Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Azelastine Hydrochloride in Children with Perennial Allergic Rhinitis.

Introduction: Allergic rhinitis (AR) affects up to 40% of the pediatric population. The US practice parameter recommends the use of intranasal antihistamines (INAH) or INCS as first-line therapy for the treatment of AR. Although not directly targeted to children, the recent US practice parameters proposed INAH as first-line therapy whereas the ARIA guidelines did not.

Methods: This was a randomized, double-blind, parallel-group study with a duration of 28 days. It compared azelastine hydrochloride (AZE) 0.10% and 0.15% to placebo of one spray per nostril twice daily in pediatric subjects with moderate-to-severe symptomatic perennial allergic rhinitis (PAR).

Results: A total of 486 subjects were included in the study. The change from baseline rTNSS was statistically significant for 0.15% AZE (p = 0.005) and 0.10% AZE (p = 0.015) versus placebo. Here, 0.15% AZE showed an LS mean change of -3.45 (20.2%) over the 28-day treatment period from a baseline value of 16.60 in rTNSS, and 0.10% AZE showed an LS mean change of -3.37 (20.5%) over the 28-day treatment period from a baseline value of 16.35 in rTNSS. Somnolence was reported by 1 patient in the 0.1% group and 1 placebo patient (both of mild severity and unlikely to be related to treatment). None of the patients reported fatigue.

Conclusions: Here, 0.15% AZE significantly improved the overall rTNSS compared with placebo over the 28-day study period. A 0.15% AZE was well tolerated in this study.

Key Messages: It is essential to perform studies in school children (6-11 years). However, for INAH, few studies exist in SAR, and, to our knowledge, there are no studies in PAR. This study shows for the first time that the higher dose of AZE is safe and effective in school children with PAR.