Status:
COMPLETED
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 pa...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT00737100
Start Date
September 1 2008
Last Update
May 16 2014
Active Locations (107)
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1
205.339.006 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
2
205.339.019 Boehringer Ingelheim Investigational Site
San Diego, California, United States
3
205.339.023 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
4
205.339.021 Boehringer Ingelheim Investigational Site
Miami, Florida, United States