TIOTROPIUM BROMIDE ADMINISTERED VIA THE RESPIMAT DEVICE IN CF PATIENTS

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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.