Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers

Completed · Not applicable · Has a placebo group

Conditions studied: Tobacco Abuse Smoke

In brief

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 inhaled corticosteroid (ICS) treatment regime that reversed endothelial function in the airway of current smokers will also restore endothelium-dependent relaxation in the brachial artery. Non-smokers will be used as controls and will not receive any intervention or treatment.

Key facts

Study ID

NCT01216735

Run by

University of Miami

People needed

32

Starts

2008-09-01

Expected to finish

2010-09-01

Last updated by the study team

2016-06-29

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For both healthy non-smokers and healthy current smokers:
• normal spirometry Healthy current smokers: history of >10 pack-year smoking

You may not qualify if…

• 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.

Where it is running

• Human Research Laboratory - University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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