Clinical Evaluation of Azelastine Nasal Spray versus Terfenadine in the Treatment of Allergic Rhinitis

BACKGROUND: Anitihistamines are primarile used for the therapy of allergic rhinitis. Azelastine tablet is very effective and well tolerated. The newly developed Azelastine nasal spray has the advantage of acting more rapidly and in lower doses because of the local administration in the affected area. METHODS: This study was designed as double-blind, randomized, active controlled with parallel group to compare the therapeutic efficacy and tolerance of intranasal Azelastine with that of Terfenadine tablet in relieving both the nasal and eye symptoms in allergic rhinitis patients. RESULTS: The results showed that after 2 weeks of treatment, 79% of patients in Azelastine group (n=19) and 59% of patients in Terfenadine group (n=23) had improvement in the symptom assessment. The percentage was not statistically different between treatments (p＞0.20). Except for the event of bitter taste when significant difference was found in Azelastine group, other adverse experiences were compatible between treatments. CONCLUSIONS: This clinical study demonstrates the efficacy and safety of a twice daily dosage of Azelastine nasal spray, 0.14 mg per nostril (0.56mg Azelastine/day), in the treatment of allergic rhinitis. The efficacy of Azelastine nasal spray is at least as good as that of Terfenadine, 60 mg tablets b.i.d. The safety outcomes show that Azelastine nasal spray is safe in the treatment of allergic rhinitis. (J Taiwan Otolaryngol Head Neck Surg 1999;34:471-478)