Effects of intranasal azelastine on the response to nasal allergen challenge.

OBJECTIVES/HYPOTHESIS: Azelastine, a second-generation H1-receptor antagonist, is available for topical administration. The aim of the study was to evaluate the effects of topical intranasal azelastine on the early-phase and the late-phase allergic responses and on nasal hyper-responsiveness to methacholine.

STUDY DESIGN

Double-blind, placebo-controlled, two-way crossover study in 20 subjects with seasonal allergic rhinitis, out of their allergy season.

METHODS

Subjects were randomly assigned to receive either placebo or two puffs of azelastine twice a day (548 microg/d) for 2 weeks followed by nasal challenge with allergen. Twenty-four hours later, while still receiving treatment, subjects underwent a nasal lavage and a nasal challenge with methacholine. End points included symptom scores, levels of mediators and number of eosinophils in nasal lavages, and the weight of secretions after methacholine challenge.

RESULTS

Compared with placebo, treatment with intranasal azelastine resulted in significant reductions in allergen-induced sneezing, rhinorrhea, itching, nasal congestion, and levels of albumin during the early-phase response (P <.05). Azelastine had no effect on levels of histamine or tryptase during the early-phase response. There was a significant eosinophil influx 24 hours after challenge, which was not inhibited by azelastine. Treatment with azelastine had no effect on the levels of albumin, interleukin-4, interleukin-5, intercellular adhesion molecule-1, tumor necrosis factor-alpha, and eosinophil cationic protein during the late-phase response. However, azelastine did show a significant inhibitory effect on the methacholine response 24 hours after nasal allergen challenge (P <.05).

CONCLUSIONS

The effects of intranasal azelastine are similar to those of oral second-generation antihistamines.