AN EVALUATION OF THE EFFICACY AND SAFETY OF AZELASTINE IN PATIENTS WITH CHRONIC ASTHMA

Background: Azelastine, an oral nonsteroidal, antinflammatory drug wit h a good safety profile, has demonstrated relief of symptoms in patien ts with asthma. Objective: The study was designed to evaluate the effi cacy and safety of azelastine, a novel antiallergy compound, in patien ts with asthma who required maintenance therapy. Methods: During this 16-week, double-blind, randomized, parallel-group study, patients rece ived orally administered azelastine (4 mg twice daily), albuterol sulf ate (4 mg twice daily), or placebo. Results: Overall, patients in the azelastine group used 2.5 times less backup medication (p = 0.024) for relief of their asthma symptoms than patients in the placebo group. R eductions in asthma symptoms in the azelastine group were also noted t hroughout the double-blind treatment period. Moreover, the azelastine group had statistically significant improvements in FEV(1) after the f irst dose of medication. The only notable adverse experiences in the a zelastine group were alterations in taste perception and a small mean increase in body weight. Conclusion: Oral administration of azelastine to patients with asthma resulted in overall improvement in airway fun ction while reducing the requirement for adjunctive antiasthma medicat ions..