Methods: We evaluated the effects of Fluticasone Furoate (FF) 110 mcg given in the morning on Nasal Symptons (NS), DS, an CP in adults with symptomatic SAR during an allergy season. 40 adults ages 18-55 with a history of SAR and positive allergy skin tests to seasonal allergens. After a 1 week placebo (PL) run in, they randomly received either FF (21) or identical appearing PL (19) for 2 weeks. They recorded nasal sympton score (NSS) and Eppworth daytime sleepiness score (EDDS) for the 21 days, performed a TOVA test (Computerized test of cognitive performance) at day 7 and 21, and completed a nocturnal rhinoconjunctivitis quality of life questionnaire (NRQLQ) at days 7, 14 and 21. Average daily weekly scores, comparing week 1 baseline to week 3 were used for evaluation of NSS, and EDSS/ TOVA omissions, commissions and reaction times were compared, as was NRQLQ (day 7 and day 21).
Results: Mean total NSS (TNSS) instantaneous decreased from BL 12.88 to 10.84 in the FF group, and increased in PL group from 12.64 to 13.74 (P diff = .04). TNSS reflective decreased from 12.99 to 11.20 (FF group) and increased from 13.53 to 14.02 in PL. (P diff = NS). The mean EDSS decreased from 13.83 to 10.76 (P = .03) in FF group, and from 13.29 to 12.80 with PL (P dif = NS). TOVA commissin errors decreased by 7.13 (FF) vs 1.4 (PL) (P dif = .05). Omission increased in PL from 2.33 to 5.75, and 1.54 to 1.58 (FF) (P diff = NS). REaction time increased in both groups 363 to 391 millisecons (FF), 387 to 412 milliseconds (P = NS).
The FF reported a minimally clinical importance difference of 0.5 or greater on all 16 questions of NRQLQ, the PL group only in 10. (Mean change 1.01 (FF) vs .63 (PL) P = .004).
Conclusions: Treatment of symptomatic SAR with intranasal FF decrease daytime sleepiness, less nocturnal sleep disturbance, and improved cognitive performance.