Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: BI 1744 5 mcg once daily (Drug); BI 1744 10 mcg once daily (Drug); Foradil 12 mcg twice daily (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals
Overall contact:
Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com
Summary
The study is intended to characterize the lung function profile of BI1744 in COPD patients
where patients will perform pulmonary function tests at regular intervals for 24 hours at
the end of a 6 week treatment period. Each patient will receive all four treatments.
Clinical Details
Official title: Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
Study design: Treatment, Crossover Assignment, Safety/Efficacy Study
Primary outcome: The primary objective will be to evaluate whether once daily treatment with 5 mcg or 10 mcg BI
1744 administered via the Respimat device is superior to once daily treatment with Placebo
Respimat using FEV1 AUC values
Secondary outcome: The key secondary objective will be to compare once daily treatment with 5 mcg or 10 mcg BI
1744 administered via the Respimat device to twice daily treatment with Foradil Aerolizer using
FEV1 AUC values. Additional pulmonary and safety measures
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients willing to participate with confirmed diagnosis of COPD
- 40 years of age or older
- having a 10 pack year smoking history
- able to perform serial pulmonary function tests
- able to use both a DPI and Respimat device
Exclusion Criteria:
Significant other disease
- clinically relevant abnormal hematology, chemistry, or urinalysis
- history of asthma
- diagnosis of thyrotoxicosis
- paroxysmal tachycardia related to beta agonists
- history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure
within 1 year
- active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
- significant alcohol or drug use
- pulmonary resection
- taking oral beta adrenergics
- taking unstable oral steroids
- daytime oxygen
- enrolled in rehabilitation program
- enrolled in another study or taking investigational products
- pregnant or nursing women, women of child bearing potential not willing to use two
methods of birth control
- those who are not willing to comply with pulmonary medication washouts
Locations and Contacts
Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com
1222.25.25009 Boehringer Ingelheim Investigational Site, Jasper, Alabama, United States; Recruiting
1222.25.25003 Boehringer Ingelheim Investigational Site, Deland, Florida, United States; Recruiting
1222.25.25002 Boehringer Ingelheim Investigational Site, Clearwater, Florida, United States; Recruiting
1222.25.25007 Boehringer Ingelheim Investigational Site, Winter Park, Florida, United States; Recruiting
1222.25.25010 Boehringer Ingelheim Investigational Site, Austell, Georgia, United States; Recruiting
1222.25.25008 Boehringer Ingelheim Investigational Site, Albuquerque, New Mexico, United States; Recruiting
1222.25.25012 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States; Recruiting
1222.25.25004 Boehringer Ingelheim Investigational Site, Raleigh, North Carolina, United States; Recruiting
1222.25.25011 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States; Recruiting
1222.25.25014 Boehringer Ingelheim Investigational Site, Seneca, South Carolina, United States; Terminated
1222.25.25006 Boehringer Ingelheim Investigational Site, Knoxville, Tennessee, United States; Recruiting
1222.25.25005 Boehringer Ingelheim Investigational Site, Houston, Texas, United States; Completed
1222.25.25013 Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States; Recruiting
Additional Information
Starting date: June 2009
Last updated: October 15, 2009
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