title: 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 <15 years were treated with FFNS 55μg, 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 55μg 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 55μg 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 55μg(18%) and placebo (19%).
  
  
  CONCLUSIONS
  Two-week treatment with FFNS 55μg, once daily is effective and tolerable in Japanese children aged 6 to <15 years with PAR.
authors: Department of Head & Neck and Sensory Organ Science, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
authors: Kimihiro
authors: K
authors: Okubo
authors: Development and Medical Affairs Division, GlaxoSmithKline K.K., Tokyo, Japan.
authors: Arisa
authors: A
authors: Okamasa
authors: Development and Medical Affairs Division, GlaxoSmithKline K.K., Tokyo, Japan.
authors: Gosuke
authors: G
authors: Honma
authors: Development and Medical Affairs Division, GlaxoSmithKline K.K., Tokyo, Japan.
authors: Masaki
authors: M
authors: Komatsubara
mesh_terms: D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007564:Japan; D008297:Male; D059085:Nasal Sprays; D012221:Rhinitis, Allergic, Perennial / Q000175:diagnosis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D059085:Nasal Sprays; C523187:fluticasone furoate