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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Emphysema; Chronic Bronchitis; Asthma-COPD Overlap Syndrome
• Intervention / Treatment: Other: E-Cigarette; Behavioral: Financial Incentives

Detailed Description

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
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Vermont Center on Behavior and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Combustible Cigarette; Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks.
Experimental: E-Cigarette; 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; Altering the availability of e-cigarettes; Behavioral: Financial Incentives; Altering the availability of financial incentives for abstaining from combustible cigarettes

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Carbon Monoxide (CO)	Amount of carbon monoxide in the breath	Intake assessment
Change from Baseline Carbon Monoxide (CO) each day	Amount of carbon monoxide in the breath	Daily through study completion, an average of 4 weeks
Change from Baseline Carbon Monoxide (CO) at 2 weeks	Amount of carbon monoxide in the breath	Assessment completed 2 weeks after intake assessment
Change from Baseline Carbon Monoxide (CO) at 4 weeks	Amount of carbon monoxide in the breath	Assessment completed 4 weeks after intake assessment
Baseline Tobacco Use Questionnaire	Assess tobacco use history	Intake assessment
Baseline Fagerstrom Test of Nicotine Dependence (FTND)	Survey assessing addiction to nicotine	Intake assessment
Baseline Wisconsin Inventory of Smoking Dependence Motives - Brief (WISDM-Brief)	Survey assessing smoking dependence	Intake assessment
Baseline Minnesota Tobacco Withdrawal Scale (MNWS)	Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome	Intake assessment
Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 2 weeks	Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome	Assessment completed 2 weeks after intake assessment
Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 4 weeks	Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome	Assessment completed 4 weeks after intake assessment
Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief)	Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke	Intake assessment
Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 2 weeks	Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke	Assessment completed 2 weeks after intake assessment
Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 4 weeks	Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke	Assessment completed 4 weeks after intake assessment
Daily Tobacco Use Questionnaire	Measure tobacco use (cigarettes, e-cigarettes, smokeless tobacco) on a daily basis;	Daily during each two-week arm of the study
Health Changes Questionnaire at 2 week assessment	Assesses how health has changed since previous visit; 4 yes/no questions about whether there have been any changes in physical/mental health, changes in medications, access to medical care, or changes in normal routine in the last 24 hours; 1 question rating overall health on a scale of 1 to 10 with 10 being the best	Assessment completed 2 weeks after intake assessment
Health Changes Questionnaire at 4 week assessment	Assesses how health has changed since previous visit; 4 yes/no questions about whether there have been any changes in physical/mental health, changes in medications, access to medical care, or changes in normal routine in the last 24 hours; 1 question rating overall health on a scale of 1 to 10 with 10 being the best	Assessment completed 4 weeks after intake assessment

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Diann E Gaalema, PhD, University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cardiac; smokers; e-cigarettes; cigarettes; pulmonary; chronic obstructive pulmonary disease
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Disease Attributes; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis; Bronchitis, Chronic; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
• Other Study ID Numbers: STUDY00000511; U54DA036114-07 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No