An integrated analysis of the efficacy of fluticasone furoate nasal spray on
individual nasal and ocular symptoms of seasonal allergic rhinitis.
Author(s): Maspero JF, Walters RD, Wu W, Philpot EE, Naclerio RM, Fokkens WJ.
Affiliation(s): Fundacion Cidea, Paraguay 2035 Cuerpo 3°, Buenos Aires, Argentina.
Publication date & source: 2010, Allergy Asthma Proc. , 31(6):483-92
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.
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