Late phase II study of R50547 (Levocabastine Hydrochloride) nasal spray in perennial allergic rhinitis

Abstract

In order to determine the optimal dose regimen of R 50547 nasal spray in the treatment of perennial allergic rhinitis, a single-blind comparative study was carried out in total 153 patients on 0.025% b. i. d.(LB group, 0.2mg/day), 0.025% q. i. d.(LQ group, 0.4mg/day) and 0.05% b. i. d.(HB group, 0.4 mg/day) dosages each administered for 4 weeks. In the final global improvement rating, a rating of “moderately improved” or better was obtained in 49% of the patients in LB group, 56% in LQ group and 48% in HB group. The differences among the groups were not statistically significant. In the overall safety rating, cases assessed as “no problem” exceeded 96%, with a low incidence of adverse reactions of 4% in each group. The global utility rating showed the results similar to the with the final global improvement rating, with no statistically significant differences among the three dosage groups. Based on the above results, 0.025% q. i. d. seems to be the optimal dose regimen of R 50547 nasal spray in the treatment of perennial allergic rhinitis.