TOPICAL LEVOCABASTINE COMPARED WITH ORALLY-ADMINISTERED TERFENADINE FOR THE PROPHYLAXIS AND TREATMENT OF SEASONAL RHINOCONJUNCTIVITIS

Background: This study was designed to compare the efficacy and tolera bility of a new topical (nasal spray and eye drops) H-1-receptor antag onist, levocabastine, with that of orally administered terfenadine for the prophylaxis and treatment of seasonal allergic rhinoconjunctiviti s. Methods: A total of 115 patients with documented birch pollen aller gy were enrolled in this randomized, double-blind, double-dummy, paral lel-group trial. Treatment was initiated immediately before the birch pollen season started and continued for a total of 8 weeks. Xylometraz oline (Otrivin) nasal spray was permitted as rescue medication. Result s: The investigator's evaluation of symptoms showed similar effects fo r levocabastine and terfenadine. Both the patients' and the investigat or's global evaluations of ocular and nasal symptoms disclosed a somew hat higher percentage of good or excellent results for levocabastine, but the differences were not statistically significant. Visual analog scale ratings from the patients' diaries showed better results for lev ocabastine. Levocabastine was significantly more effective than terfen adine in relieving sneezing, rhinorrhea, lacrimation, itch, and burnin g sensation (p < 0.05). For some symptoms, levocabastine was significa ntly more effective than terfenadine on days when the pollen count was high. There were no statistically significant differences in the use of rescue medication or in the incidence of adverse reactions reported in each treatment group. Conclusions: In the present study topical le vocabastine was frequently more effective than orally administered ter fenadine for the treatment of seasonal allergic rhinoconjunctivitis. B oth drugs were well-tolerated.