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。在轻度哮喘患者中，可能有一种替代每日两次吸入皮质类固醇(ICs)的方法。这项由研究人员发起的针对中度哮喘的19中心试验试图尝试替代治疗方法，假设如下：1)白三烯受体拮抗剂(LTRA)可以替代每天两次的小剂量ICs，而不会失去控制。2)每日半量口服沙美特罗可替代每日两次口服。3)LTRA或联合用药可替代每日2次的ICs。一项类似的研究已经获得批准，但当在没有伴随吸入类固醇的情况下使用沙美特罗(一种长效β-2激动剂)治疗的患者死亡率增加时，沙美特罗是唯一被取消的目标。将对450多名受试者进行研究。试验期1个月以上，随机分为3组：孟鲁司特10 mg，沙丁胺醇50 mg，1/2沙丁胺醇100 mg，每日2次，每次100 mg。结果测量将包括日记、呼气峰值流量、症状和生活质量；一些中心将包括乙酰胆碱挑战。这项研究是最近开始的，是关于GCRC的。目前还没有结果。

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. In patients with mild asthma, an alternative to twice-daily inhaled corticosteroids (ICs) might be available. This investigator-initiated 19-center trial on moderate asthma to try alternative treatments hypothesizes the following: 1) Leukotriene receptor antagonist (LTRA) can be substituted for twice-daily low-dose ICs without loss of control. 2) Half daily dose of ICs plus salmeterol can be substituted for twice-daily ICs. 3) LTRA or combination therapy can be substituted for twice-daily ICs. A similar study was already approved, but salmeterol was the only aim removed when increased mortality was seen in patients treated with salmeterol (a long-acting beta-2 agonist) in the absence of concomitant inhaled steroids. Greater than 450 subjects will be studied. There is a run-in period of over a month followed by randomization into 3 groups: montelukast 10 mg; 1/2 IC (100 mg) + salbuterol (50 mg); IC (100 mg twice daily). Outcome measures will include diaries, peak expiratory flow, symptoms, and quality of life; some centers will include a methacholine challenge. This study was recently initiated on the GCRC. No results are available yet.