Fluticasone furoate nasal spray is more effective than fexofenadine for nighttime symptoms of seasonal allergy

被引:31
作者
Andrews, Charles P. [1 ]
Martin, Bruce G. [2 ]
Jacobs, Robert L. [3 ]
Mohar, Dale E. [4 ]
Diaz, Joseph D. [5 ]
Amar, Niran J. [6 ]
Kaiser, Harold B. [7 ]
Vandewalker, Mark L. [8 ]
Bernstein, Jonathan [9 ]
Toler, William T. [10 ]
Prillaman, Barbara A. [10 ]
Dalal, Anand A. [10 ]
Lee, Laurie A. [10 ]
Philpot, Edward E. [10 ]
机构
[1] Diagnost Res Grp, San Antonio, TX USA
[2] SW Allergy & Asthma Ctr, San Antonio, TX USA
[3] Biogenics Res Inst, San Antonio, TX USA
[4] Kerrville Allergy & Asthma Associates, Kerrville, TX USA
[5] Allergy & Asthma Res Ctr PA, San Antonio, TX USA
[6] Allergy Asthma Res Inst, Waco, TX USA
[7] Clin Res Inst, Minneapolis, MN USA
[8] Clin Res Ozarks, Columbia, MO USA
[9] Bernstein Clin Res Ctr, Cincinnati, OH USA
[10] GlaxoSmithKline, Res Triangle Pk, NC USA
关键词
Allergy; antihistamine; fexofenadine; fluticasone furoate; intranasal corticosteroid; nasal symptoms; NRQLQ; ocular symptoms; rhinitis; seasonal allergic rhinitis; sleep; QUALITY-OF-LIFE; INTRANASAL CORTICOSTEROIDS; DAYTIME SOMNOLENCE; OCULAR SYMPTOMS; STEROID BUDESONIDE; SLEEP DISTURBANCE; RHINITIS; EFFICACY; SAFETY; PROPIONATE;
D O I
10.2500/aap.2009.30.3204
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
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 mu g (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 <= 0.001) in study 1 and more effective than both placebo and fexofenadine (p <= 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. (Allergy Asthma Proc 30:128-138, 2009; doi: 10.2500/aap.2009.30.3204)
引用
收藏
页码:128 / 138
页数:11
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