At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.
In Brief
A Phase 2 clinical trial evaluating Placebo Respimat, Tiotropium bromide 5 mcg, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 510 participants across 107 sites in 11 countries.
Detailed Summary
This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations
Study Details
Timeline
Interventions
patient to receive placebo matching active drug once daily
patient to recieve high dose tiotropium once daily
patient to receive low dose tiotropium once daily