Randomized Double-Blind, Placebo-Controlled Clinical Trial of a Selective 5-Lipoxygenase Inhibitor (AA-861) for the Prevention of Seasonal Allergic Rhinitis

Abstract

In a randomized, double-blind, parallel group trial conducted in eight European centres, the 5-lipoxygenase inhibitor AA-861 was administered orally, starting 2 weeks before the pollen season and continuing for 8 weeks; after the start of the season escape medication was permitted if necessary. Patients were enrolled who had a previous history of pollen allergy, confirmed by skin prick tests and/or relevant allergen-specific immunoglobulin E to pollen. Daily symptoms scores were recorded on diary cards and assessments were made by the investigator during the study period. Better global improvement ratings were achieved using AA-861, as assessed both by the investigators and the patients. The total nasal symptoms scores and activities of daily living were also improved compared to placebo. No significant adverse reactions were encountered.