A Clinical Study on Bronchodiator ST1512 by the Double Blind Trial Method

Gomi Jiro, 光井 庄太郎, 工藤 康之, 赤坂 喜三郎, 小野 康夫, 木村 武, 川上 保雄, 野口 英世, 宮本 昭正, 牧野 荘平, 可部 順三郎, 石崎 達, 中島 重徳, 熊谷 朗, 野崎 忠信, 富岡 玖夫, 伊藤 和彦, 斧田 太公望

doi:10.15036/arerugi.22.599

To investigate the effect of bronchodilator ST1512 (S group) in instant and continuous uses on adult bronchial asthma, a double blind trial was performed in 9 institutes by using metaproterenol (A group) and inactive placebo (P group) as controls. The result of an open trial was analyzed according to the Fisher's direct probability computation method, and the number of samples necessary for this double blind trial was found to be 36 cases per group. Accordingly, it follows that 108 cases or so will do for three groups. Therefore, an interim inspection was done, when the number of samples reached 105 cases. The samples tested totaled 104 cases, made up as follows: S group (34 cases), A group (36 cases) and P group (34 cases). And there was no significant difference in back ground among the three groups. As to the test method, one tablet eact was administered to all the patients in groups S (ST1512 lmg), A (metaproterenol 10 mg) and P (placebo). Subjective and objective symptoms and lung functions were examined before and 1 hour after the drug administration. H-test and U-test were conducted on general assessments of doctors. These tests revealed that there was a significant difference in the drug effect between S and P groups at less than 0.5% level but that there were no significant differences between S and A group and between A and P groups at a 5% level. Next, a detailed discrimination analysis among the three groups was also carried out.

A Clinical Study on Bronchodiator ST1512 by the Double Blind Trial Method

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