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EFFICACY OF IMMUNOTHERAPY IN MITE ALLERGIC ASTHMA

EFFICACY OF IMMUNOTHERAPY IN MITE ALLERGIC ASTHMA
免疫治疗对螨过敏性哮喘的疗效
批准号:
3546604
负责人:
Stephen I Wasserman
金额:
$24.39万
依托单位国家:
美国
项目类别:
财政年份:
1984
资助国家:
美国
项目状态:
已结题
起止时间:
1984-09-30 至 1990-12-31

项目摘要

项目成果

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中文摘要
翻译
过敏原免疫治疗(IT)治疗哮喘的疗效观察 成年人仍然是一个有争议的问题,因为之前的时间有限和不充分 学习。这项前瞻性的双盲安慰剂对照研究 旨在严格测试螨类免疫疗法引起的假说 尘螨敏感人群的免疫学和临床改善 成年哮喘患者。对尘螨敏感的成年哮喘患者,没有证据表明 严重的非哮喘性心肺疾病,需要定期 非类固醇哮喘药物将进入6个月的基准期。在… 在基准期结束时,他们将被随机分配到一只尘螨或 安慰剂免疫治疗组按高低分层 尘螨对支气管壁的敏感度和尘螨抗原暴露的高低。 在整个基线和治疗期间,受试者将每天保持 症状、用药和最大呼气流速日记;它们将 每月进行临床评估;并将进行家螨环境评估 每3个月获得一次。在基准期间,在维护IT部门 在维修后6个月、1年、2年和3年,稀释性粉尘 皮肤测试,血清粉尘特异性IgE和免疫球蛋白,乙酰甲胆碱敏感性, 和尘螨抗原的支气管挑战将与介体评估 已执行。在研究结束时,临床和免疫学 上述参数将在尘螨和安慰剂组中进行比较,网址为 上述时间间隔。此外,使用协变量 分析、临床或免疫学参数与 将确定对IT的临床反应。
英文摘要
The efficacy of allergen immunotherapy (IT) in the treatment of asthma in adults remains a matter of controversy due to limited and inadequate prior studies. This prospective double-blind placebo controlled study is designed to rigorously test the hypothesis that mite immunotherapy causes immunologic and clinical improvement in a population of mite sensitive adult asthmatics. Mite sensitive, adult asthmatics with no evidence of significant non-asthmatic cardiopulmonary disease who require regular non-steroid asthma medications will enter a 6-month baseline period. At the end of the baseline period, they will be randomized to a mite or placebo immunotherapy group with stratification on the basis of high or low mite bronchial sensitivity and high or low mite antigen exposure. Throughout the baseline and treatment period, subjects will keep daily symptom, medication, and peak expiratory flow rate diaries; they will be clinically evaluated monthly; and home mite environmental assessments will be obtained every 3 months. During the baseline period, at maintenance IT and at 6 months, 1, 2, and 3 years after maintenance IT, dilutional mite skin testing, serum mite-specific IgE and IgG, methacholine sensitivity, and mite antigen bronchial challenge with mediator assessment will be performed. At the end of the study, the clinical and immunologic parameters described above will be compared in mite and placebo groups at the time intervals described above. In addition, using co-variate analysis, clinical or immunologic parameters which correlate with a clinical response to IT will be identified.
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