A Randomised, Double-blind, Placebo-controlled Parallel-group Trial to Confirm the Efficacy After 12 Weeks and the Safety of Tiotropium 5 Mcg Administered Once Daily Via the Respimat® Device in Patients With Cystic Fibrosis.
- NCT01179347
- PHASE3
- INTERVENTIONAL
Last updated: 2013-12-24
Purpose of Trial
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.
This study is for people with
Cystic Fibrosis
Interventions being studied
tiotropium Respimat® inhaler
Placebo Respimat® inhaler
Inclusion criteria:
1. 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.
2. Male or female patients (children less than 12 years and adolescents \>12 years).
3. Patients \>=5 years of age must be able to perform acceptable spirometric maneuvers, according to the American Thoracic Society (ATS) standards.
4. Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) \>25% of predicted values.
5. Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1.
6. 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.
7. The patient or the patient's legally acceptable representative must be able to give informed consent.
8. 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.
9. Patients who are on daily inhaled antibiotic use must be stabilized for at least 6 weeks prior to Visit 1 (screening).
10. Patients having previously participated in study 205.339 can also be selected.
Exclusion criteria:
1. Patients with a known hypersensitivity to study drug
2. Patients who have participated in another study with an Investigational drug within one month preceding the screening visit.
3. Patients who are currently participating in another trial. Observational studies are allowed. Permission should be obtained from sponsor of other study.
4. Patients with known relevant substance abuse, including alcohol or drug abuse.
5. Adolescent and adult female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening.
6. Female patients of child bearing potential who are not using a medically approved form of contraception.
7. 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.
ELIGIBILITY
Gender: ALL
Age: 0+
Healthy Volunteers: No
15 Locations
Tuscon
205.438.01004 Boehringer Ingelheim Investigational Site
Arizona, United States
San Diego
205.438.01011 Boehringer Ingelheim Investigational Site
California, United States
Jacksonville
205.438.01018 Boehringer Ingelheim Investigational Site
Florida, United States
Orlando
205.438.01008 Boehringer Ingelheim Investigational Site
Florida, United States
Orlando
205.438.01014 Boehringer Ingelheim Investigational Site
Florida, United States
Orlando
205.438.01021 Boehringer Ingelheim Investigational Site
Florida, United States
Indianapolis
205.438.01007 Boehringer Ingelheim Investigational Site
Indiana, United States
South Bend
205.438.01006 Boehringer Ingelheim Investigational Site
Indiana, United States
Detroit
205.438.01001 Boehringer Ingelheim Investigational Site
Michigan, United States
Manchester
205.438.01010 Boehringer Ingelheim Investigational Site
New Hampshire, United States
Syracuse
205.438.01003 Boehringer Ingelheim Investigational Site
New York, United States
Cleveland
205.438.01019 Boehringer Ingelheim Investigational Site
Ohio, United States
Oklahoma City
205.438.01013 Boehringer Ingelheim Investigational Site
Oklahoma, United States
Charleston
205.438.01005 Boehringer Ingelheim Investigational Site
South Carolina, United States
Milwaukee
205.438.01012 Boehringer Ingelheim Investigational Site
Wisconsin, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov