Tiotropium Bromide in 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.