title: An integrated analysis of the efficacy of fluticasone furoate nasal spray on individual nasal and ocular symptoms of seasonal allergic rhinitis.
abstract: Intranasal steroids have been shown to affect ocular symptoms of allergic rhinitis (AR). The results of the published literature, however, are not uniform across all products. This study was designed to evaluate whether the effects of fluticasone furoate nasal spray (FFNS) are consistent across different allergy seasons and different geographic regions for individual nasal and ocular symptoms of seasonal allergic rhinitis (SAR). An integrated analysis was performed on data from four randomized, double-blind, placebo-controlled, parallel-group, multicenter trials, designed to evaluate the efficacy and safety of FFNS, 110 micrograms, once daily for 14 days in 1141 adult and adolescent SAR patients exposed to mountain cedar, ragweed, or grass pollen allergen. All patients evaluated severity of seven individual nasal and ocular symptoms on a 4-point categorical scale. The main efficacy measures included change from baseline in daily reflective, morning (A.M.) predose instantaneous, and daily A.M. and evening (P.M.) reflective score for each nasal/ocular symptom. FFNS significantly improved daily mean reflective, A.M. predose instantaneous, and daily A.M. and P.M. reflective scores for nasal itching, sneezing, congestion, rhinorrhea, and ocular itching/burning, tearing/watering, and redness, compared with placebo (p < 0.001 for all versus placebo). The least square (LS) mean treatment differences ranged from -0.44 to -0.33 (p < 0.0001) for the individual nasal symptoms and from -0.22 to -0.19 (p < 0.0001) for the individual ocular symptoms. FFNS also significantly improved daily reflective total nasal symptom scores (TNSS)/reflective total ocular symptom scores (TOSS), and A.M. predose instantaneous TNSS and instantaneous TOSS, compared with placebo (LS mean treatment differences = -1.47, -0.65, -1.49, and -0.63, respectively; p < 0.001 for all). FFNS, 110 micrograms, once daily consistently relieved all nasal and ocular symptoms of SAR across different allergy seasons and geographical locations.
authors.affiliation: Fundacion Cidea, Paraguay 2035 Cuerpo 3°, Buenos Aires, Argentina.
authors.forename: Jorge F
authors.initials: JF
authors.lastname: Maspero
authors.forename: Richard D
authors.initials: RD
authors.lastname: Walters
authors.forename: Wei
authors.initials: W
authors.lastname: Wu
authors.forename: Edward E
authors.initials: EE
authors.lastname: Philpot
authors.forename: Robert M
authors.initials: RM
authors.lastname: Naclerio
authors.forename: Wytske J
authors.initials: WJ
authors.lastname: Fokkens
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000485:Allergens / Q000276:immunology; D031164:Ambrosia; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D052179:Antigens, Plant / Q000009:adverse effects / Q000276:immunology; D028203:Cedrus; D002648:Child; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D059085:Nasal Sprays; D011058:Pollen / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology*
chemical_list: D000485:Allergens; D000730:Androstadienes; D052179:Antigens, Plant; D059085:Nasal Sprays; C523187:fluticasone furoate