Fluticasone propionate aqueous nasal spray treatment for perennial allergic rhinitis in children.

BACKGROUND

Topical corticosteroid is now accepted as safe and most effective in controlling all symptoms of both allergic and nonallergic rhinitis. Fluticasone propionate aqueous nasal spray is a new once daily topical corticosteroid preparation.

OBJECTIVE

To evaluate the efficacy and safety of fluticasone propionate in children 5 to 11 years of age with perennial allergic rhinitis.

METHOD: A double-blind, placebo-controlled, parallel group of 127 recruited patients of whom 106 were evaluated. Treatment with once daily fluticasone propionate 100 micrograms or placebo for 4 weeks followed by a 2-week followup period. Fifty-three patients of each group were treated with fluticasone propionate or placebo by randomized assignment.

RESULTS

There was no statistical significance of the sex, mean age, weight, and height of the two groups. Patients treated with fluticasone propionate showed a significant decrease in total symptom scores rated by physicians at 2 weeks and 4 weeks, respectively (P < .01, P < .05). The rhinitis symptom scores in treatment group rated by patients (nasal blockage, sneezing, rhinorrhea) were significantly decreased at 2 weeks (P < .05, P < .01). Nasal symptoms as assessed by doctors (turbinate swelling, color of nasal mucosa, secretion, and postnasal drip) also decreased at 2 and 4 weeks, but were not statistically significant, except for the secretion at 2 weeks and postnasal drip at 4 weeks (P < .05). There was no evidence of effects on adrenal function by morning plasma cortisol concentration between the two groups.

CONCLUSION

Fluticasone propionate was safe and effective in children aged 5 to 11 years with perennial allergic rhinitis.