Status:
COMPLETED
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00931385
Start Date
June 1 2009
Last Update
July 1 2014
Active Locations (11)
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1
1222.24.24011 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
2
1222.24.24009 Boehringer Ingelheim Investigational Site
Overland Park, Kansas, United States
3
1222.24.24007 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
4
1222.24.24002 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States