Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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

Key facts

Study ID

NCT00737100

Run by

Boehringer Ingelheim

People needed

510

Starts

2008-09-01

Last updated by the study team

2014-05-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients
• Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations)
• Pre-bronchodilator FEV1 greater/equal 25% of predicted values

You may not qualify if…

• Significant history of allergy/hypersensitivity
• Hypersensitivity to study drug
• Participation in another trial
• Female patients who are pregnant or lactating
• Female patients of childbearing potential
• Patients who have started a new medication for CF within 4 weeks of screening
• Patients with known substance abuse
• Clinically significant disease other than CF

Where it is running

• 205.339.019 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 205.339.023 Boehringer Ingelheim Investigational Site — Jacksonville, Florida, United States
• 205.339.021 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 205.339.030 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 205.339.031 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 205.339.014 Boehringer Ingelheim Investigational Site — Indianapolis, Indiana, United States
• 205.339.022 Boehringer Ingelheim Investigational Site — Indianapolis, Indiana, United States
• 205.339.013 Boehringer Ingelheim Investigational Site — South Bend, Indiana, United States
• 205.339.001 Boehringer Ingelheim Investigational Site — Iowa City, Iowa, United States
• 205.339.017 Boehringer Ingelheim Investigational Site — Ann Arbor, Michigan, United States
• 205.339.025 Boehringer Ingelheim Investigational Site — Detroit, Michigan, United States
• 205.339.016 Boehringer Ingelheim Investigational Site — Grand Rapids, Michigan, United States
• 205.339.018 Boehringer Ingelheim Investigational Site — Lebanon, New Hampshire, United States
• 205.339.029 Boehringer Ingelheim Investigational Site — Long Branch, New Jersey, United States
• 205.339.009 Boehringer Ingelheim Investigational Site — Morristown, New Jersey, United States
• 205.339.002 Boehringer Ingelheim Investigational Site — Syracuse, New York, United States
• 205.339.024 Boehringer Ingelheim Investigational Site — Cleveland, Ohio, United States
• 205.339.020 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 205.339.032 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 205.339.010 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 205.339.004 Boehringer Ingelheim Investigational Site — Fort Worth, Texas, United States
• 205.339.005 Boehringer Ingelheim Investigational Site — Salt Lake City, Utah, United States
• 205.339.026 Boehringer Ingelheim Investigational Site — Colchester, Vermont, United States
• 205.339.011 Boehringer Ingelheim Investigational Site — Charlottesville, Virginia, United States
• 205.339.006 Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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