title: 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 > or =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 microg 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 microg q.d. was well tolerated and effective in reducing the nasal and ocular symptoms of PAR in adult and adolescent patients > or =12 years of age.
authors.affiliation: Children's Clinic, Tartu University, Tartu, Estonia. maire.vasar@kliinikum.ee
authors.forename: Maire
authors.initials: M
authors.lastname: Vasar
authors.forename: Pierre-Alain
authors.initials: PA
authors.lastname: Houle
authors.forename: Jo Anne
authors.initials: JA
authors.lastname: Douglass
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: Maryjane
authors.initials: M
authors.lastname: Silvey
authors.forename: Wei
authors.initials: W
authors.lastname: Wu
authors.forename: Mark
authors.initials: M
authors.lastname: Caldwell
authors.forename: Edward
authors.initials: E
authors.lastname: Philpot
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009301:Nasolacrimal Duct / Q000187:drug effects*; D011788:Quality of Life; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000503:physiopathology; D013147:Spirometry; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000730:Androstadienes; C523187:fluticasone furoate