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.

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 PGD2 receptor 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).

Taxonomic position of clinical isolates of Candida famata.

We examined five clinical isolates formerly classified as Candida famata to clarify their taxonomic position by DNA-DNA reassociation studies and several phenotypic features. Four of the five isolates, M 5101, M 5102, M 5111 and M 5112, produced ascospores after being grown for 1 week on YM agar at 20 degrees C. By the API 20C system, three of the five isolates were identified as C. famata, and the other two strains as C. guilliermondii/C. famata. The antigenic patterns of all the isolates examined with the Candida Check kit were similar to those of C. guilliermondii. Specific antiserum against C. saitoana was obtained by adsorption. However, none of the clinical isolates tested reacted with this adsorbed serum. The mol% G + C of the four sporulated isolates ranged from 35.8 to 37.7 and that of the remaining, non-sporulated, isolate M 2054 was 43.4. The DNA reassociation value was determined by the spectrophotometric method. M 5111 and M 5112 were identified as Debaryomyces hansenii var. hansenii, M 5101 and M 5102 as D. hansenii var. fabryi and M 2054 as C. guilliermondii. The ascospore formation was exclusive to the four isolates related to D. hansenii. These findings suggest that with the exception of C. guilliermondii the other C. famata isolates examined all belong to a single species, D. hansenii.

[Effects of speaking tube in patients with dysacousis].

Comparative study was made between the conventional speaking tube and the modern electric hearing aid. The results revealed that the conventional speaking tube was inferior to the electric hearing aid in terms of specificity to various frequencies, advantages and understanding of singular syllables, but almost equal to the latter in terms of understandings of three syllables. Actual comparison by listening with both revealed a face that the speaking tube was more acceptable than the hearing aid in terms of naturalness of voice heard with it. It was assumed that the advantages of the speaking tube like this may be attributable to the less sense closure of eyes as it had an open end and consequently to the better hearing through the speaking tube, which may have made better understandable conversation.