TRIAL OF ASTHMA PATIENT EDUCATION

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项拟议研究的具体目的是进行多中心、随机、双掩蔽、2x2析因设计的临床试验，比较已知对哮喘有效的白三烯抑制剂孟鲁司特和惰性安慰剂。孟鲁司特和安慰剂治疗的颗粒裤将进一步随机接受研究治疗的强化介绍，与中性介绍相比，该治疗旨在增加治疗益处的预期。增强的演示小组将收到关于该药物及其益处的标准化计算机演示，以及诊所工作人员的简短脚本信息。另一个随机分配的第五治疗组将不会接受额外的治疗，从而构成常规护理对照组。主要的结果衡量指标是在四周的随访期间，哮喘日记测量的每日早晨最大呼气流速与两周基线相比的变化。次要结果包括肺功能、峰值流量变异性、哮喘症状、病情恶化的控制、生活质量和卫生保健使用。这项研究是美国肺脏协会哮喘临床研究中心正在进行的合作的一部分，该中心是一个由美国各地的19个研究中心组成的小组。每个研究中心都有多个合作地点，在这些地点将根据这一协议观察受试者。我们网站的所有考察访问都将在GCRC进行。

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. The specific aim of the proposed research is to conduct a multicenter, randomized, double-masked, 2x2 factorial design, clinical trial comparing montelukast, a leukotriene inhibitor with known efficacy in asthma, to inert placebo. The montelukast and placebo-treated particpants will be further randomized to receive either enhanced presentation of the study treatment designed to increase expectancy of therapeutic benefit compared to neutral presentation. The enhanced presentation group will receive a standardized computer-based presentation about the drug and its benefits as well as brief scripted messages from the clinic staff. An additional randomly assigned fifth treatment group will receive no additional treatment, thereby constituting a usual care control group. The primary outcome measure is the change in daily morning peak expiratory flow rate measured by asthma diary during the four week follow-up compared to a two week baseline. Secondary outcomes include measures of lung function, variability of peak flow, asthma symptoms, control of exacerbations, quality of life, and health care use. This study is part of a collaboration being conducted by the American Lung Association Asthma Clinical Research Centers, a group of 19 study centers throughout the U.S. Each study center has multiple collaborating sites at which subjects will be seen under this protocol. All study visits for our site will take place at the GCRC.