TIOTROPIUM BROMIDE ADMINISTERED VIA THE RESPIMAT DEVICE IN CF PATIENTS

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项随机化、剂量内双盲、安慰剂对照研究，旨在研究囊性纤维化患者通过能倍乐装置每日一次给予噻托溴铵单次和多次递增剂量（28天给药）的安全性、耐受性和药代动力学。 符合入选/排除标准的受试者将在CRC中接受单次吸入研究药物给药，随后在8小时内进行血液、尿液采样、生命体征测量和肺功能测定。 受试者可以选择在那里结束研究或继续研究的多次给药部分（在家服药，每天一次，持续28天）。 如果受试者选择进行研究的单次给药和多次给药部分，他们必须在给药之间有30天，并将接受相同的剂量。

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.