Clinical trial NCT02141633
Conditions: Smoking
Keywords: smokers airway blood flow fluticasone echocardiogram
Sponsor: University of Miami
Start date: 2013-04-01; Completion date: 2015-12-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
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.

Fifteen healthy current smokers with a \>10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited There will be 1-4 visits to the laboratory (one for non-smokers, 4 for smokers). All subjects will have the first visit. Current smokers will have 3 additional visits. Current smokers will be asked not to smoke before coming to the laboratory on the 3 study days. All subjects will be instructed to abstain from ingesting alcoholic beverages, coffee or caffeinated drinks for at least 12 hours the night before each study day. The subjects will also be instructed not to use PDE5 inhibitors for 24 hours before coming to the laboratory. On each study day, the protocol will start at the same time (in the morning).

Arms: arm 1: participants with smoking history ( \> 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation arm 2: healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
Interventions: intervention 1: echocardiogram plus albuterol intervention 2: airway blood flow plus albuterol intervention 3: Fluticasone propionate intervention 4: placebo
Intervention descriptions: intervention 1: participants will performed echocardiogram before and 15 minutes after inhaled albuterol intervention 2: participants will performed echocardiogram before and 15 minutes after inhaled albuterol intervention 3: participant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer) intervention 4: participant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer).

Protocol documents: