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Volume 41, Issue 2Supplement1
Displaying 1-8 of 8 articles from this issue
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single administration studyMinoru OKUDA, Shunichi TOMIYAMA, Shunkichi BABA, Masaki OHNISHI, Shink ...1995 Volume 41 Issue 2Supplement1 Pages 281-300
Published: March 20, 1995
Released on J-STAGE: May 10, 2013
JOURNAL FREE ACCESSThe safety, pharmacokinetics and inhibitory effect on histamine-induced nasal reaction of R 50547 nasal spray were assessed in healthy male volunteers. As subjective symptoms, slight nasal irritation, nasal itching, increased nasal discharge, nasal obstruction, parosmia and sneezing were observed. Moreover, although the laboratory test values such as while blood cell count changed significantly after the administration (p<0.05), no abnormal changes caused by the drug were observed. In the pharmacokinetic analysis, almost the same results were obtained in the Tmax and t1/2 after single administrations of 0.1 mg and 0.2mg, and the dose-dependence were observed in the Cmax and AUC values. Concerning the inhibitory effect on histamine-induced nasal reaction, the reaction threshold of allergic rhinitis significantly (p<0.05) elevated until 8 hours after administration of 0.2mg. Based on the above results, R 50547 nasal spray demonstrated good tolerance and long-lasting inhibitory effect on symptoms of allergic rhinitis induced by histamine.View full abstractDownload PDF (28776K) -
repeated administration studyMinoru OKUDA, Shunichi TOMIYAMA, Masaki OHNISHI, Shinichi TAIRA, Shink ...1995 Volume 41 Issue 2Supplement1 Pages 301-325
Published: March 20, 1995
Released on J-STAGE: May 10, 2013
JOURNAL FREE ACCESSThe safety and pharmacokinetics of R50547 nasal spray were assessed by repeated consecutive administration to healthy male volunteers for 11 days or 28 days. There were no abnormalities in terms of the nasal mucosal findings, paranasal X-ray findings, general examination or nasal mucociliary clearance. No adverse reactions were observed in the 11-day treatment, but transient sleepiness was observed in the 28-day treatment. Also, there were some statistically significant changes in laboratory test values such as total protein in the 11-day treatment. However, it was concluded that they did not represent clinical problems as the result of the 28-day treatment. In the pharmacokinetic analysis of the 11-day treatment, no accumulation due to the treatment with R50547 was observed. Based on the above results, the safety of R50547 nasal spray in repeated administration was confirmed.View full abstractDownload PDF (33669K) -
nasal provocation testMinoru OKUDA, Shunichi TOMIYAMA, Masaki OHNISHI, Shinichi TAIRA, Kouic ...1995 Volume 41 Issue 2Supplement1 Pages 326-341
Published: March 20, 1995
Released on J-STAGE: May 10, 2013
JOURNAL FREE ACCESSThe pharmacokinetics and inhibitory effect on nasal provocation test (NPT) of R 50547 nasal spray were assessed in 12 volunteers with allergic rhinitis. In the pharmacokinetic analysis, the t,, and Tmax in the 0.1mg and 0.2mg were almost similar to the results of the single administration study in healthy volunteers. Based on the results for the inhibitory effect on NPT, the effect lasted for 8 hours, 8 hours and 12 hours in 0.05mg group, 0.1mg group and 0.2mg group, respectively. From these lasting time, the optimal dosing frequency was surmised to be two or three times daily for the 0.05mg and 0.1mg doses and two times daily for the 0.2mg dose. The above results thus demonstrate the inhibitory effect of the R 50547 nasal spray on NPT and indicate that this drug is useful in the treatment of allergic rhinitis showing a long-lasting effect while requiring only several administrations per day.View full abstractDownload PDF (22805K) -
Minoru OKUDA, Minoru TORIYAMA, Atsushi USAMI, Toru SEKITANI, Goro MOGI ...1995 Volume 41 Issue 2Supplement1 Pages 342-360
Published: March 20, 1995
Released on J-STAGE: May 10, 2013
JOURNAL FREE ACCESSThe clinical efficacy and safety of R 50547 nasal spray were assessed by a double-blind comparative study in 121 patients with perennial allergic rhinitis to determine the optimal dose. Patients were divided into three groups using a 0.0125% (L group), 0.025% (M group) or 0.05% (H group) R 50547 nasal spray, twice daily for one week. In the efficacy analysis, cases assessed as “moderately improved” or better accounted for 36% in L group, 41% in M group and 38% in H group. There were no significant intergroup differences or dose-dependence. In the safety analysis, only pharygeal discomfort, sore throat and sneezing as local symptoms and mild sleepiness as a systemic symptom were observed. High safety was shown, without any significant intergroup differences. Based on the above results, the efficacy and safety of R 50547 nasal spray in the treatment of perennial allergic rhinitis were comfirmed. With regard to the optimal dosage, further clinical study is needed since the improvement rate showed no dose-dependence.View full abstractDownload PDF (26973K) -
Minoru OKUDA, Minoru TORIYAMA, Atsushi USAMI, Toru SEKITANI, Goro MOGI ...1995 Volume 41 Issue 2Supplement1 Pages 361-380
Published: March 20, 1995
Released on J-STAGE: May 10, 2013
JOURNAL FREE ACCESSIn order to determine the optimal dose regimen of R 50547 nasal spray in the treatment of perennial allergic rhinitis, a single-blind comparative study was carried out in total 153 patients on 0.025% b. i. d.(LB group, 0.2mg/day), 0.025% q. i. d.(LQ group, 0.4mg/day) and 0.05% b. i. d.(HB group, 0.4 mg/day) dosages each administered for 4 weeks. In the final global improvement rating, a rating of “moderately improved” or better was obtained in 49% of the patients in LB group, 56% in LQ group and 48% in HB group. The differences among the groups were not statistically significant. In the overall safety rating, cases assessed as “no problem” exceeded 96%, with a low incidence of adverse reactions of 4% in each group. The global utility rating showed the results similar to the with the final global improvement rating, with no statistically significant differences among the three dosage groups. Based on the above results, 0.025% q. i. d. seems to be the optimal dose regimen of R 50547 nasal spray in the treatment of perennial allergic rhinitis.View full abstractDownload PDF (29095K) -
phase III comparative trial with Sodium CromoglicateMinoru OKUDA, Minoru TORIYAMA, Atsushi USAMI, Toru SEKITANI, Goro MOGI ...1995 Volume 41 Issue 2Supplement1 Pages 381-403
Published: March 20, 1995
Released on J-STAGE: May 10, 2013
JOURNAL FREE ACCESSThe efficacy and safety of a 0.025% R50547 nasal spray q. i. d.(L group) were assessed in 233 patients with perennial allergic rhinitis, by a single-blind comparative study using a 2% sodium cromoglicate nasal spray six times daily (S group). In the final global improvement rating, L group showed significantly higher improvement than S group (U test: p<0.05). The rates of “moderately improved” or better were 60.2% in L group and 45.4% in S group, with a 15% difference being demonstrated. In the overall safety rating, there was no statistic difference between the two administration groups. With regard to the global utility rating, based on the results of final global improvement rating and overall safety rating, L group demonstrated a significantly higher usefulness rate than S group (U test: p<0.05). Based on the above results, it is concluded that R50547 provides superior clinical efficacy to sodium cromoglicate, while it shows the same high level of safety in the treatment of perennial allergic rhinitisView full abstractDownload PDF (36623K) -
long-term administration studyMinoru OKUDA, Minoru TORIYAMA, Atsushi USAMI, Toru SEKITANI, Goro MOGI ...1995 Volume 41 Issue 2Supplement1 Pages 404-416
Published: March 20, 1995
Released on J-STAGE: May 10, 2013
JOURNAL FREE ACCESSThe efficacy and safety of R50547 nasal spray were assessed in 42 patients with perennial allergic rhinitis after long-term administration for at least 8 weeks and at most 13 weeks. In the final global improvement rating, 56% of the total cases showed “moderately improved” or better while the improvement rate was 62% in patients treated over 4 weeks. The clinical efficacy thus did not decrease during the long-term administration. As adverse reactions, sleepiness and headache were observed, but they were not severe. Moreover, no new adverse reactions manifested as a result of the long-term administration of the drug. Based on the above results, the efficacy and safety of R50547 nasal spray were confirmed in the long-term treatment of perennial allergic rhinitis.View full abstractDownload PDF (20582K) -
Minoru OKUDA, Minoru TORIYAMA, Atsushi USAMI, Toru SEKITANI, Goro MOGI ...1995 Volume 41 Issue 2Supplement1 Pages 417-431
Published: March 20, 1995
Released on J-STAGE: May 10, 2013
JOURNAL FREE ACCESSThe efficacy and safety of R 50547 nasal spray were assessed in 60 pediatric patients with perennial allergic rhinitis in accordance with the dose regimen for adults (0.025% q. i. d.). In the final global improvement rating, 50% showed “moderately improved” or better. The improvement rating of each nasal symptom was 59% in sneezing, 57% in rhinorrhea, and 66% in obstruction respectively. The highest improvement rating was observed in obstruction among the three major symptoms, and this good efficacy was considered to be one of the clinical characteristics of the drug. Adverse reactions were seen in only two cases, consisting of nasal irritation in one and headache and nausea in the other. There were not particularly problematic changes in the laboratory test values of the two cases. Based on the above results, the efficacy and safety of R 50547 nasal spray were confirmed in the treatment of perennial allergic rhinitis in children.View full abstractDownload PDF (22388K)
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