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

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Abstract:

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 μg 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.

Keywords: ARIA classification; Allergic rhinitis; Chinese subjects; fluticasone furoate nasal spray (FFNS); interference in activities of daily living (ADL) score; intranasal corticosteroids; ocular symptoms; rhinoscopy score; total nasal symptoms score (TNSS); total ocular symptoms score (TOSS)

Document Type: Research Article

DOI: http://dx.doi.org/10.2500/aap.2011.32.3474

Publication date: November 1, 2011

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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