RATIONALE: Fluticasone Furoate Nasal Spray (FFNS), a new enhanced-affinity intranasal corticosteroid, was evaluated against oral fexofenadine (FEX) using the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) to further characterize its therapeutic profile.
METHODS: This was a randomized, double-blind, double-dummy, placebo-controlled, 2-week study (FFU109045) of 936 subjects with SAR who received either FFNS 110 mcg (312 subjects), fexofenadine 180 mg (311), or placebo (313) once-daily. The NRQLQ, a 16-item, self-administered, disease-specific, quality of life instrument that measures functional problems that are most troublesome to subjects with nocturnal allergy symptoms, was administered at randomization and at end of study. NRQLQ items are scored from 0 to 6, with higher scores indicating greater nocturnal impairment. Items are grouped into four domains: sleep problems; sleep time problems; symptoms on waking in the morning; and practical problems. An overall score is calculated from the mean score of all items. Mean change from baseline (MCFB) treatment differences in overall NRQLQ were analyzed using an analysis of covariance model.
RESULTS: Baseline NRQLQ global and individual domains scores were similar across treatment groups. MCFB differences in overall NRQLQ scores were significantly (p < 0.001) different with FFNS compared with placebo (-0.6, 95% CI -0.8, 0.1) and FEX (-0.5, 95% CI -0.7, -0.3) MCFB differences between FEX and placebo were not significantly different (-0.1, 95% CI -0.4, 0.1).
CONCLUSIONS: Subjects treated with FFNS had significant improvements in their rhinitis-related nocturnal quality of life compared with both FEX and placebo, while those treated with FEX did not show significant improvement over placebo.
