New data presented at the XXVth Congress of the European Academy of Allergology and Clinical Immunology (EAACI) show that the new, once-daily intranasal steroid (INS) Allermist/Avamys (fluticasone furoate) demonstrates statistically significant improvements in both the nasal and ocular symptoms of seasonal allergic rhinitis (SAR, hay fever).
"Existing intranasal steroids are effective against the nasal symptoms of allergic rhinitis. However, the relief of ocular symptoms remains a key unmet need for patients", points out clinical trial investigator Dr Bruce Martin from the Southwest Allergy and Asthma Clinical Research Department, San Antonio, Texas, USA. "Patients often resort to taking multiple medications and their satisfaction with current treatment is often low. The novel corticosteroid fluticasone furoate, with its effect on both nasal and ocular symptoms in an innovative, easy-to-use delivery system, may help address the real needs of allergic rhinitis patients."
The phase II double blind study involved 641 SAR patients over 12 years old1. Patients were randomised to two weeks' treatment with once daily, nasal administration of either placebo or one of 4 doses of fluticasone furoate (50, 100, 200 or 400 mcg). The study's primary endpoint was the mean change from baseline (MCFB) over the entire treatment period in patient-rated, daily reflective total nasal symptom score (aggregate of nasal congestion, itching, rhinorrhea and sneezing symptom scores). Secondary ocular endpoints included the MCFB in daily reflective total ocular symptom score (aggregate of eye itching/burning, tearing/watering and redness symptom scores). Drug safety was assessed by adverse events and laboratory tests.
All doses of fluticasone furoate significantly improved the nasal symptoms of SAR (p<0.001 vs. placebo). In addition, doses greater than 50 mcg significantly reduced ocular symptoms of SAR over the treatment period (p?0.013 vs. placebo). However, only the three highest doses of fluticasone furoate significantly reduced the pre-dose, instantaneous total ocular symptom score (p?0.019 vs. placebo). Across all doses the overall safety profile is positive and fluticasone furoate was well tolerated.
"Based on these findings, fluticasone furoate nasal spray 100 mcg once daily was considered to be the optimum dose to provide consistent and well tolerated relief of allergic rhinitis symptoms in adults and adolescents and will be used in the phase III development of this interesting and potentially useful new agent", concludes Dr Martin.
Fluticasone furoate (685698) is a novel, enhanced affinity steroid being developed by GlaxoSmithKline (GSK) for use in the treatment of allergic rhinitis as an intranasal spray. The new agent is currently in Phase III of development and both European and US filings are anticipated later this year.