Efficacy and safety of fluticasone furoate nasal spray in Chinese adult and adolescent subjects with intermittent or persistent allergic rhinitis.

摘要

Fluticasone furoate nasal spray (FFNS) is a novel, enhanced-affinity intranasal corticosteroid administered for the management of allergic rhinitis (AR). Several studies have shown that FFNS at a dose of 110 mug once daily (o.p.d.) is effective in relieving nasal as well as ocular symptoms in adolescents and adults with AR. The primary objective of this study was to compare the efficacy and safety of FFNS 110 micrograms o.p.d. with matching placebo nasal spray for 2 weeks in Chinese adult and adolescent subjects with intermittent AR (IAR) or persistent AR (PAR). In this multicenter, randomized, double-blind, placebo-controlled, parallel-group study, patients (adults and adolescents aged >/=12 years with AR) received either FFNS 110 micrograms (n = 181) or placebo (n = 182) o.p.d. for 2 weeks. AR was defined according to Allergic Rhinitis and Its Impact on Asthma classification. Efficacy measures included reflective total nasal symptom score (rTNSS), rhinoscopy score, overall interference in activities of daily living (ADL) score, and reflective total ocular symptom score (rTOSS). FFNS significantly improved the mean change from baseline in daily rTNSS compared with placebo (treatment difference of -1.498, 95% confidence interval [-1.897, -1.099]; p < 0.0001). FFNS was also significantly more effective than placebo in decreasing rhinoscopy score (treatment difference of -1.3; p < 0.0001) and ADL score (treatment difference of -0.4; p < 0.0001). In patients with severe ocular symptoms, FFNS showed numerically better treatment effect in reducing daily rTOSS than placebo (treatment difference of -0.646; p = 0.0853). FFNS 110 micrograms o.p.d. was significantly more effective than placebo in improving nasal symptoms in Chinese patients with IAR and PAR. ClinicalTrials.gov registration number: NCT01231464.