title: Safety and efficacy of fluticasone furoate nasal spray in Japanese children 2 to <15 years of age with perennial allergic rhinitis: a multicentre, open-label trial.
abstract: BACKGROUND
  Fluticasone furoate nasal spray (FFNS) is a glucocorticoid developed for the treatment of allergic rhinitis (AR). This study aimed to assess the safety, efficacy, and systemic exposure of FFNS in Japanese children with perennial AR (PAR).
  
  
  METHODS
  In this multicentre, open-label, phase 3 study, 61 children aged 2 to <15 years were treated with FFNS 55 μg, once daily for 12 weeks. Nasal and ocular symptoms were scored by parents/guardians/patients and recorded in a patient's daily diary. In addition, rhinoscopy findings, including mucosal swelling, were scored by the investigators as an efficacy measure. As a safety measure, adverse events and clinical laboratory data were evaluated.
  
  
  RESULTS
  An adverse event was reported by 67% of patients during the treatment and follow-up period, all of which were mild in intensity. The most commonly reported adverse events were nasopharyngitis and acute sinusitis (acute rhinosinusitis). There were no serious adverse events. FFNS 55 μg improved nasal symptom scores and rhinoscopy findings compared with the baseline. Ocular symptom scores were also improved compared with the baseline in FFNS 55 μg in a sub-group of patients with any ocular symptoms at baseline. FFNS 55 μg was shown to be well tolerated over the 12-week treatment period. Majority of patients receiving FFNS 55 μg had unquantifiable plasma levels of fluticasone furoate (FF).
  
  
  CONCLUSIONS
  Twelve-week treatment with FFNS 55 μg, once daily, is well tolerated and effective with low systemic exposure in Japanese children aged 2 to <15 years with PAR.
authors.affiliation: Department of Head & Neck and Sensory Organ Science, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan. Electronic address: ent-kimi@nms.ac.jp.
authors.forename: Kimihiro
authors.initials: K
authors.lastname: Okubo
authors.affiliation: Development and Medical Affairs Division, GlaxoSmithKline K.K., Tokyo, Japan.
authors.forename: Arisa
authors.initials: A
authors.lastname: Okamasa
authors.affiliation: Development and Medical Affairs Division, GlaxoSmithKline K.K., Tokyo, Japan.
authors.forename: Gosuke
authors.initials: G
authors.lastname: Honma
authors.affiliation: Development and Medical Affairs Division, GlaxoSmithKline K.K., Tokyo, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Komatsubara
mesh_terms: D000293:Adolescent; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D044466:Asian People; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D059085:Nasal Sprays; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000276:immunology*; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D059085:Nasal Sprays; C523187:fluticasone furoate
keywords: Children; Fluticasone furoate; Perennial allergic rhinitis; Pharmacokinetics; Safety