Fluticasone furoate nasal spray is more effective than fexofenadine for nighttime symptoms of seasonal allergy.
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.
Andrews
Charles P
CP
Diagnostics Research Group, San Antonio, Texas, USA. dr.andrews@dxrg.com
Martin
Bruce G
BG
Jacobs
Robert L
RL
Mohar
Dale E
DE
Diaz
Joseph D
JD
Amar
Niran J
NJ
Kaiser
Harold B
HB
Vandewalker
Mark L
ML
Bernstein
Jonathan
J
Toler
William T
WT
Prillaman
Barbara A
BA
Dalal
Anand A
AA
Lee
Laurie A
LA
Philpot
Edward E
EE
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
D000730:Androstadienes; D006633:Histamine Antagonists; D016593:Terfenadine; C093230:fexofenadine; C523187:fluticasone furoate