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

BACKGROUND: 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 5mg and 10mg compared with pranlukast 450mg, which has a similar mechanism of action. METHODS: Montelukast 5mg, 10mg or pranlukast 450mg 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 5mg and 10mg to pranlukast 450mg was investigated by the change from the baseline in the composite nasal symptoms scores over the 2-week treatment period. RESULTS: Montelukast 5mg, 10mg once daily and the pranlukast 450mg/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 5mg and 10mg were non-inferior to pranlukast 450mg 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. CONCLUSIONS: The results indicate that administration of montelukast 5mg and 10mg 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 450mg/day.