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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Bromides; Tiotropium Bromide

Criteria

Inclusion criteria:

1. Male or female patients

2. Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations)

3. Pre-bronchodilator FEV1 greater/equal 25% of predicted values

Exclusion criteria:

1. Significant history of allergy/hypersensitivity

2. Hypersensitivity to study drug

3. Participation in another trial

4. Female patients who are pregnant or lactating

5. Female patients of childbearing potential

6. Patients who have started a new medication for CF within 4 weeks of screening

7. Patients with known substance abuse

8. Clinically significant disease other than CF