Clinical investigation of R 50547 (Levocabastine hydrochloride) nasal spray in perennial allergic rhinitis

phase III comparative trial with Sodium Cromoglicate

Abstract

The efficacy and safety of a 0.025% R50547 nasal spray q. i. d.(L group) were assessed in 233 patients with perennial allergic rhinitis, by a single-blind comparative study using a 2% sodium cromoglicate nasal spray six times daily (S group). In the final global improvement rating, L group showed significantly higher improvement than S group (U test: p<0.05). The rates of “moderately improved” or better were 60.2% in L group and 45.4% in S group, with a 15% difference being demonstrated. In the overall safety rating, there was no statistic difference between the two administration groups. With regard to the global utility rating, based on the results of final global improvement rating and overall safety rating, L group demonstrated a significantly higher usefulness rate than S group (U test: p<0.05). Based on the above results, it is concluded that R50547 provides superior clinical efficacy to sodium cromoglicate, while it shows the same high level of safety in the treatment of perennial allergic rhinitis