Abstract
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 μg, or FF 55 μg 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 μg demonstrated significant improvement (P = 0.003) compared with placebo; however, the improvement for FF 110 μg 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.
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