, open-label phase. Efficacy end points included total nasal symptom scores. Safety measures included reports of adverse events, morning serum cortisol levels before and after cosyntropin infusion, and growth as measured using office stadiometry.

RESULTS: A total of 474 patients were randomized to receive TAA AQ (n = 236) or placebo (n = 238); 436 entered the open-label extension phase. Adjusted mean (SE) changes from baseline during the double-blind period in instantaneous and reflective total nasal symptom scores were -2.28 (0.16) and -2.31 (0.15), respectively, in the TAA AQ group (P = .09) vs -1.92 (0.16) and -1.87 (0.15) in the placebo group (P = .03). Adverse event rates were comparable between treatment groups. There was no significant change from baseline in serum cortisol levels after cosyntropin infusion at study end. The distribution of children by stature-for-age percentile remained stable during the study.

CONCLUSIONS: Use of TAA AQ, 110 microg once daily, for up to 6 months offers a favorable efficacy to safety ratio in children aged 2 to 5 years with perennial AR.