CompletedNot Applicable

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

United States32 participantsStarted 2008-09

Plain-language 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 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.

Who can participate

Age range30 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: For both healthy non-smokers and healthy current smokers: normal spirometry Healthy current smokers: history of \>10 pack-year smoking Exclusion Criteria: 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.

What they're measuring

Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo

Timeframe: 3 weeks treatment period of ICS or placebo

Trial details

NCT IDNCT01216735

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-12

Results submitted2014-09-05

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