Premium
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
Author(s) -
Okubo K.,
Hashiguchi K.,
Takeda T.,
Baba K.,
Kitagoh H.,
Miho H.,
Tomomatsu H.,
Yamaguchi S.,
Odani M.,
Yamamotoya H.
Publication year - 2017
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/all.13174
Subject(s) - medicine , placebo , rhinorrhea , surgery , pathology , alternative medicine
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).