ONSET OF ACTION OF AZELASTINE HCL NASAL SPRAY 0.15% EVALUATED IN AN ENVIRONMENTAL EXPOSURE CHAMBER

Abstract

<h3>Introduction</h3> Azelastine nasal spray is an effective treatment in managing seasonal allergic rhinitis (SAR). The objective of this single center, double-blinded, placebo-controlled study was to evaluate the time to onset of efficacy of azelastine HCl 0.15% in the relief of nasal symptoms of SAR in an environmental exposure chamber (EEC). <h3>Methods</h3> 110 participants aged 18 to 65 years were randomized to receive azelastine HCl 0.15% or placebo nasal spray after being continuously exposed to ragweed pollen in an EEC. The primary efficacy parameter was the time to onset of efficacy of azelastine as measured by the change from baseline in total nasal symptom score (TNSS) versus placebo. <h3>Results</h3> Azelastine HCl 0.15% demonstrated a statistically significant improvement in TNSS compared with placebo starting from 30 minutes post-dose (p=0.0002), and the effect was sustainable at all time points throughout the end of the EEC session at 240 minutes post dose (p= <0.0001). Adverse events observed was consistent with known safety profile. No serious adverse events or other significant AEs were reported. <h3>Conclusions</h3> This is the first study assessing the onset of action of azelastine HCl 0.15% in an EEC, demonstrating a fast onset in 30 minutes. Azelastine HCl 0.15% nasal spray was well tolerated and there were no safety concerns raised during this SAR study. The rapid onset of action for the relief of allergy symptoms combined with a safe side effect profile indicate azelastine HCl 0.15% is a valuable treatment option for allergic rhinitis.