چکیده (انگلیسی):

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 mg, 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 mg improved nasal
symptom scores and rhinoscopy findings compared with the baseline. Ocular symptom scores were also
improved compared with the baseline in FFNS 55 mg in a sub-group of patients with any ocular symptoms
at baseline. FFNS 55 mg was shown to be well tolerated over the 12-week treatment period. Majority
of patients receiving FFNS 55 mg had unquantifiable plasma levels of fluticasone furoate (FF).
Conclusions: Twelve-week treatment with FFNS 55 mg, once daily, is well tolerated and effective with low
systemic exposure in Japanese children aged 2 to <15 years with PAR.