N/A N=15 Randomized Double-blind

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

Tobacco Abuse Smoke

Bottom Line

View on ClinicalTrials.gov: NCT01216735 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo — 40.9; 0.0 % change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Fluticasone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo	40.9; 0.0	—
SECONDARY Flow-mediated Brachial Vasodilation (FMD% Peak Delta)	3.9; 4.8	—

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.

Eligibility Criteria

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 30.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01216735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.