Clinical trial NCT02141633: Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment
Official title: Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smokers
airway blood flow
fluticasone
echocardiogram
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 31
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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).

Eligibility criteria: Inclusion Criteria:

* 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.

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 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
* Abnormal pulmonary function

Primary outcomes:
measure: Airway Blood Flow
timeFrame: before and 15 minutes after albuterol inhalation
Secondary outcomes:
measure: Echocardiogram
timeFrame: MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Adam Wanner, MD
role: PRINCIPAL_INVESTIGATOR
References: