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• Status: Withdrawn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