THE TRIAL OF ASTHMA PATIENT EDUCATION (TAPE)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。安慰剂反应通常被认为是对惰性药物的虚假、非特异性或混淆反应，医疗人员故意开具安慰剂处方被认为是不光彩的。有证据表明，安慰剂治疗不仅能引起症状反应，还能引起神经元和免疫反应，这提高了利用安慰剂反应的成分来增强药理活性治疗效果的可能性。哮喘是一种慢性疾病，对安慰剂吸入的急性生理反应已被记录，但没有研究关注长期安慰剂效应。在临床试验中给予安慰剂治疗的患者通常表现出改善，但这种现象的机制尚不清楚。如果我们能更好地理解这种安慰剂反应，我们可能能够利用这些机制来改善哮喘治疗。我们建议进行一项随机临床试验，采用2X2析因设计和常规护理对照组，以解决有关哮喘安慰剂效应的重要未解问题。我们将通过改变向患者展示药物的方式来改变参与者对药物有益的期望，使用标准化的治疗演示，试图改变药物的知识、信念和象征意义。来自19个不同临床中心的大约600名受试者将参与这项研究。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Placebo responses have often been considered to be false, non-specific, or confounding responses to inert medications, and the intentional prescription of placebos by healthcare personnel has been considered disreputable. Evidence that placebo treatments can not only evoke symptomatic responses but also can evoke neuronal and immunologic responses has raised the possibility that components of the placebo response can be harnessed to augment the effect of pharmacologically active treatment. Asthma is a chronic disorder in which acute physiological responses to placebo inhalation has been documented, but there is no research focusing on longer-term placebo effects. Patients assigned placebo treatment in clinical trials usually show improvement, but the mechanism of this phenomenon is not understood. If we can better understand this placebo response, we may be able to use these mechanisms to improve asthma therapy. We propose to conduct a randomized clinical trial using a 2X2 factorial design plus a usual-care control group to address important unanswered questions about the placebo effect in asthma. We will alter the expectancy of participants that the drug will be of benefit by varying the manner in which the drug is presented to patients, using standardized treatment presentations that seek to alter the knowledge, beliefs and symbolic meaning of the drug. Approximately 600 subjects at 19 different clinical centers will take part in this study.