DOSE OF INHALED CORTICOSTEROIDS W/ EQUISYSTEMIC EFFECTS (DICE)

本研究的目的是比较六种不同吸入性皮质类固醇之间估计的肾上腺抑制。 将招募不需要皮质类固醇治疗的轻度哮喘患者作为本多中心研究的一部分。 患者将随机接受安慰剂或吸入性类固醇，剂量逐渐递增，尽管每例患者将在第一个过夜研究阶段吸入安慰剂。 在安慰剂治疗后的四个通宵测试中，患者将吸入安慰剂或类固醇，剂量逐渐增加。 在每次研究阶段，受试者将采集尿液用于皮质醇检测。 在晚上10点吸入研究药物或安慰剂后，还将在整个晚上每小时采集一次皮质醇血样。 结果变量将观察肾上腺抑制，如血浆皮质醇和尿皮质醇排泄曲线下面积所示。 将比较不同吸入类固醇之间的剂量反应关系，并确定等系统剂量。

The purpose of this study is to compare the estimated adrenal suppression between six different inhaled corticosteroids. Patients with mild asthma not requiring corticosteroid therapy will be recruited as part of this multicenter study. Patients will be randomized to receive either placebo or an inhaled steroid at progressively escalating doses although each patient will inhale a placebo on the first overnight study session. At each of four overnight testing sessions following the placebo session, the patients will inhale either a placebo or steroid at progressively increasing doses. On each study session, the subjects will collect urine for cortisol. They will also have hourly blood samples drawn for cortisol throughout the night following a inhalation of the study drug or placebo at 10 PM. Outcome variables will look at adrenal suppression as indicated by the area under the curve of plasma cortisols and the urine cortisol excretion. Dose response relationships will be compared between the different inhaled steroids and equisystemic doses will be determined.