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Using 0.15% azelastine hydrochloride (one spray per nostril, twice daily) effectively improves perennial allergic rhinitis symptoms in children, with excellent safety and tolerability.
A randomized, double-blind, 28-day clinical trial portrayed that azelastine hydrochloride (AZE) nasal spray is a safe and effective intervention for perennial allergic rhinitis (PAR) in school-age children (6–11 years). While US practice guidelines endorse intranasal antihistamines for allergic rhinitis, studies in children with persistent symptoms have been scarce—until now. Hence, this study sought to investigate AZE for pediatric PAR management.
The study included 486 children with moderate-to-severe PAR, comparing AZE 0.10% and AZE 0.15% to a placebo (one spray per nostril, twice daily). Researchers measured changes in reflective total nasal symptom score (rTNSS) from baseline. The results were compelling. AZE 0.15% markedly reduced rTNSS when compared to placebo, with a least square mean change of −3.45 (20.2%), while AZE 0.10% also showed meaningful improvement with a least square mean change of −3.37 (20.5%).
Importantly, both doses were well-tolerated, with only 1 mild case of somnolence in the 0.10% group and no reports of fatigue. To sum up, the higher dose (0.15%) of AZE prominently improved symptoms of PAR in school-age children, demonstrating both efficacy and good tolerance over a 28-day period.
International Archives of Allergy and Immunology
Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Azelastine Hydrochloride in Children with Perennial Allergic Rhinitis
Jean Bousquet et al.
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