Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
Completed · Phase 3 · Has a placebo group
Conditions studied: Pulmonary Disease, Chronic Obstructive
In brief
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.
Key facts
- Study ID
- NCT00931385
- Run by
- Boehringer Ingelheim
- People needed
- 99
- Starts
- 2009-06-01
- Last updated by the study team
- 2014-07-01
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 1222.24.24011 Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
- 1222.24.24009 Boehringer Ingelheim Investigational Site — Overland Park, Kansas, United States
- 1222.24.24007 Boehringer Ingelheim Investigational Site — Lafayette, Louisiana, United States
- 1222.24.24002 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
- 1222.24.24010 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
- 1222.24.24004 Boehringer Ingelheim Investigational Site — Easley, South Carolina, United States
- 1222.24.24006 Boehringer Ingelheim Investigational Site — Gaffney, South Carolina, United States
- 1222.24.24005 Boehringer Ingelheim Investigational Site — Greenville, South Carolina, United States
- 1222.24.24008 Boehringer Ingelheim Investigational Site — Greenville, South Carolina, United States
- 1222.24.24001 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
- 1222.24.24003 Boehringer Ingelheim Investigational Site — Union, South Carolina, United States
Full record on ClinicalTrials.gov
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