THE LEUKOTRIENE MODIFIER OR CORTICOSTEROID OR CORTICOSTEROID-SALMETEROL TRIAL

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。本试验的目的是比较小剂量吸入皮质类固醇、白三烯调节剂和皮质类固醇-沙美特罗联合用药对低剂量吸入皮质类固醇控制良好的哮喘患者的疗效。这将是一项双盲研究；治疗医生和研究参与者都不知道正在接受哪种治疗。共有33名哮喘受试者(全国495名)将在明尼苏达州接受大约6个月的治疗。主要的结果衡量标准将是治疗失败，即哮喘加重或肺功能突然恶化的频率增加。这项研究是由美国肺脏协会哮喘临床研究中心进行的合作的一部分，该中心由美国各地的19个研究中心组成。每个研究中心都有多个合作地点，根据该协议，受试者将在这些地点看到。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 purpose of this trial is to compare low dose inhaled corticosteroid vs leukotriene modifier vs corticosteroid-salmeterol combination for asthmatic patients well controlled on low dose inhaled corticosteroids. This will be a double-blind study; neither the treating doctors nor the study participants will know which treatment is being received. A total of 33 asthmatic subjects (495 nationwide) will be treated in MN for approximately six months. The main outcome measure will be treatment failure, i.e. increased frequency of asthma exacerbations or sudden worsening of lung functions. 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 US. 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.