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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: Tiotropium bromide 5 mcg; Drug: tiotropium bromide-low dose-2.5mcg; Drug: Placebo Respimat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00737100

2008-001156-43 (EudraCT Number)

205.339

Details and patient eligibility

About

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

Enrollment: 510 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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510 participants in 3 patient groups, including a placebo group

Tiotropium Respimat 2.5 mcg

Experimental group

Description:

patient to receive low dose tiotropium once daily

Treatment:

Drug: tiotropium bromide-low dose-2.5mcg

Tiotropium Respimat 5 mcg

Experimental group

Description:

patient to receive high dose tiotropium once daily

Treatment:

Drug: Tiotropium bromide 5 mcg

Placebo Respimat

Placebo Comparator group

Description:

patient to receive placebo once daily

Treatment:

Drug: Placebo Respimat