Status:
WITHDRAWN
Effect of an Inhaled Glucocorticoid-long-acting Beta Adrenergic Agonist on Endothelial Function in COPD
Lead Sponsor:
University of Miami
Conditions:
COPD
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
In the present study, the investigators wish to address the effect of a glucocorticoid/long-acting beta-agonist preparation on endothelial function in COPD patients who do not currently smoke (ex-smok...
Detailed Description
To test the premise and to characterize the time dependence of the responses, the investigators propose the following two aims: 1. To determine the effect of a medium dose glucocorticoid/long-acting ...
Eligibility Criteria
Inclusion
- Smoking history of at least 10 pack-years and to have quit smoking at least 1 year before the study. -Diagnosis of COPD
- Post-bronchodilator FEV1 of less than 75% of predicted and FEV1/FVC ratio less than 0.7 (GOLD stage ≥2).
- At entry into the study, the subjects will have to be clinically stable; they will be allowed to use short-acting and long-acting β2 - adrenergic agonists and cholinergic antagonists as their usual airway medication.
Exclusion
- Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women.
- Use of cardiovascular medications that cannot be held on the study days
- Use of oral airway medications or anti-inflammatory agents
- Subjects with known beta-adrenergic agonist or NTG intolerance
- Acute respiratory infection within four weeks prior to the study
- A body mass index \> 30
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01209715
Start Date
October 1 2010
End Date
May 1 2012
Last Update
August 1 2014
Active Locations (1)
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1
University of Miami School of Medicine
Miami, Florida, United States, 33136