Fluticasone furoate nasal spray: Effective monotherapy for symptoms of perennial allergic rhinitis in adults/adolescents

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Abstract:

Intranasal corticosteroids are widely prescribed for the treatment of perennial allergic rhinitis (PAR). The purpose of this study was to evaluate the efficacy and tolerability of intranasal fluticasone furoate, a novel enhanced-affinity glucocorticoid, in patients ≥12 years of age with PAR in a global, randomized, double-blind, placebo-controlled, 6-week study. Patients (n = 302) received fluticasone furoate nasal spray (FFNS) 110 g or vehicle placebo once daily (q.d.). The primary efficacy measure was mean change from baseline over the 6-week treatment period in daily reflective total nasal symptom score (TNSS). Secondary end points included mean change from baseline in total and individual reflective nasal and ocular symptom scores and in daily peak nasal inspiratory flow (PNIF). FFNS was significantly more effective than placebo in reducing daily reflective TNSS over the treatment period (least square [LS] mean difference, −1.256; p < 0.001). Significant improvements were also established in total ocular symptom score (LS mean difference, −0.506; p = 0.004 versus placebo) and in all individual nasal (p < 0.001) and ocular (p < 0.03) symptoms assessed in a reflective manner. Improvements in daily PNIF were significantly greater with FFNS than placebo (LS mean difference, 8.376 L/minute; p = 0.004). FFNS was well tolerated. In this study, FFNS 110 g q.d. was well tolerated and effective in reducing the nasal and ocular symptoms of PAR in adult and adolescent patients ≥12 years of age.

Keywords: Efficacy; fluticasone furoate nasal spray; intranasal corticosteroid; nasal symptoms; naso-ocular reflex; ocular symptoms; perennial allergic rhinitis; quality of life; randomized controlled trial; safety

Document Type: Research Article

DOI: http://dx.doi.org/10.2500/aap.2008.29.3126

Affiliations: 1: Children's Clinic, Tartu University, Tartu, Estonia 2: Sir Mortimer B. Davis–Jewish General Hospital, Montreal, Quebec, Canada 3: Department of Allergy, Immunology and Respiratory Medicine (AIRmed), Alfred Hospital and Monash University, Melbourne, Australia 4: Allergy and Asthma Medical Group and Research Center, San Diego, California 5: Research and Development, GlaxoSmithKline, Research Triangle Park, North Carolina 6: Respiratory Medicines Development Centre, GlaxoSmithKline, Stockley Park, United Kingdom

Publication date: May 1, 2008

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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