THE LEUKOTRIENE MODIFIER OR CORTICOSTEROID OR CORTICOSTEROID-SALMETEROL TRIAL

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。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（IC）的方法。这项由制药商发起的19个中心的中度哮喘替代治疗试验假设如下：1）白三烯受体拮抗剂（LTRA）可以取代每日两次的低剂量IC，而不会失去控制。2)半日剂量的IC加沙美特罗可以取代每日两次的IC。3)LTRA或联合治疗可以取代每日两次的IC。一项类似的研究已经获得批准，但沙美特罗是唯一被取消的目标，因为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。将研究超过450名受试者。有一个多月的导入期，然后随机分为3组：孟鲁司特10 mg; 1/2 IC（100 mg）+沙丁胺醇（50 mg）; IC（100 mg，每日两次）。结果的测量将包括日记、呼气峰流量、症状和生活质量;一些中心将包括乙酰甲胆碱激发。这项研究最近在GCRC上启动。暂时没有结果。

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.