Tiotropium Bromide in Cystic Fibrosis



Status:Archived
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2010

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A Randomised, Double-blind, Placebo-controlled Parallel-group Trial to Confirm the Efficacy After 12 Weeks and the Safety of Tiotropium 5 Mcg Administered Once Daily Via the Respimat® Device in Patients With Cystic Fibrosis.


To date, there have been no formal clinical studies completed using tiotropium in CF
patients. While there is a large body of evidence demonstrating the efficacy and safety of
tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little
is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis.
Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic
tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric
and adult CF. The phase III trial (205.438) is a part of the approved Paediatric
Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.



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