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Background  Prostaglandin D 2  ( PGD  2 ) is primarily produced by mast cells and is contributing to the nasal symptoms including nasal obstruction and rhinorrhea.    Objective  This study aimed to evaluate the efficacy and safety of a novel  PGD  2  receptor 1 ( DP 1) antagonist,  ONO ‐4053, in patients with seasonal allergic rhinitis ( SAR ).    Methods  This study was a multicenter, randomized, double‐blind, parallel‐group study of patients with  SAR . Following a one‐week period of placebo run‐in, patients who met the study criteria were randomized to either the  ONO ‐4053, leukotriene receptor antagonist pranlukast, or placebo group for a two‐week treatment period. A total of 200 patients were planned to be randomly assigned to receive  ONO ‐4053, pranlukast, or placebo in a 2:2:1 ratio. Nasal and eye symptoms were evaluated.    Results  Both  ONO ‐4053 and pranlukast had higher efficacy than placebo on all nasal and eye symptoms.  ONO ‐4053 outperformed pranlukast in a total of three nasal symptom scores (T3 NSS ) as well as in individual scores for sneezing, rhinorrhea, and nasal itching. For T3 NSS , the Bayesian posterior probabilities that pranlukast was better than placebo and  ONO ‐4053 was better than pranlukast were 70.0% and 81.6%, respectively, suggesting that  ONO ‐4053 has a higher efficacy compared with pranlukast. There was no safety‐related issue in this study.    Conclusions  We demonstrated that the efficacy of  ONO ‐4053 was greater than that of pranlukast with a similar safety profile. This study indicates the potential of  ONO ‐4053 for use as a treatment for  SAR  (Japic CTI ‐142706).

allergy

A randomized controlled phase  II  clinical trial comparing  ONO ‐4053, a novel  DP 1 antagonist, with a leukotriene receptor antagonist pranlukast in patients with seasonal allergic rhinitis