TREATMENT OF SEASONAL ALLERGIC RHINITIS WITH ONCE-DAILY INTRANASAL FLUTICASONE PROPIONATE THERAPY IN CHILDREN

Purpose: To evaluate the efficacy and tolerability of intranasally adm inistered fluticasone propionate, 200 mu g or 100 mu g (half the adult dosage) when administered once daily for 4 weeks to children with sea sonal allergic rhinitis.Design and selling: Double-blind, randomized, placebo-controlled, parallel-group clinical study in 10 pediatric outp atient centers. Subjects: Children (n = 249), 4 to 11 years of age, wi th moderate to severe symptoms of seasonal allergic rhinitis, positive skin test reaction to a local autumn allergen, and a history of seaso nal allergic rhinitis. Measurements: Clinician- and patient-rated nasa l symptom scores (obstruction, rhinorrhea, sneezing, itching), clinici an-rated assessment of overall response to treatment, patient-rated na sal obstruction on awakening, and use of rescue medication. Clinicians questioned patients (or parents) regarding symptoms and adverse event s. Morning plasma cortisol concentrations and 24-hour urinary excretio n of cortisol and 17-ketogenic steroids were evaluated. Results: Intra nasal fluticasone propionate, 200 mu g or 100 mu g once daily, was sig nificantly more effective than placebo in the treatment of seasonal al lergic rhinitis in children. Clinician- and patient-rated symptom scor es indicated greater improvement in nasal symptoms, including nasal ob struction On awakening, among patients receiving intranasal fluticason e propionate. Overall response to treatment was also significantly gre ater in the active treatment groups. The two fluticasone propionate gr oups were not statistically different. Mean morning plasma cortisol co ncentrations and 24-hour urinary excretion of free cortisol and 17-ket ogenic steroids were similar across all groups both before and after t reatment. Conclusions: Intranasal fluticasone propionate, 100 mu g (ha lf the adult dose) or 200 mu g given once daily for 4 weeks is effecti ve and well tolerated in children 4 to II years of age with seasonal a llergic rhinitis.