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.
Highlights
Seasonal allergic rhinitis (SAR) is an inflammatory disease characterized by multiple symptoms including sneezing, rhinnorhea, nasal congestion, nasal and nasopharyngeal itching, and has associated ocular symptoms such as itchy, watery and red/burning eyes [1]
The primary efficacy parameter was the onset of action measured by the change from baseline in total nasal symptom score (TNSS)
Azelastine showed a statistically significant improvement in the TNSS at 15 minutes compared with placebo (p < 0.001), and the effect was durable at each time point during the 6 hours post-dose (p < 0.001)
Summary
Seasonal allergic rhinitis (SAR) is an inflammatory disease characterized by multiple symptoms including sneezing, rhinnorhea, nasal congestion, nasal and nasopharyngeal itching, and has associated ocular symptoms such as itchy, watery and red/burning eyes [1]. With the ability to control these variables, study conditions can be reproduced on different days at any time of the year with the same or different study participants, something that cannot be achieved with any other research model for allergic rhinitis. Utilizing this model yields more precise results for direct comparisons of different treatment modalities [14]. 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
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