Double-blind, placebo-controlled trial of the efficacy and safety of azelastine hydrochloride in children with perennial allergic rhinitis.

Background: Allergic rhinitis (AR) affects up to 40% of the pediatric population. The US practice parameter recommends the use of INAH or INCS as first-line therapy for the treatment of AR. Although not directly targeted to children, the recent US Practice Parameters proposed intranasal antihistamines 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 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 = .005) and 0.10% AZE (P = .015) vs. placebo. 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. 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 one patient in the 0.1% group and one placebo patient (both of mild severity and unlikely to be related to treatment). None of the patients reported fatigue.

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