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

• Published in: Allergy and asthma proceedings Vol. 29; no. 3; pp. 313 - 321
• Main Authors: Vasar, Maire, Houle, Pierre-Alain, Douglass, Jo Anne, Meltzer, Eli O., Silvey, MaryJane, Wu, Wei, Caldwell, Mark, Philpot, Edward
• Format: Journal Article
• Language: English
• Published: Providence, RI OceanSide Publications, Inc 01.05.2008; OceanSide Publications
• Subjects: Administration, Inhalation; Adolescent; Adult; Aged; Androstadienes - administration & dosage; Androstadienes - adverse effects; Child; Efficacy; Female; Fluticasone Furoate Nasal Spray; Humans; Intranasal Corticosteroid; Male; Middle Aged; Nasal Symptoms; Naso-Ocular Reflex; Nasolacrimal Duct - drug effects; Ocular Symptoms; Perennial Allergic Rhinitis; Quality Of Life; Randomized Controlled Trial; Rhinitis, Allergic, Perennial - drug therapy; Rhinitis, Allergic, Perennial - physiopathology; Safety; Spirometry; Surveys and Questionnaires; Treatment Outcome; Young Adult
• ISSN: 1088-5412; 1539-6304
• DOI: 10.2500/aap.2008.29.3126

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 μg 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 μg 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.