Effectiveness of Azelastine Nasal Solution in Seasonal Allergic Rhinitis

Abstract

Azelastine is a novel antiallergy medication currently under investigation for the treatment of allergic rhinitis and asthma. Pharmacologic studies in laboratory animals and in vitro model systems indicate that azelastine exerts multiple actions including modulation of airways smooth muscle response, interference with inflammatory processes, and inhibition of allergic reactions. In a previous controlled clinical trial, azelastine nasal solution (ASTELIN N.S.™) demonstrated effectiveness in controlling symptoms of seasonal allergic rhinitis (SAR). The objective of this 2-week double-blind, parallel-group study was to further assess the effectiveness of azelastine nasal solution in improving allergic rhinitis symptoms. Two hundred forty-seven patients (≥12 years) with symptomatic SAR who satisfied a minimum symptoms score during a 1-week, single-blind, baseline evaluation period were randomized to receive azelastine 2 sprays per nostril bid, azelastine 2 sprays per nostril qd, chlorpheniramine 12 mg bid, or placebo using a double-dummy technique to insure blinding. The primary efficacy variables were changes in Major Symptom Complex (nose blows, sneezes, runny nose/sniffles, itch nose, and watery eyes) and Total Symptom Complex (Major plus itchy eyes/ears/throat/palate, cough, and postnasal drip) severity scores. Patients treated with azelastine nasal solution qd and bid had mean percent improvements in the Total and Major Symptom Complex severity scores that were clinically significant (≥50% improvement over placebo) after both weeks, at endpoint, and overall. The improvements for the azelastine bid group were statistically significant (P≤.05) at all evaluation points. Adverse experiences occurred infrequently, and none was considered serious or potentially limiting to the clinical utility of the nasal solution. The favorable safety profile of azelastine nasal solution together with its rapid onset and prolonged duration of action in relieving rhinitis symptoms and advantages over currently marketed topical treatments make it a good choice for treatment of SAR. The results of this trial demonstrate that azelastine nasal solution provides an alternative to oral medication in the treatment of SAR.

Comparative Efficacy and Safety of Azelastine and Levocabastine Nasal Sprays in Patients with Seasonal Allergic Rhinitis

“…The significance ot the reported results might have been even increased by incorporating a placebo-group in the study design; however, we felt such a procedure inappropriate and unethical towards our patients, particularly since in a couple of earlier studies azelastine showed superiority over placebo [16][17][18][19]26].…”

Rhinitis 2020: A practice parameter update

“…[326][327][328][329][330][331][332]338 They have been shown to improve nasal as well as nonnasal AR symptoms and QOL. 330,331,342 Azelastine has also been shown to be clinically effective in controlling symptoms of NAR. 343 Although olopatadine has been demonstrated to significantly reduce nasal symptoms induced by a hyperosmolar mannitol challenge in patients with vasomotor NAR, there are no placebo-controlled trials to support its efficacy in relief of NAR symptoms.…”

Meta‐Analysis of Azelastine Nasal Spray for the Treatment of Allergic Rhinitis

“…Patients as young as 12 years were included, and three of the studies were double blind. Two studies lasted 2 days, 26,27 two lasted 2 weeks, 23,25 and one lasted 4 weeks. 18 Point estimates for the risk difference were positive in the five comparisons of azelastine nasal spray with placebo and ranged from 0.05 (95% confidence interval [CI] -0.08-0.17) to 0.33 (95% CI 0.16-0.50).…”

“…Nine studies were included in the meta- analysis of effect size. Seven included patients with seasonal allergic rhinitis, 9,18,19,20,23,25,26 and two included patients with nonallergic vasomotor rhinitis. 7 All of the studies were conducted in the United States, all included patients 12 years of age or older, and all involved azelastine nasal spray 1.12 mg/day.…”

“…Six were double blind, but blinding status for three was unknown. Two studies were 1 week or shorter, 20,26 four studies were 2 weeks, 9,19,23,25 and three were 3 weeks or longer. 7,18 The point estimate for the effect size was positive in all of the studies in which azelastine nasal spray was compared with placebo.…”