TIOTROPIUM BROMIDE ADMINISTERED VIA THE RESPIMAT DEVICE IN CF PATIENTS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项随机、剂量内双盲、安慰剂对照研究，旨在调查每日通过Respimate设备增加单剂和多剂(28天剂量)硫托溴铵治疗囊性纤维化患者的安全性、耐受性和药代动力学。符合纳入/排除标准的受试者将在CRC中接受单剂量吸入性研究药物治疗，然后在8小时内进行血液、尿液采样、生命体征测量和肺活量测定。受试者可以选择在那里结束研究，或者继续研究的多剂量部分(在家服药，每天一次，连续28天)。如果受试者选择同时进行单剂量和多剂量部分的研究，他们必须在两次剂量之间有30天的时间，并将获得相同的剂量。

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. This is a randomized, double-blind within dose, placebo-controlled study to investigate the safety, tolerability and pharmacokineetics of increasing single and multiple doses (28-day dosing) of tiotropium bromide administered once daily via the Respimate device in people with cystic fibrosis. Subjects meeting inclusion/exclusion criteria will receive a single dose of inhaled study medication in the CRC followed by blood, urine sampleing, vital sign measurement and spirometry over 8 hours. Subjects may opt to end the study there or proceed to the multiple dose part of the study (take medication at home, once a day for 28 days). If subjects opt to do both the single and multiple dose part of the study, they must have 30 days in between the dosing And will receive the same dose.