title: Fluticasone furoate nasal spray is more effective than fexofenadine for nighttime symptoms of seasonal allergy.
abstract: Nasal symptoms of allergic rhinitis are an important cause of sleep disturbance. Reduction of nasal symptoms, particularly nasal obstruction, has been linked to improvements in self-reported sleep quality. The enhanced-affinity intranasal corticosteroid fluticasone furoate and the oral antihistamine fexofenadine were compared with respect to nighttime symptoms of seasonal allergic rhinitis. In two randomized, double-blind, double-dummy, parallel-group studies, patients received fluticasone furoate nasal spray (FFNS),110 microg (study 1, n = 312; study 2, n = 224); fexofenadine, 180 mg (study 1, n = 311; study 2, n = 227); or placebo (study 1, n = 313; study 2, n = 229) once daily for 2 weeks. Fluticasone furoate was more effective (p < 0.001) than fexofenadine and placebo in both studies with respect to the mean changes from baseline over the treatment period in the nighttime symptoms score, nighttime reflective total nasal symptom score, predose instantaneous nasal symptom score, and morning peak nasal inspiratory flow. Fluticasone furoate was more effective than placebo (p <or= 0.001) in study 1 and more effective than both placebo and fexofenadine (p <or= 0.034) in study 2 with respect to the mean changes from baseline in the nighttime reflective total ocular symptom score and predose instantaneous total ocular symptom score. In these double-dummy studies, fexofenadine did not separate from placebo in comparisons of the nighttime symptoms score or the nighttime nasal or ocular symptom measures. The incidence of adverse events was similar among groups. FFNS once daily was more effective than fexofenadine and placebo with respect to nighttime sleep disturbance caused by seasonal allergy symptoms.
authors.affiliation: Diagnostics Research Group, San Antonio, Texas, USA. dr.andrews@dxrg.com
authors.forename: Charles P
authors.initials: CP
authors.lastname: Andrews
authors.forename: Bruce G
authors.initials: BG
authors.lastname: Martin
authors.forename: Robert L
authors.initials: RL
authors.lastname: Jacobs
authors.forename: Dale E
authors.initials: DE
authors.lastname: Mohar
authors.forename: Joseph D
authors.initials: JD
authors.lastname: Diaz
authors.forename: Niran J
authors.initials: NJ
authors.lastname: Amar
authors.forename: Harold B
authors.initials: HB
authors.lastname: Kaiser
authors.forename: Mark L
authors.initials: ML
authors.lastname: Vandewalker
authors.forename: Jonathan
authors.initials: J
authors.lastname: Bernstein
authors.forename: William T
authors.initials: WT
authors.lastname: Toler
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Prillaman
authors.forename: Anand A
authors.initials: AA
authors.lastname: Dalal
authors.forename: Laurie A
authors.initials: LA
authors.lastname: Lee
authors.forename: Edward E
authors.initials: EE
authors.lastname: Philpot
mesh_terms: D000281:Administration, Intranasal; D000284:Administration, Oral; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006633:Histamine Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D015508:Nasal Obstruction / Q000188:drug therapy; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology; D016593:Terfenadine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D006633:Histamine Antagonists; D016593:Terfenadine; C093230:fexofenadine; C523187:fluticasone furoate