The Effectiveness of Oral Azelastine in the Management of Perennial Allergic Rhinitis

Abstract

Azelastine, a phthalazinone derivative, is a chemically novel antiallergy compound that inhibits inflammatory responses in the upper and lower airway. Previous clinical trials demonstrated the effectiveness of azelastine in the treatment of allergic rhinitis. The objective of this double-blind trial was to further evaluate the efficacy and safety of oral azelastine compared with placebo in patients with perennial allergic rhinitis. A total of 192 patients (between 13 and 60 years of age) who satisfied a minimum symptom score during a single-blind placebo evaluation period were randomized to receive one of three treatments: 2 mg of azelastine b.i.d., 1.34 mg of clemastine fumarate b.i.d., or placebo b.i.d. for a 4-week double-blind treatment period. In the primary efficacy analysis, rhinitis symptoms were analyzed as a Total Symptom Complex severity score (nose blows, runny nose, sneezes, stuffy nose, itchy nose, and itchy eyes/ears/throat). After 2 and 4 weeks of therapy, the azelastine group had greater mean percent improvements than the placebo group in the Total Symptom Complex severity scores. The overall and endpoint improvements for the azelastine group were statistically significant (P ≤ .026) versus placebo. Improvements in individual rhinitis symptoms for the azelastine group were superior to placebo for nose blows, runny nose, sneezes, itchy nose, and itchy eyes/ears/throat. Azelastine was well tolerated. Clemastine was also significantly more effective than placebo and was well tolerated. The results support oral azelastine's safety and effectiveness in the treatment of perennial allergic rhinitis.