title: A randomized controlled phase II clinical trial comparing ONO-4053, a novel DP1 antagonist, with a leukotriene receptor antagonist pranlukast in patients with seasonal allergic rhinitis.
abstract: BACKGROUND
  Prostaglandin D2(PGD2) 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 PGD2receptor 1 (DP1) 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 (T3NSS) as well as in individual scores for sneezing, rhinorrhea, and nasal itching. For T3NSS, 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 (JapicCTI-142706).
authors.affiliation: Department of Otorhinolaryngology, Nippon Medical School, Tokyo, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Okubo
authors.affiliation: Department of Otorhinolaryngology, Futaba Clinic, Tokyo, Japan.|Medical Corporation Shinanokai, Samoncho Clinic, Tokyo, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Hashiguchi
authors.affiliation: Department of Otorhinolaryngology, Takeda Clinic, Saitama, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Takeda
authors.affiliation: Department of Otorhinolaryngology, Takasaka Clinic, Saitama, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Baba
authors.affiliation: Department of Otorhinolaryngology, Kitagoh Clinic, Kanagawa, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Kitagoh
authors.affiliation: Department of Otorhinolaryngology, Miho Clinic, Kanagawa, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Miho
authors.affiliation: Department of Otorhinolaryngology, Tomomatsu Clinic, Tokyo, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Tomomatsu
authors.affiliation: Discovery Research Laboratories III, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Yamaguchi
authors.affiliation: Data Science, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Odani
authors.affiliation: Translational Science, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
authors.forename: H
authors.identifier: http://orcid.org/0000-0003-1960-9257
authors.initials: H
authors.lastname: Yamamotoya
mesh_terms: D000328:Adult; D015550:Cell Degranulation / Q000276:immunology; D002867:Chromones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008407:Mast Cells / Q000276:immunology / Q000378:metabolism; D008875:Middle Aged; D011982:Receptors, Prostaglandin / Q000037:antagonists & inhibitors*; D006255:Rhinitis, Allergic, Seasonal / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D012720:Severity of Illness Index; D063189:Symptom Assessment; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002867:Chromones; D020024:Leukotriene Antagonists; D011982:Receptors, Prostaglandin; C501562:prostanoid D receptor 1, human; C047681:pranlukast
keywords: Bayesian posterior probability; allergic rhinitis; leukotriene receptor antagonist; mast cell degranulation; prostaglandin D2 receptor 1 antagonist