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Completed

NCT Number: NCT02141633

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

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.

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Key information

Conditions

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami School of Medicine

Miami, Florida, 33136, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

echocardiogram plus albuterol

Procedure

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

airway blood flow plus albuterol

Procedure

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

Other names: Qaw

Fluticasone propionate

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Airway Blood Flow

    Time frame: before and 15 minutes after albuterol inhalation

    compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers

Secondary outcomes

  1. Echocardiogram

    Time frame: MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers

    to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Acronym: smoker3

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 19, 2014
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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