Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis.

Author(s): Maspero JF, Rosenblut A, Finn A Jr, Lim J, Wu W, Philpot E

Affiliation(s): Fundacion CIDEA, Allergy and Respiratory Research Unit, Buenos Aires, Argentina.

Publication date & source: 2008-01, Otolaryngol Head Neck Surg., 138(1):30-7.

Publication type:

OBJECTIVE: To evaluate the safety and efficacy of once-daily (QD) fluticasone furoate (FF) nasal spray in children with perennial allergic rhinitis (PAR). STUDY DESIGN: A global, randomized, double-blind, placebo-controlled study. SUBJECTS AND METHODS: Pediatric patients (aged 2-11 years; n = 558) with PAR received once-daily placebo, FF 110 mug, or FF 55 mug for 12 weeks. Efficacy was evaluated by nasal symptom scores. General safety and corticosteroid-specific safety (nasal and ophthalmic examinations, and hypothalamic-pituitary-adrenal assessments) were assessed. RESULTS: No findings of clinical concern were identified from the safety assessments. For primary efficacy analysis of mean change from baseline over the first 4 weeks of treatment in daily reflective total nasal symptom score, FF 55 mug demonstrated significant improvement (P = 0.003) compared with placebo; however, the improvement for FF 110 mug versus placebo did not reach statistical significance (P = 0.073). CONCLUSION: FF QD was well tolerated and demonstrated efficacy in children aged 2 to 11 years with PAR.