PURPOSE: To evaluate the efficacy and tolerability of intranasally administered fluticasone propionate, 200 micrograms or 100 micrograms (half the adult dosage) when administered once daily for 4 weeks to children with seasonal allergic rhinitis. DESIGN AND SETTING: Double-blind, randomized, placebo-controlled, parallel-group clinical study in 10 pediatric outpatient centers. SUBJECTS:Children (n = 249), 4 to 11 years of age, with moderate to severe symptoms of seasonal allergic rhinitis, positive skin test reaction to a local autumn allergen, and a history of seasonal allergic rhinitis. MEASUREMENTS: Clinician- and patient-rated nasal symptom scores (obstruction, rhinorrhea, sneezing, itching), clinician-rated assessment of overall response to treatment, patient-rated nasal obstruction on awakening, and use of rescue medication. Clinicians questioned patients (or parents) regarding symptoms and adverse events. Morning plasma cortisol concentrations and 24-hour urinary excretion of cortisol and 17-ketogenic steroids were evaluated. RESULTS:Intranasal fluticasone propionate, 200 micrograms or 100 micrograms once daily, was significantly more effective than placebo in the treatment of seasonal allergic rhinitis in children. Clinician- and patient-rated symptom scores indicated greater improvement in nasal symptoms, including nasal obstruction on awakening, among patients receiving intranasal fluticasone propionate. Overall response to treatment was also significantly greater in the active treatment groups. The two fluticasone propionate groups were not statistically different. Mean morning plasma cortisol concentrations and 24-hour urinary excretion of free cortisol and 17-ketogenic steroids were similar across all groups both before and after treatment. CONCLUSIONS:Intranasal fluticasone propionate, 100 micrograms (half the adult dose) or 200 micrograms given once daily for 4 weeks is effective and well tolerated in children 4 to 11 years of age with seasonal allergic rhinitis.
RCT Entities:
PURPOSE: To evaluate the efficacy and tolerability of intranasally administered fluticasone propionate, 200 micrograms or 100 micrograms (half the adult dosage) when administered once daily for 4 weeks to children with seasonal allergic rhinitis. DESIGN AND SETTING: Double-blind, randomized, placebo-controlled, parallel-group clinical study in 10 pediatric outpatient centers. SUBJECTS:Children (n = 249), 4 to 11 years of age, with moderate to severe symptoms of seasonal allergic rhinitis, positive skin test reaction to a local autumn allergen, and a history of seasonal allergic rhinitis. MEASUREMENTS: Clinician- and patient-rated nasal symptom scores (obstruction, rhinorrhea, sneezing, itching), clinician-rated assessment of overall response to treatment, patient-rated nasal obstruction on awakening, and use of rescue medication. Clinicians questioned patients (or parents) regarding symptoms and adverse events. Morning plasma cortisol concentrations and 24-hour urinary excretion of cortisol and 17-ketogenic steroids were evaluated. RESULTS: Intranasal fluticasone propionate, 200 micrograms or 100 micrograms once daily, was significantly more effective than placebo in the treatment of seasonal allergic rhinitis in children. Clinician- and patient-rated symptom scores indicated greater improvement in nasal symptoms, including nasal obstruction on awakening, among patients receiving intranasal fluticasone propionate. Overall response to treatment was also significantly greater in the active treatment groups. The two fluticasone propionate groups were not statistically different. Mean morning plasma cortisol concentrations and 24-hour urinary excretion of free cortisol and 17-ketogenic steroids were similar across all groups both before and after treatment. CONCLUSIONS: Intranasal fluticasone propionate, 100 micrograms (half the adult dose) or 200 micrograms given once daily for 4 weeks is effective and well tolerated in children 4 to 11 years of age with seasonal allergic rhinitis.