Efficacy and Safety of Fluticasone Furoate Nasal Spray in Japanese Children with Perennial Allergic Rhinitis: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial

摘要

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 15 years were treated with FFNS 55 μg, once daily or placebo for two weeks. Nasal and ocular symptoms were rated by parents/guardians/patients in the patient daily diary. The primary endpoint was the mean change from baseline in the three total nasal symptom score (3TNSS). In addition, rhinoscopic findings were rated by the investigators as an efficacy measure. As a safety measure, adverse events and clinical chemistry and hematology were evaluated. 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 0.001). Significant improvements in rhinoscopic findings of swelling of inferior turbinate mucosa and quantity of nasal discharge were also observed. The total ocular symptom score (TOSS) was reduced significantly in the FFNS 55 μg group, compared with placebo, in the second week in a subgroup of patients with baseline TOSS 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 15 years with PAR.