TRIAL OF ASTHMA PATIENT EDUCATION

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。该研究的具体目的是进行一项多中心、随机、双盲、2x2因子设计的临床试验，比较孟鲁司特（一种已知对哮喘有效的白三烯抑制剂）与惰性安慰剂。孟鲁司特和安慰剂治疗的参与者将进一步随机化，接受增强的研究治疗，与中性治疗相比，旨在增加治疗益处的预期。强化陈述组将收到一个标准化的基于计算机的关于药物及其益处的陈述，以及来自临床工作人员的简短的脚本信息。另一个随机分配的第五治疗组将不接受额外治疗，从而构成常规护理对照组。主要结局指标是4周随访期间哮喘日记测量的每日早晨峰值呼气流量的变化，与2周基线相比。次要结局包括肺功能、峰值血流变异性、哮喘症状、恶化控制、生活质量和医疗保健使用。本研究是由美国肺脏协会哮喘临床研究中心进行的一项合作的一部分，该研究中心由遍布美国的19个研究中心组成，每个研究中心都有多个合作地点，受试者将根据本协议进行观察。我们网站的所有研究访问都将在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.