The efficacy and tolerability of fluticasone propionate aqueous nasal spray in children with seasonal allergic rhinitis.

Fluticasone propionate aqueous nasal spray (FPANS) contains fluticasone propionate, which is a new topically active glucocorticoid with approximately twice the potency of belcomethasone dipropionate. In this European multicentre study, 143 children with seasonal allergic rhinitis were recruited: 47 received FPANS 100 micrograms once a day (od), 46 received FPANS 200 micrograms od, and 50 patients received placebo od, for 4 weeks. Treatment efficacy was assessed using diary card nasal symptom scores for sneezing, rhinorrhoea, blockage and itching, and eye watering/irritation. Patients receiving FPANS 100 micrograms or FPANS 200 micrograms demonstrated statistically significant improvements in median nasal symptom scores in all the symptoms recorded, when compared with placebo. There were no statistically significant differences between the FPANS 100 micrograms and FPANS 200 micrograms groups in improvement in nasal symptom scores. There was no effect on eye watering/irritation symptoms which could be attributed to either FPANS 100 micrograms or FPANS 200 micrograms when compared with placebo. Use of rescue antihistamine medication was significantly reduced in the FPANS 100 micrograms group when compared with placebo. The adverse events profile was similar in all three treatment groups, and the events reported were generally mild and related to the patients' rhinitis.

RCT Entities:   Population Interventions Outcomes