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Therapeutic Areas: Pulmonary/Respiratory Diseases
Disease Category: Cystic Fibrosis
Trial Information
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
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.
Patient 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
Patient 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
Kelly Colucci, Manager, Grants and Contracts
Atlantic Health System
475 South Street
Morristown, NJ 07962
Phone: 973-660-3139
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Research Center Information: Atlantic Health System
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