Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes

Conditions
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Chronic Bronchitis, Emphysema, Asthma-COPD Overlap Syndrome, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: E-Cigarette
* Behavioral: Financial Incentives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 40 years of age or older Current, every day smoker (5 or more cigarettes per day for one year or longer) confirmed with intake CO of 8ppm or greater Established pulmonary disease (chronic obstructive pulmonary disease [COPD], chronic bronchitis, emphysema, or asthma-COPD overlap syndrome) confirmed by physician diagnosis and/or current prescription of medication for treatment (i.e., LABA, LAMA, +/- ICS, or combination) Lives and plans to remain in the greater Burlington, VT area for the next month No intention to quit smoking within the next month Speaks English Exclusion Criteria: Patients who are medically unstable (unstable symptoms, changes in medications or hospitalizations within last 3 months) Inability to conduct in-home measurements.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Combustible Cigarette<br>Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks. | |
| Experimental: E-Cigarette<br>Participants in this arm will smoke electronic cigarettes for two weeks. E-cigarettes (either JUUL or Vuse Alto) and pods (JUUL: Virginia tobacco flavor at 3% or 5% nicotine concentration; Vuse Alto: golden tobacco flavor at 1.8%, 2.4%, or 5% nicotine concentration) will be provided. | Other: E-Cigarette<br>* Altering the availability of e-cigarettes<br>Behavioral: Financial Incentives<br>* Altering the availability of financial incentives for abstaining from combustible cigarettes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Assessment completed 4 weeks after intake assessment | 
| Baseline Fractional Exhaled Nitric Oxide (FeNO) | Amount of nitric oxide in the breath | Intake assessment | 
| Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks | Amount of nitric oxide in the breath | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Assessment completed 4 weeks after intake assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Blood Pressure | Force exerted by blood against the walls of the arteries | Intake assessment | 
| Change from Baseline Blood Pressure each day | Force exerted by blood against the walls of the arteries | 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 | 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 | Assessment completed 4 weeks after intake assessment | 
| Baseline Heart Rate | Number of time the heart beats per minute | Intake assessment | 
| Change from Baseline Heart Rate each day | Number of time the heart beats per minute | 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 | Assessment completed 2 weeks after intake assessment | 
| Change From Baseline Heart Rate at 4 weeks | Number of time the heart beats per minute | Assessment completed 4 weeks after intake assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic obstructive pulmonary disease, pulmonary, cardiac, cigarettes, e-cigarettes, smokers