THE EFFECTS OF TRIAMCINOLONE ACETONIDE AQUEOUS NASAL SPRAY ON ADRENOCORTICAL FUNCTION IN CHILDREN WITH ALLERGIC RHINITIS

Background: Suppression of adrenocortical function, a risk associated with oral corticosteroids, is minimized with intranasal corticosteroid s. Triamcinolone acetonide (TAA) aqueous nasal spray, at therapeutic d oses, has no measurable effect on adrenocortical function in adults wi th allergic rhinitis. Objective: This double-blind, placebo-controlled study compared the effect of once-daily TAA aqueous nasal spray (220 or 440 mu g) with placebo on adrenocortical function after 6 weeks of treatment in pediatric (children 6 to 12 years of age) patients with a llergic rhinitis. The pharmacokinetic profile of TAA was examined afte r once-daily intranasal administration of TAA aqueous nasal spray 440 mu g for 6 weeks. Methods: Eighty children received TAA aqueous nasal spray 220 mu g or 440 mu g or placebo for 6 weeks. Adrenocortical func tion was assessed by analyzing plasma cortisol levels before stimulati on (0 hour) and at 30 and 60 minutes after a rapid 1-hour intravenous cosyntropin stimulation test performed before treatment and after 6 we eks of treatment. Samples for pharmacokinetic evaluation were collecte d from 19 patients at baseline (0 hour) and at 0.5, 1, 1.5, and 6 hour s after the final dose of study medication. Results: After 6 weeks, no significant effects on adrenocortical function were observed at 30 or 60 minutes after cosyntropin stimulation with either dose of TAA aque ous nasal spray. TAA concentrations in plasma showed rapid elimination of the drug, with little or no accumulation. Conclusions: TAA aqueous nasal spray (220 or 440 mu g/day) has no measurable effect on adrenoc ortical function in pediatric patients with allergic rhinitis. Pharmac okinetic parameters after 440 mu g/day of TAA aqueous nasal spray indi cate a rapid decline of plasma drug levels, with little or no systemic accumulation of study drug.