Azelastine nasal spray as adjunctive therapy to azelastine tablets in the management of seasonal allergic rhinitis

Background: Azelastine rhinitis medications (nasal spray and tablets) have been shown to relieve the symptoms of allergic rhinitis. Nevertheless, many rhinitic subjects suffer from acute exacerbations of symptoms that sometimes require additional treatment. Objective: To assess the efficacy and safety of azelastine nasal spray as adjunctive therapy to azelastine tablets in the management of symptomatic seasonal allergic rhinitis in subjects who remain symptomatic despite the oral medication. Methods: A 2-day, randomized, multicenter, double-blind, placebo-controlled, parallel-group study. Two hundred thirty-three subjects with symptomatic allergic rhinitis received azelastine tablets (0.5 mg bid) for a minimum of seven days prior to receiving either azelastine nasal spray (2 sprays per nostril bid) or placebo nasal spray as adjunctive therapy. Efficacy was determined by improvement in rhinitis symptoms that were grouped according to total and major symptom complex severity scores. Results: Mean percent improvements in the total symptom complex severity scores for azelastine were statistically significant (P less than or equal to.05) or showed a trend toward statistical significance (.05 less than or equal to P <.10) versus placebo from the second through the first ten hours after the initial dose and for each of the last five hours of the second day, demonstrating a rapid onset of action and sustained efficacy over the 2-day study period. Azelastine was well tolerated, and no subject discontinued therapy with azelastine due to an adverse experience. Conclusion: Azelastine nasal spray can be effectively administered as adjunctive therapy, in an outdoor environment in which subjects are exposed to pollen and other aeroallergens.