“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,” said clinical trial investigator Dr Bruce Martin from the Southwest Allergy and Asthma Clinical Research Department in San Antonio, Texas.
The data were presented at the Congress of the European Academy of Allergology and Clinical Immunology.
The phase II double blind study involved 641 hay fever patients over 12 years old. Patients were randomized to two weeks’ treatment with once daily, nasal administration of either placebo or one of 4 doses of Allermist (50, 100, 200 or 400 mcg).
The study’s primary endpoint was the mean change from baseline 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 mean change from baseline 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.
“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”, concluded Dr Martin.