Studies Open for Enrollment

A Study to Investigate Increasing Single and Multiple Doses of Tiotropium Bromide Administered Daily via the Respimat Device in Cystic Fibrosis Patients

The purpose of this study is to determine the safety and tolerability of tiotropium bromide using the Respimat device when compared to a placebo inhaler in cystic fibrosis (CF) subjects. Tiotropium bromide is a long-acting bronchodilator. The Respimat device uses a liquid solution of tiotropium that is inhaled by the mouth, and has shown that more of the drug reaches the lung as compared to other metered devices and dry powder inhalers. Approximately 15 subjects will be enrolled in this study, which will take place at the Pediatric Clinical Translational Research Center at Children’s Hospital of Pittsburgh of UPMC.

Candidates
Patients with CF ages 6 to 18 will be included in this study.
Boys: 6 to 18 Years
Girls: 6 to 18 Years

Requirements
At the initial screening, through randomized selection, patients will be given either Tiotropium or a placebo to be used with the inhaler during the 6-week study. All three visits will include a physical, blood work, sputum and urine samples and lung function tests. Subjects should plan on all visits lasting up to 9 hours.
Visits: 3
Duration: 6 weeks

Status: Open for Enrollment

How to Participate
To get started, please contact either:
Elizabeth Hartigan, RN
Sandy Hurban, RN
Adrienne Horn, RN
1-877-296-9026

Additional Resources
Cystic Fibrosis

Principal Investigator
Jonathan Finder, MD
Pulmonary Medicine, Allergy and Immunology

Source of Support
Boehringer Ingelheim Pharmaceuticals, Inc.