DOUBLE-BLIND ASSESSMENT OF AZELASTINE IN THE TREATMENT OF PERENNIAL ALLERGIC RHINITIS

Azelastine is a chemically novel multifunctional antiallergy investiga tional drug capable of inhibiting mast-cell activation and the synthes is and/or release of chemical mediators of the upper and lower airway inflammatory response. In previous controlled clinical trials, azelast ine was shown to be effective in treating the symptoms of both seasona l allergic rhinitis and perennial allergic rhinitis. The objective of this 8-week double-blind trial was to evaluate further azelastine's ef ficacy and safety in improving the symptoms of perennial allel gic rhi nitis over a prolonged period of treatment. One hundred ninety-nine pa tients with symptomatic perennial allergic rhinitis were randomized to receive in a double-blind fashion azelastine, 2 mg bid, clemastine fu marate, 1.34 mg bid, or placebo bid for 8 weeks. Patients treated with azelastine had superior mean percent improvements in the total sympto m complex score (nose blows, sneezes, stuffy nose, runny nose, itchy n ose, and itchy eyes/ears/throat) versus placebo at each evaluation poi nt and overall across all 8 weeks (P < .01) of the trial. Improvements in the individual symptoms of rhinitis were statistically significant (P less than or equal to .04) for nose blows, sneezes, runny nose, it chy nose, and itchy eyes, ears, and throat. Treatment with azelastine also resulted in a clinically meaningful improvement in nasal congesti on. Improvement in congestion was accompanied by a decreased requireme nt for backup decongestant medication. The adverse experiences were ge nerally mild and well tolerated. Azelastine provided effective prolong ed relief of the symptoms of perennial allergic rhinitis with no adver se effects that would limit its long-term use.