Fluticasone Furoate Nasal Spray Demonstrates Consistent Efficacy in Seasonal Allergic Rhinitis: Presented at EAACI
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Fluticasone Furoate Nasal Spray Demonstrates Consistent Efficacy in Seasonal Allergic Rhinitis: Presented at EAACI

By Judith Moser, MD

WARSAW, Poland -- June 9, 2009 -- Fluticasone furoate nasal spray (FFNS) 110 mcg once daily showed a marked and consistent beneficial effect on individual nasal symptoms in a large patient population with seasonal allergic rhinitis, researchers stated here at the 28th Congress of the European Academy of Allergy and Clinical Immunology (EAACI).

FFNS proved effective in adolescent and adult patients with seasonal allergic rhinitis in 4 randomised, double-blind, placebo-controlled trials. The allergies of the participants were caused by a variety of allergens in different geographical regions.

Paul Keith, MD, Division of Allergy and Clinical Immunology, McMaster University, Hamilton, Ontario, presented an analysis of the individual total nasal symptom scores (TNSS) of the 4 trials at a poster presentation session here on June 8.

As Dr. Keith indicated, the objective of the study was to analyse the magnitude and consistency of the effect of the nasal spray on each of the components of the TNSS: rhinorrhoea, nasal congestion, nasal itching, and sneezing.

"Many guidelines recommend the use of an antihistamine for itch and discharge and the use of nasal steroids for congestion," Dr. Keith said. "But this analysis shows that there is a very significant benefit for all of those symptoms regardless of whether it is the ragweed season, the grass season, or the tree pollen season."

In all 4 studies, FFNS 110 mcg once daily (n = 571) was assessed in comparison with placebo (n = 570). The trials employed other doses as well, but the data used for this analysis are those for the 110-mcg dosage.

Individual nasal symptoms were recorded as reflective nasal symptom scores (rNSS), indicating how a patient felt during the previous 12 hours, or instantaneous nasal symptom scores (iNSS), the symptoms at the time of assessment.

As compared with placebo, FFNS showed a significantly greater efficacy (P < .001) for the mean change from baseline in 3 of the trials for all individual rNSS and iNSS.

FFNS was significantly more effective than placebo in improving the reflective TNSS in all 4 studies (P <= .003). In the integrated analysis of the adolescent population, the spray treatment resulted in a mean change of -3.5 compared with -1.9 for placebo. This confirms previous assertions that FFNS is effective in adolescents.

In 2 of the studies, the onset of the effect was observed as early as 8 hours after the initial administration.

The nasal spray had a favourable safety and tolerability profile across all trials.

Dr. Keith underscored the magnitude of the clinical benefit gained by the use of FFNS, noting that this can be illustrated by comparing the differences with those seen with the other nasal steroids currently available.

Funding for this study was provided by GlaxoSmithKline.

Presentation Title: Fluticasone Furoate Nasal Spray Improves the Individual Nasal Symptoms (Rhinorrhea, Nasal Congestion, Nasal Itching, Sneezing) of Seasonal Allergic Rhinitis Across Four Studies. Abstract 296


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