LEVOCABASTINE NASAL SPRAY BETTER THAN SODIUM CROMOGLYCATE AND PLACEBO IN THE TOPICAL TREATMENT OF SEASONAL ALLERGIC RHINITIS

The efficacy and safety of the nasal administration (twice in each nostril, four times a day) of levocabastine (0.5 mg/ml) were compared with those of sodium cromoglycate (20 mg/ml) and placebo in a 2-week, parallel, double-blind trial in patients with seasonal allergic rhinitis. At the end of treatment, 89% of patients in the levocabastine-treated group rated their treatment as globally good or excellent as compared with 32% (p = 0.003) of sodium cromoglycate-treated and 35% (p = 0.002) of placebo-treated patients. According to the investigators' ratings, the severest nasal symptom and ocular complaints responded better to levocabastine than to cromoglycate (p = 0.05 and p = 0.03) or placebo treatment (p = 0.001). Visual analogue scale ratings in patients' diaries indicated that at the end of therapy, nasal symptoms were less severe in the levocabastine-treated group than in the sodium cromoglycate-treated (p = 0.03) or placebo-treated group (p = 0.001). Total symptom severity as a percentage of the theoretical maximum symptom severity during the treatment period was lower for levocabastine than for sodium cromoglycate (p = 0.06) or placebo (p = 0.004) for the severest nasal symptom (35% versus 47% and 76%), sneezing (the most frequent symptom) (27% versus 42% and 67%), and itchy nose (18% versus 37% and 67%). The percentage of days at which nasal symptoms were entirely absent was markedly higher in the levocabastine-treated (33%) than in the sodium cromoglycate-treated (9%; p = 0.006) or placebo-treated (3%; p = 0.001) group. Adverse effects in the levocabastine-treated and sodium cromoglycate-treated group, and, in particular, daytime fatigue, did not occur more frequently than with placebo treatment. It is concluded that levocabastine is an efficacious and well-tolerated drug in the treatment of seasonal allergic rhinitis.