RATIONALE: Nighttime symptoms of SAR, particularly congestion, may reduce quality and quantity of sleep. Fluticasone furoate nasal spray (FFNS), a new enhanced-affinity intranasal corticosteroid, and oral fexofenadine (FEX), a non-sedating antihistamine, were compared using a validated nighttime symptom questionnaire (NSS), subject-rated nasal symptoms, and peak nasal inspiratory flow (PNIF), an objective measure of nasal obstruction.
METHODS: Subjects with SAR (n = 936) received either FFNS 110 mcg (312), fexofenadine 180 mg (311), or placebo (313) once daily for 2 weeks in this randomized, double-blind, double-dummy study (FFU109045). The primary endpoint was the mean change from baseline (MCFB) over the treatment period in the NSS, which assesses nasal congestion on awakening, nighttime awakenings, and difficulty going to sleep. Supportive secondary endpoints included MCFB in 12-hour daytime and nighttime reflective total nasal symptom scores, instantaneous nasal symptoms scored each morning prior to dosing, and morning and evening PNIF measurements. No formal comparisons of nasal scores and PNIF were originally undertaken.
RESULTS: Significant differences (p < 0.001) were seen between FFNS compared with both FEX and placebo in the MCFB in NSS and all nasal symptom scores, while no significant differences were seen between FEX and placebo. Both morning and evening PNIF results showed a similar response pattern, with significant increases in nasal inspiratory airflow between FFNS compared with both FEX and placebo (p < 0.001), but not between FEX and placebo.
CONCLUSIONS: Compared with FEX and placebo, FFNS significantly improved nasal symptoms (including nasal congestion, itching, sneezing, and rhinorrhea) and congestion-related nighttime symptoms of SAR with a corresponding significant increase in PNIF.
