Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment (smoker3)

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 Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Procedure: echocardiogram plus albuterol; Procedure: airway blood flow plus albuterol; Drug: Fluticasone propionate; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: smokers; participants with smoking history ( > 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation	Procedure: echocardiogram plus albuterol; participants will performed echocardiogram before and 15 minutes after inhaled albuterol; Procedure: airway blood flow plus albuterol; participants will performed echocardiogram before and 15 minutes after inhaled albuterol; Other Names: Qaw; Drug: Fluticasone propionate; participant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer); Drug: placebo; participant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer).
Experimental: non-smokers; healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation	Procedure: echocardiogram plus albuterol; participants will performed echocardiogram before and 15 minutes after inhaled albuterol; Procedure: airway blood flow plus albuterol; participants will performed echocardiogram before and 15 minutes after inhaled albuterol; Other Names: Qaw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway Blood Flow	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	before and 15 minutes after albuterol inhalation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiogram	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	MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers

Collaborators and Investigators

• Sponsor: University of Miami

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 25, 2014
• First Submitted That Met QC Criteria: May 16, 2014
• First Posted (Estimate): May 19, 2014

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: smokers; echocardiogram; fluticasone; airway blood flow
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Fluticasone; Xhance; Albuterol
• Other Study ID Numbers: 20120896