THE EFFECTIVENESS OF ORAL AZELASTINE IN THE MANAGEMENT OF PERENNIAL ALLERGIC RHINITIS

Azelastine, a phthalazinone derivative, is a chemically navel antialle rgy compound that inhibits inflammatory responses in the upper and low er airway. Previous clinical trials demonstrated the effectiveness of azelastine in the treatment of allergic rhinitis. The objective of thi s double-blind trial was to further evaluate the efficacy and safety o f oral azelastine compared with placebo in patients with perennial all ergic rhinitis. A total of 192 patients (between 13 and 60 years of ag e) who satisfied a minimum symptom scope 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 pri mary efficacy analysis, rhinitis symptoms were analyzed as a Total Sym ptom Complex severity score (nose blows, runny nose, sneezes, stuffy n ose, itchy nose, and itchy eyes/ears/throat). After 2 and 4 weeks of t herapy, the azelastine group had greater mean percent improvements tha n the placebo group in the Total Symptom Complex severity scores. The overall and endpoint improvements for the azelastine group were statis tically significant (P less than or equal to .026) versus placebo. Imp rovements in individual rhinitis symptoms for the azelastine group wer e 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 toler ated. The results support oval azelastine's safety and effectiveness i n the treatment of perennial allergic rhinitis.