TIOTROPIUM BROMIDE ADMINISTERED VIA THE RESPIMAT DEVICE IN CF PATIENTS

通过 RESPIMAT 装置对 CF 患者施用噻托溴铵

• 批准号: 7604920
• 负责人: RICHARD C AHRENS
• 金额: $ 0.05万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604920
• 关键词: Blood; Breathing; Computer Retrieval of Information on Scientific Projects Database; Cystic Fibrosis; Daily; Devices; Dose; Double-Blind Method; Exclusion Criteria; Funding; Grant; Home environment; Hour; Institution; Measurement; Patients; Pharmaceutical Preparations; Randomized; Research; Research Personnel; Resources; Safety; Source; Spirometry; United States National Institutes of Health; Urine; day; placebo controlled study; tiotropium bromide

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项随机、双盲剂量内安慰剂对照研究，旨在调查囊性纤维化患者通过 Respimate 装置每日一次增加单次和多次剂量（28 天给药）噻托溴铵的安全性、耐受性和药代动力学。 符合纳入/排除标准的受试者将在 CRC 中接受单剂吸入研究药物，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继续进行研究的多剂量部分（在家服药，每天一次，持续 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，他们在两次给药之间必须间隔 30 天，并且将接受相同的剂量。