CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Fluticasone propionate +3 moredrug
Likely dose
Fluticasone propionate 220 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02141633
NCT02141633N/ACompleted

Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment

University of Miami·interventional·Posted May 19, 2014·Updated Dec 16, 2016

In Brief

A clinical study evaluating echocardiogram plus albuterol, airway blood flow plus albuterol, and 2 other interventions for Smoking. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2) compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic parameters. With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 19, 2014
Enrollment StartApr 1, 2013
Primary CompletionJun 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.1 years ago

Interventions

echocardiogram plus albuterolprocedure

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

airway blood flow plus albuterolprocedure

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

Fluticasone propionatedrug

participant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer)

placebodrug

participant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer).