Efficacy and safety of fluticasone furoate nasal spray in Japanese children with perennial allergic rhinitis: a multicentre, randomized, double-blind, placebo-controlled trial.

ABSTRACT Background: Fluticasone furoate nasal spray (FFNS) is a glucocorticoid developed for the treatment of allergic rhinitis (AR). This is the first randomized clinical trial to assess the efficacy and safety of FFNS in Japanese children with perennial AR (PAR). Methods: In this multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study, 261 children aged 6 to Results: Mean change from baseline over the entire treatment period in 3TNSS was greater in the FFNS 55 μg group compared with placebo, and the difference was statistically significant ( p 0. The incidence of adverse events was similar between FFNS 55 μg (18%) and placebo (19%). Conclusions: Two-week treatment with FFNS 55 μg, once daily is effective and tolerable in Japanese children aged 6 to