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