Tiotropium Bromide in Cystic Fibrosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01179347

Run by

Boehringer Ingelheim

People needed

464

Starts

2010-09-01

Last updated by the study team

2013-12-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a documented diagnosis of Cystic Fibrosis (CF) (positive sweat chloride >=60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations.
• Male or female patients (children less than 12 years and adolescents >12 years).
• Patients >=5 years of age must be able to perform acceptable spirometric maneuvers, according to the American Thoracic Society (ATS) standards.
• Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) >25% of predicted values.
• Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1.
• No evidence of respiratory tract infection and no pulmonary exacerbation requiring use of intravenous/oral/inhaled antibiotics, or oral corticosteroids within 2 weeks of screening.
• The patient or the patient's legally acceptable representative must be able to give informed consent.
• Patients who are on a cycling TOBI® regimen must have completed at least 2 cycles every other month TOBI® administration prior to the screening visit.
• Patients who are on daily inhaled antibiotic use must be stabilized for at least 6 weeks prior to Visit 1 (screening).
• Patients having previously participated in study 205.339 can also be selected.

You may not qualify if…

• Patients with a known hypersensitivity to study drug
• Patients who have participated in another study with an Investigational drug within one month preceding the screening visit.
• Patients who are currently participating in another trial. Observational studies are allowed. Permission should be obtained from sponsor of other study.
• Patients with known relevant substance abuse, including alcohol or drug abuse.
• Adolescent and adult female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening.
• Female patients of child bearing potential who are not using a medically approved form of contraception.
• Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. Patients with diabetes may participate if their disease is under good control prior to screening.

Where it is running

• 205.438.01011 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 205.438.01018 Boehringer Ingelheim Investigational Site — Jacksonville, Florida, United States
• 205.438.01008 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 205.438.01014 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 205.438.01021 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 205.438.01007 Boehringer Ingelheim Investigational Site — Indianapolis, Indiana, United States
• 205.438.01006 Boehringer Ingelheim Investigational Site — South Bend, Indiana, United States
• 205.438.01001 Boehringer Ingelheim Investigational Site — Detroit, Michigan, United States
• 205.438.01010 Boehringer Ingelheim Investigational Site — Manchester, New Hampshire, United States
• 205.438.01003 Boehringer Ingelheim Investigational Site — Syracuse, New York, United States
• 205.438.01019 Boehringer Ingelheim Investigational Site — Cleveland, Ohio, United States
• 205.438.01013 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 205.438.01005 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 205.438.01012 Boehringer Ingelheim Investigational Site — Milwaukee, Wisconsin, United States
• 205.438.61003 Boehringer Ingelheim Investigational Site — Chermside, Queensland, Australia
• 205.438.61004 Boehringer Ingelheim Investigational Site — Herston, Queensland, Australia
• 205.438.61001 Boehringer Ingelheim Investigational Site — Adelaide, South Australia, Australia
• 205.438.61002 Boehringer Ingelheim Investigational Site — Subiaco, Western Australia, Australia
• 205.438.43001 Boehringer Ingelheim Investigational Site — Innsbruck, Austria
• 205.438.43002 Boehringer Ingelheim Investigational Site — Salzburg, Austria
• 205.438.32002 Boehringer Ingelheim Investigational Site — Brussels, Belgium
• 205.438.32004 Boehringer Ingelheim Investigational Site — Edegem, Belgium
• 205.438.32003 Boehringer Ingelheim Investigational Site — Jette, Belgium
• 205.438.32001 Boehringer Ingelheim Investigational Site — Leuven, Belgium
• 205.438.01004 Boehringer Ingelheim Investigational Site — Tuscon, Arizona, United States

Full record on ClinicalTrials.gov

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