BackgroundProstaglandin D2 (PGD
2) is primarily produced by mast cells and is contributing to the nasal symptoms including nasal obstruction and rhinorrhea.ObjectiveThis study aimed to evaluate the efficacy and safety of a novel PGD
2 receptor 1 (DP1) antagonist, ONO‐4053, in patients with seasonal allergic rhinitis (SAR).MethodsThis 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.ResultsBoth 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.ConclusionsWe 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).
We studied the prophylactic and therapeutic effect of ketotifen in patients with Japanese cedar pollinosis.We administratered ketotifen orally to patients before the beginning of the dispersion of pollen.Ketotifen aqueous nasal spray (ketotifen-ANS) was administered to the poor-response groups in the prophylactic and therapeutic group.In the assessment of the final overall prophylactic effect 48.8% of the patients examined during the season showed "marked" or "moderate" effectiveness.The poor-response patients treated with ketotifen-ANS showed marked or moderate effectiveness in 83.2%. The therapeutic results were good in 59.3% of those treated after symptoms had started. Ketotifen-ANS was useful in both the poor-response and the therapeutic groups.The only side effect was sleepiness 7 patients receiving oral ketotifen. No abnormality was observed in those treated with ketotifen-ANS.Oral ketotifen and aqueous nasal spray ketotifen are considered to be excellent for the prophylaxis and therapy of Japanese cedar pollinosis.
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