Effect of an Inhaled Glucocorticoid-long-acting Beta Adrenergic Agonist on Endothelial Function in COPD
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: COPD
In brief
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-smokers) by measuring endothelium-dependent (albuterol response) and endothelium-independent (NTG response) vasodilation in the bronchial artery, reflecting endothelium-dependent and endothelium-independent vasodilation (drug-induced increase in Qaw, ΔQaw). With this approach the investigators will test the hypothesis that in stable ICS-naïve COPD patients, endothelium-dependent vasodilation is restored with a glucocorticoid/long-acting beta-agonist preparation, presumably resulting from the glucocorticoid component.
Key facts
- Study ID
- NCT01209715
- Run by
- University of Miami
- People needed
- 0
- Starts
- 2010-10-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2014-08-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Miami School of Medicine — Miami, Florida, United States
Full record on ClinicalTrials.gov
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