The purpose of this study is to compare the effects of e-cigarettes and continued smoking on pulmonary and cardiac outcomes in a population with established pulmonary disease.
E-cigarettes with nicotine can affect important cardiopulmonary outcomes and likely pose less risk than cigarettes, but they are not harmless. Given the existing literature, there is a need for controlled trials of e-cigarette use in populations with cardiopulmonary disease to fill the gaps between these existing examinations. Clarifying how the pulmonary and cardiac effects of e-cigarettes compare to use of conventional cigarettes in those with cardiopulmonary disease beyond single acute exposures will provide important new health information that can help inform policy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
21
Altering the availability of e-cigarettes
Altering the availability of financial incentives for abstaining from combustible cigarettes
Vermont Center on Behavior and Health
Burlington, Vermont, United States
Baseline FEV1/FVC Ratio
Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry
Time frame: Intake assessment
Change from Baseline FEV1/FVC Ratio each day
Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry
Time frame: Daily through study completion, an average of 4 weeks
Change from Baseline FEV1/FVC Ratio at 2 weeks
Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry
Time frame: Assessment completed 2 weeks after intake assessment
Change from Baseline FEV1/FVC Ratio at 4 weeks
Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Lung Reactance at 5Hz (X5)
Measurement of the ability of the lung to store energy, as measured by oscillometry
Time frame: Intake assessment
Change from Baseline Lung Reactance at 5Hz (X5) at 2 weeks
Measurement of the ability of the lung to store energy, as measured by oscillometry
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Time frame: Assessment completed 2 weeks after intake assessment
Change from Baseline Lung Reactance at 5Hz (X5) at 4 weeks
Measurement of the ability of the lung to store energy, as measured by oscillometry
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19)
Airway impedence in the lungs as measured by oscillometry
Time frame: Intake assessment
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks
Airway impedence in the lungs as measured by oscillometry
Time frame: Assessment completed 2 weeks after intake assessment
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 4 weeks
Airway impedence in the lungs as measured by oscillometry
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Oxygen Saturation (SpO2)
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Time frame: Intake assessment
Change from Baseline Oxygen Saturation (SpO2) each day
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Time frame: Daily through study completion, an average of 4 weeks
Change from Baseline Oxygen Saturation (SpO2) at 2 weeks
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Time frame: Assessment completed 2 weeks after intake assessment
Change from Baseline Oxygen Saturation (SpO2) at 4 weeks
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Fractional Exhaled Nitric Oxide (FeNO)
Amount of nitric oxide in the breath
Time frame: Intake assessment
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks
Amount of nitric oxide in the breath
Time frame: Assessment completed 2 weeks after intake assessment
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks
Amount of nitric oxide in the breath
Time frame: Assessment completed 4 weeks after intake assessment
Baseline COPD Assessment Test Score
Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
Time frame: Intake assessment
Change from Baseline COPD Assessment Test Score at 2 weeks
Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
Time frame: Assessment completed 2 weeks after intake assessment
Change from Baseline COPD Assessment Test Score at 4 weeks
Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
Time frame: Assessment completed 4 weeks after intake assessment
Baseline St. George's Respiratory Questionnaire for COPD Patients Score
Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health
Time frame: Intake assessment
Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 2 weeks
Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health
Time frame: Assessment completed 2 weeks after intake assessment
Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 4 weeks
Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Blood Pressure
Force exerted by blood against the walls of the arteries
Time frame: Intake assessment
Change from Baseline Blood Pressure each day
Force exerted by blood against the walls of the arteries
Time frame: Daily through study completion, an average of 4 weeks
Change from Baseline Blood Pressure at 2 weeks
Force exerted by blood against the walls of the arteries
Time frame: Assessment completed 2 weeks after intake assessment
Change from Baseline Blood Pressure at 4 weeks
Force exerted by blood against the walls of the arteries
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Heart Rate
Number of time the heart beats per minute
Time frame: Intake assessment
Change from Baseline Heart Rate each day
Number of time the heart beats per minute
Time frame: Daily through study completion, an average of 4 weeks
Change From Baseline Heart Rate at 2 weeks
Number of time the heart beats per minute
Time frame: Assessment completed 2 weeks after intake assessment
Change From Baseline Heart Rate at 4 weeks
Number of time the heart beats per minute
Time frame: Assessment completed 4 weeks after intake assessment