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Completed

NCT Number: NCT05610514

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Asthma Asthma-COPD Overlap Syndrome Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome Behavior Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Bronchitis Chronic Disease Disease Attributes Emphysema Hypersensitivity Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Smoking Vaping

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vermont Center on Behavior and Health

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E-Cigarette

Other

Altering the availability of e-cigarettes

Financial Incentives

Behavioral

Altering the availability of financial incentives for abstaining from combustible cigarettes

Primary outcomes

  1. Baseline FEV1/FVC Ratio

    Time frame: Intake assessment

    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

  2. Change from Baseline FEV1/FVC Ratio each day

    Time frame: Daily through study completion, an average of 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

  3. Change from Baseline FEV1/FVC Ratio at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    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

  4. Change from Baseline FEV1/FVC Ratio at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    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

  5. Baseline Lung Reactance at 5Hz (X5)

    Time frame: Intake assessment

    Measurement of the ability of the lung to store energy, as measured by oscillometry

  6. Change from Baseline Lung Reactance at 5Hz (X5) at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    Measurement of the ability of the lung to store energy, as measured by oscillometry

  7. Change from Baseline Lung Reactance at 5Hz (X5) at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    Measurement of the ability of the lung to store energy, as measured by oscillometry

  8. Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19)

    Time frame: Intake assessment

    Airway impedence in the lungs as measured by oscillometry

  9. Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    Airway impedence in the lungs as measured by oscillometry

  10. Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    Airway impedence in the lungs as measured by oscillometry

  11. Baseline Oxygen Saturation (SpO2)

    Time frame: Intake assessment

    Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry

  12. Change from Baseline Oxygen Saturation (SpO2) each day

    Time frame: Daily through study completion, an average of 4 weeks

    Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry

  13. Change from Baseline Oxygen Saturation (SpO2) at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry

  14. Change from Baseline Oxygen Saturation (SpO2) at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry

  15. Baseline Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: Intake assessment

    Amount of nitric oxide in the breath

  16. Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    Amount of nitric oxide in the breath

  17. Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    Amount of nitric oxide in the breath

  18. Baseline COPD Assessment Test Score

    Time frame: Intake assessment

    Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome

  19. Change from Baseline COPD Assessment Test Score at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome

  20. Change from Baseline COPD Assessment Test Score at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome

  21. Baseline St. George's Respiratory Questionnaire for COPD Patients Score

    Time frame: Intake assessment

    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

  22. Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    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

  23. Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    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

Secondary outcomes

  1. Baseline Blood Pressure

    Time frame: Intake assessment

    Force exerted by blood against the walls of the arteries

  2. Change from Baseline Blood Pressure each day

    Time frame: Daily through study completion, an average of 4 weeks

    Force exerted by blood against the walls of the arteries

  3. Change from Baseline Blood Pressure at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    Force exerted by blood against the walls of the arteries

  4. Change from Baseline Blood Pressure at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    Force exerted by blood against the walls of the arteries

  5. Baseline Heart Rate

    Time frame: Intake assessment

    Number of time the heart beats per minute

  6. Change from Baseline Heart Rate each day

    Time frame: Daily through study completion, an average of 4 weeks

    Number of time the heart beats per minute

  7. Change From Baseline Heart Rate at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    Number of time the heart beats per minute

  8. Change From Baseline Heart Rate at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    Number of time the heart beats per minute

Other outcomes

  1. Baseline Carbon Monoxide (CO)

    Time frame: Intake assessment

    Amount of carbon monoxide in the breath

  2. Change from Baseline Carbon Monoxide (CO) each day

    Time frame: Daily through study completion, an average of 4 weeks

    Amount of carbon monoxide in the breath

  3. Change from Baseline Carbon Monoxide (CO) at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    Amount of carbon monoxide in the breath

  4. Change from Baseline Carbon Monoxide (CO) at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    Amount of carbon monoxide in the breath

  5. Baseline Tobacco Use Questionnaire

    Time frame: Intake assessment

    Assess tobacco use history

  6. Baseline Fagerstrom Test of Nicotine Dependence (FTND)

    Time frame: Intake assessment

    Survey assessing addiction to nicotine

  7. Baseline Wisconsin Inventory of Smoking Dependence Motives - Brief (WISDM-Brief)

    Time frame: Intake assessment

    Survey assessing smoking dependence

  8. Baseline Minnesota Tobacco Withdrawal Scale (MNWS)

    Time frame: Intake assessment

    Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome

  9. Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome

  10. Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome

  11. Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief)

    Time frame: Intake assessment

    Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke

  12. Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 2 weeks

    Time frame: Assessment completed 2 weeks after intake assessment

    Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke

  13. Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 4 weeks

    Time frame: Assessment completed 4 weeks after intake assessment

    Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke

  14. Daily Tobacco Use Questionnaire

    Time frame: Daily during each two-week arm of the study

    Measure tobacco use (cigarettes, e-cigarettes, smokeless tobacco) on a daily basis;

  15. Health Changes Questionnaire at 2 week assessment

    Time frame: Assessment completed 2 weeks after intake 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

  16. Health Changes Questionnaire at 4 week assessment

    Time frame: Assessment completed 4 weeks after intake 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

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2022
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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