AZELASTINE NASAL SPRAY IN THE MANAGEMENT OF SEASONAL ALLERGIC RHINITIS

Azelastine is a novel, investigational, antiallergy medication that in hibits the generation, release, and/or end-organ activity of multiple mediators of the inflammatory process in vitro and in vivo. Azelastine is capable of inhibiting both early-phase and late-phase allergic res ponses in animals and humans. In this 2-day trial in patients with sea sonal allergic rhinitis, we evaluated the onset of action, duration of effect, and safety and efficacy of azelastine nasal solution (Astelin N.S.) in an outdoor, highly allergenic environment. Two hundred ninet y-four patients who satisfied entry criteria were randomized to azelas tine 2 sprays/nostril q24h or q12h, oral chlorpheniramine maleate 12 m g q12h, or placebo in this multicenter, double-blind parallel-group st udy. Rhinitis symptoms were analyzed individually and combined as tota l and major symptom complexes. For both azelastine treatment groups, t he overall mean percent improvements in the total and major symptom co mplex severity scores were statistically significant (P less than or e qual to .05) versus placebo. Improvements in rhinitis symptoms were ob served by the second hour after administration of azelastine and laste d zip to 24 hours. The therapeutic effect of azelastine was apparent f or all rhinitis symptoms, not just one or a few symptoms. Seventy-thre e percent of the patients treated with azelastine reported overall imp rovement upon global assessment of their symptoms. Adverse effects wit h azelastine were generally mild or moderate Azelastine nasal spray, a dministered either once or twice daily, was effective in treating the symptoms of seasonal allergic rhinitis and demonstrated a rapid onset of action with a duration of response lasting 12 to 24 hours.