Status:
COMPLETED
Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers
Lead Sponsor:
University of Miami
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Tobacco Abuse Smoke
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
The hypothesis underlying the proposed study is that the blunted endothelium-dependent vasodilation seen in the airway of current smokers is also present in the brachial artery, and that the same inha...
Detailed Description
Cigarette smoking can lead to systemic endothelial dysfunction. Since the airway circulation is exposed to a high concentration of cigarette smoke constituents, we reasoned that airway vascular endoth...
Eligibility Criteria
Inclusion
- For both healthy non-smokers and healthy current smokers:
- normal spirometry Healthy current smokers: history of \>10 pack-year smoking
Exclusion
- Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. Cardiovascular disease and/or use of cardiovascular medications. Subjects with known beta-adrenergic agonist or nitroglycerin intolerance. A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis).
- Acute respiratory infection within four weeks prior to the study. Use of any airway medication. FEV1 \< 80% of predicted and FEV1/FVC \< 0.7. A body mass index \> 30.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01216735
Start Date
September 1 2008
End Date
September 1 2010
Last Update
June 29 2016
Active Locations (1)
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1
Human Research Laboratory - University of Miami
Miami, Florida, United States, 33136