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

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Procedure: echocardiogram plus albuterol; Procedure: airway blood flow plus albuterol; Drug: Fluticasone propionate; Drug: placebo

• Registration Number: NCT02141633
• Lead Sponsor: University of Miami

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).

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-19
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Results First Submitted: 2016-07-07
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-25
• Last Update Submitted: 2016-10-25
• Results First Posted: 2016-12-16
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
smokers	echocardiogram plus albuterol	participants with smoking history ( \> 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
non-smokers	echocardiogram plus albuterol	healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
smokers	placebo	participants with smoking history ( \> 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
non-smokers	airway blood flow plus albuterol	healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
smokers	airway blood flow plus albuterol	participants with smoking history ( \> 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation
smokers	Fluticasone propionate	participants with smoking history ( \> 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation

Primary Outcome Measures

Name	Time	Method
Airway Blood Flow	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 Outcome Measures

Name	Time	Method
Echocardiogram	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

Trial Locations

Locations (1)

University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States