Clinical study of leukotriene antagonist ONO-1078 (pranlukast hydrate), on perennial allergic rhinitis

A double-blind, dose finding study ( late phase II study)

Abstract

A multi-institution double-blind group-comparison study of ONO-1078 (pranlukast hydrate) was performed at 3 doses to evaluate its efficacy, safety, and optimal dose in patients with perennial nasal allergy. A total of 198 subjects were enrolled, and pranlukast was administered at 75mg/day to 66 subjects (group L), at 225mg/day to 68 subjects (group M), and at 450 mg/day to 64 subjects (group H). The final global improvement rate was 44.8% in group L, 46.7% in group M, and 64.3% in group H. The rate was dose-dependent and was significantly higher in group H than in group L. According to the nasal allergy diary, the three principal symptoms, namely sneezing, nasal secretion, and nasal congestion, progressively and significantly decreased in all three groups, while the decreases in nasal secretion and nasal congestion were significantly greater in group H than in group L. The overall safety rating was “safe” in 93.8% in group L, 86.6% in group M, and 88.5% in group H, and adverse experiences were observed in 4.6% of group L, 13.4% of group M, and 11.5% in group H, wih no significant difference observed in the three groups. The usefulness rate was 44.1% in group L, 45.9% in group M, and 59.6% in group H, and these findings were also dose-dependent.