Intranasal levocabastine for the treatment of seasonal allergic rhinitis: a multicentre, double-blind, placebo-controlled trial.

In this international, multicentre, randomized, double-blind, parallel-group, placebo-controlled trial 262 patients participated to assess the efficacy and tolerability of levocabastine nasal spray in the treatment of seasonal allergic rhinitis. Patients were randomized to receive either twice daily 0.05% levocabastine or matching placebo nasal spray with a treatment duration of four weeks. Assessments of global therapeutic efficacy favoured levocabastine. At the end of the trial, 55% of levocabastine-treated patients considered therapeutic efficacy to be excellent or good compared to 36% of those who received placebo (p < 0.001). The corresponding values for the investigator assessments were 54% and 37% (p < 0.001), respectively. Analysis of patients' diary data showed significantly lower AUCs for all parameters in the levocabastine group (p < 0.05). Investigator assessments revealed a trend towards a greater reduction in individual symptom severity from baseline in levocabastine-treated patients compared to placebo-treated controls. Adverse experiences were reported by 21% of levocabastine-treated patients and by 19% of those who received placebo, with no statistically significant differences in incidence or type. Headache and local reactions following application were the most frequently reported adverse events. Levocabastine nasal spray appears to be effective and well-tolerated for the treatment of seasonal allergic rhinitis and is an alternative to oral antihistamines.