A Double-Blind Non-inferiority Clinical Study of Montelukast, a Cysteinyl Leukotriene Receptor 1 Antagonist, Compared with Pranlukast in Patients with Seasonal Allergic Rhinitis

During the course of development of montelukast, a cysteinyl leukotriene receptor 1 antagonist, for treatment of seasonal allergic rhinitis, a double-blind, non-inferiority study was carried out to evaluate the efficacy and safety of montelukast 5 mg and 10 mg compared with pranlukast 450 mg, which has a similar mechanism of action. Montelukast 5 mg, 10 mg or pranlukast 450 mg and the corresponding placebo were orally administered to patients with seasonal allergic rhinitis three times a day for 2 weeks. Non-inferior efficacy of montelukast 5 mg and 10 mg to pranlukast 450 mg was investigated by the change from the baseline in the composite nasal symptoms scores over the 2-week treatment period. Montelukast 5 mg, 10 mg once daily and the pranlukast 450 mg/day showed significant improvements in the change from the baseline in the composite, daytime and nighttime nasal symptom scores, and the improvement lasted for 2 weeks. Montelukast 5 mg and 10 mg were non-inferior to pranlukast 450 mg in the change from the baseline in the composite nasal symptoms scores. The incidence rates of adverse experiences and drug-related adverse experiences were not significantly different among the three treatment groups. The results indicate that administration of montelukast 5 mg and 10 mg once daily are potent alternatives for the treatment of seasonal allergic rhinitis and demonstrated that the efficacy and the safety profiles are comparable with pranlukast 450 mg/day.