SAFETY AND EFFICACY OF AZELASTINE NASAL SPRAY (ASTELIN NS) FOR SEASONAL ALLERGIC RHINITIS - A 4-WEEK COMPARATIVE MULTICENTER TRIAL

Background: Azelastine is a chemically novel investigational antialler gy drug with the ability to antagonize the effects of chemical mediato rs of the early-phase and late-phase allergic responses suggesting its usefulness in the treatment of upper and lower airway diseases. Objec tive: The objective of this 4-week, double-blind, multicenter trial wa s to evaluate the efficacy of azelastine nasal spray in subjects with seasonal allergic rhinitis. Methods: Two hundred sixty-four subjects 1 2 years of age and older were randomized to receive either azelastine, 2 sprays/nostril qd; azelastine, 2 sprays/nostril bid; oral chlorphen iramine maleate, 12 mg bid; or placebo. The primary efficacy parameter s were the changes in major and total symptom complex severity scores. Results: Overall, across all 4 weeks of treatment, the mean percent i mprovements in the total and major symptom complex severity scores in both azelastine treatment groups were greater than those for the place bo group. For the azelastine 2 sprays bid group, the overall results w ere significant at P less than or equal to .05 for the major symptom c omplex score and at .05 < P less than or equal to .10 for the total sy mptom complex score versus placebo. For both azelastine treatment grou ps, improvements in all of the individual rhinitis symptoms were super ior to those for the placebo group and, in general were clinically and statistically significant. Azelastine nasal spray was well tolerated; adverse experiences were generally application site reactions, mild t o moderate, and not limiting to continued treatment. Conclusions: Azel astine nasal spray demonstrated broad clinical antirhinitis activity t hat for the 2 sprays/nostril bid dosage regimen was consistently clini cally and statistically significant.