Clinical Experience with Azelastine Nasal Spray in Children: Physician Survey of Case Reports

Abstract

Azelastine nasal spray, a topical second-generation antihistamine, was approved in the United States in 1996 for use in patients 12 years of age and older with seasonal allergic rhinitis. It was also recently approved for the treatment of seasonal allergic rhinitis in children 5–11 years of age. The efficacy and safety in children with allergic rhinitis has been demonstrated in 2 European double-blind, placebo-controlled, parallel-group trials. The objective of this study was to evaluate the clinical experience in the United States of a group of physicians treating patients <12 years of age with azelastine nasal spray. Three hundred physicians were sent a 1-page case report form which requested demographic characteristics, diagnosis of the rhinitis type, dosage and duration of therapy, assessment of symptom control, and any adverse drug reactions in these patients. Azelastine nasal spray was reported to be effective by the clinicians for the treatment of allergic rhinitis in children 5–11 years of age with comparable efficacy reported with dosages of one and two sprays per nostril twice daily. The adverse experience profile with azelastine nasal spray in children was similar to that in adults, with bitter taste (9.8%) and dysesthesia/nasal burning (1.9%) the most commonly reported adverse experiences. At the recommended dosage (one spray per nostril twice daily), azelastine was report to be a useful addition to the currently available therapies for allergic rhinitis in children.