Overview

Effect of an Inhaled Glucocorticoid-long-acting Beta Adrenergic Agonist on Endothelial Function in COPD

Status:
Withdrawn
Trial end date:
2012-05-01
Target enrollment:
0
Participant gender:
All
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-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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Miami
Treatments:
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-Agonists
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Fluticasone-Salmeterol Drug Combination
Glucocorticoids
Salmeterol Xinafoate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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