Tiotropium Bromide in Cystic Fibrosis

NCT01179347 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2013-12-24

Study results available

Summary

To date, there have been no formal clinical studies completed using tiotropium in CF patients. While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis. Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric and adult CF. The phase III trial (205.438) is a part of the approved Paediatric Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.

Conditions

Cystic Fibrosis

Interventions

DRUG

tiotropium Respimat® inhaler

to evaluate safety and efficacy tiotropium delivered with Respimat® inhaler compared to placebo.

DRUG

Placebo Respimat® inhaler

patient to receive placebo matching active drug once daily

Sponsors & Collaborators

Boehringer Ingelheim
lead INDUSTRY

Principal Investigators

Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: DOUBLE
Model: PARALLEL

Eligibility

Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2010-09-30
Primary Completion: 2012-03-31

Countries

United States
Australia
Austria
Belgium
Canada
Czechia
France
Germany
Hungary
Ireland
Israel
Italy
Poland
Portugal
Russia
Slovakia
South Africa
Spain
Switzerland
United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Cystic Fibrosis

Companies

Boehringer Ingelheim