FLUTICASONE PROPIONATE AQUEOUS NASAL SPRAY IS SAFE AND EFFECTIVE FOR CHILDREN WITH SEASONAL ALLERGIC RHINITIS

Introduction. Fluticasone propionate aqueous nasal spray, a new topica l corticosteroid preparation, is effective when given as 200 mug once daily in patients (>12 years of age) with seasonal allergic rhinitis. Study objective. To evaluate the efficacy and safety of fluticasone pr opionate aqueous nasal spray in children aged 4 to 11 years with seaso nal allergic rhinitis. Study design. Multicenter, randomized, double-b lind, placebo-controlled, parallel-group. Patients. Two hundred fifty children aged 4 to 11 years with moderate-to-severe nasal symptoms, a positive skin test reaction to a late-summer or autumn allergen, a his tory of seasonal allergic rhinitis, and documentation of an unsatisfac tory response to conventional treatment. Interventions. Children were randomly assigned to receive fluticasone propionate, either 100 mug or 200 mug, or placebo, given by intranasal spray once daily in the morn ing for 14 days. Measurements and results. Severity of nasal symptoms (obstruction, rhinorrhea, itching, and sneezing) was recorded on visua l analog scales by investigators at weekly visits and by patients (or adult guardian) daily in the evening. According to investigator and pa tient ratings, both fluticasone propionate 100 mug/d and 200 mug/d low ered total nasal symptom scores when compared with placebo. Both dosag es of fluticasone propionate were more effective than placebo on the b asis of investigator-rated overall clinical evaluation of efficacy at the end of treatment, with significant improvement (as opposed to mode rate or mild improvement, no change or worsening) noted in 21% to 29% of the active-treatment groups vs 9% in the placebo group. There were no significant differences between the two fluticasone propionate dosa ges in any efficacy measurement. Morning plasma cortisol concentration s and frequency of drug-related adverse events were similar in the flu ticasone propionate and placebo groups. Conclusion. In children as you ng as 4 years, 100 mug of fluticasone propionate aqueous nasal spray g iven once daily is as effective as 200 mug given once daily, the usual adult dose for the treatment of seasonal allergic rhinitis. Both flut icasone propionate dosages were well tolerated and neither dosage appe ars to interfere with the hypothalamic-pituitary-adrenal axis in child ren.