Efficacy and Tolerability of Azelastine Nasal Spray in the Treatment of Allergic Rhinitis: Large Scale Experience in Community Practice

Summary

Two Spanish prospective monitoring studies evaluated efficacy and tolerability of azelastine nasal spray* containing azelastine hydrochloride for allergic rhinitis. Both studies were conducted by community practitioners over two weeks (Study I) or one month (Study II).

The numbers of patients recruited were 3680 (I) and 4002 (II). Of these, 56.1% (I) and 51.7% (II) had been previously treated with oral antihistamines with/without other medications. Patients rated the severity of 10 symptoms of allergic rhinitis as absent, mild. moderate or severe. Azelastine nasal spray was generally administered at a dose of one spray puff (0.14 mg) per nostril twice daily. Follow-up was after 14 days (I) or 31 days (II), when symptoms were rated and patients questioned about treatment.

Assessment was by a sum score for all 10 symptoms. A symptom sum score of 1620 occurred in 21.1% (I) and 13.7% (II) of patients before treatment and only 0.8% (I) and 0.6% (II) after treatment. A symptom sum score of 11—15 occurred in 35.9% (I) and 30.5% (II) of patients before treatment and only 2.6% (I) and 2.8% (II) after treatment. Overall, 92.3% (I) and 90.7% (II) of patients were completely pee of adverse events, 7.0% (I) and 8.8% (II) experienced one and 0.7% (I) and 0.6% (II) two adverse events. The number of doctors who rated efficacy as either very good or good was 89.4% (I) and 84.6% (II). General tolerance was rated as good or very good by 97.5% (I) and 97.3% (II), and local tolerance by 93.1% (I) and 91.5% (II) of physicians, respectively.

Overall, azelastine nasal spray was highly effective and very well tolerated in normal clinical practice.

Key Words::

• Allergic rhinitis
• Azelastine
• Topical treatment
• Post-marketing surveillance