A four-way, double-blind, randomized, placebo controlled study to determine the efficacy and speed of azelastine nasal spray, versus loratadine, and cetirizine in adult subjects with allergen-induced seasonal allergic rhinitis

Abstract

BackgroundAzelastine has been shown to be effective against seasonal allergic rhinitis (SAR). The Environmental Exposure Unit (EEU) is a validated model of experimental SAR. The objective of this double-blind, four-way crossover study was to evaluate the onset of action of azelastine nasal spray, versus the oral antihistamines loratadine 10 mg and cetirizine 10 mg in the relief of the symptoms of SAR.Methods70 participants, aged 18-65, were randomized to receive azelastine nasal spray, cetirizine, loratadine, or placebo after controlled ragweed pollen exposure in the EEU. Symptoms were evaluated using the total nasal symptom score (TNSS). The primary efficacy parameter was the onset of action as measured by the change from baseline in TNSS.ResultsAzelastine displayed a statistically significant improvement in TNSS compared with placebo at all time points from 15 minutes through 6 hours post dose. Azelastine, cetirizine, and loratadine reduced TNSS compared to placebo with an onset of action of 15 (p < 0.001), 60 (p = 0.015), and 75 (p = 0.034) minutes, respectively. The overall assessment of efficacy was rated as good or very good by 46% of the participants for azelastine, 51% of the participants for cetirizine, and 30% of the participants for loratadine compared to 18% of the participants for placebo.ConclusionsAzelastine’s onset of action for symptom relief was faster than that of cetirizine and loratadine. The overall participant satisfaction in treatment with azelastine is comparable to cetirizine and statistically superior to loratadine. These results suggest that azelastine may be preferential to oral antihistamines for the rapid relief of SAR symptoms.

Clinical Validation of Controlled Grass Pollen Challenge in the Environmental Exposure Unit (EEU)

“…The EEU has proven effective in multiple studies evaluating various aspects of seasonal allergic rhinitis and its treatments [4][5][6][7][8][9][10][11][12][13][14][15][16][17]. Previous studies conducted in the EEU using ragweed pollen have shown 3500 grains/m 3 ± 500 to be an optimal concentration to produce symptoms similar to those experienced in the outdoor environment.…”

Controlled Allergen Challenge Facilities and Their Unique Contributions to Allergic Rhinitis Research

“…Recently, the EEU was used to examine azelastine nasal spray vs. orally administered cetirizine, loratadine, or placebo [57]. Azelastine nasal spray significantly reduced nasal symptoms, compared with placebo, and exhibited a faster onset of action compared to oral treatments [57].…”

Evaluation of nasal fluid β-defensin 2 levels in children with allergic rhinitis

“…The patient or family was asked to score between 0 and 3 for each of four main symptoms of AR (nasal obstruction, sneezing, discharge, pruritus) (Table 1). Thus, TSS scores ranged between 0 and 12 (14).…”