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

Phase 2

Completed

• Conditions: Asthma-COPD Overlap Syndrome; Chronic Obstructive Pulmonary Disease; Emphysema; Chronic Bronchitis
• Interventions: Other: E-Cigarette; Behavioral: Financial Incentives

• Registration Number: NCT05610514
• Lead Sponsor: University of Vermont

Brief Summary

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

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 Timeline

• Study Start: 2022-04-28
• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-09
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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Exclusion Criteria

• Patients who are medically unstable (unstable symptoms, changes in medications or hospitalizations within last 3 months)
• Inability to conduct in-home measurements.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
E-Cigarette	Financial Incentives	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.
E-Cigarette	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline FEV1/FVC Ratio at 2 weeks	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
Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19)	Intake assessment	Airway impedence in the lungs as measured by oscillometry
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 4 weeks	Assessment completed 4 weeks after intake assessment	Airway impedence in the lungs as measured by oscillometry
Baseline FEV1/FVC Ratio	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
Change from Baseline FEV1/FVC Ratio at 4 weeks	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
Baseline Lung Reactance at 5Hz (X5)	Intake assessment	Measurement of the ability of the lung to store energy, as measured by oscillometry
Baseline Oxygen Saturation (SpO2)	Intake assessment	Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Change from Baseline Oxygen Saturation (SpO2) at 4 weeks	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
Change from Baseline FEV1/FVC Ratio each day	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
Change from Baseline Oxygen Saturation (SpO2) at 2 weeks	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
Baseline Fractional Exhaled Nitric Oxide (FeNO)	Intake assessment	Amount of nitric oxide in the breath
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks	Assessment completed 2 weeks after intake assessment	Amount of nitric oxide in the breath
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks	Assessment completed 2 weeks after intake assessment	Airway impedence in the lungs as measured by oscillometry
Change from Baseline Oxygen Saturation (SpO2) each day	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
Baseline St. George's Respiratory Questionnaire for COPD Patients Score	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
Change from Baseline Lung Reactance at 5Hz (X5) at 2 weeks	Assessment completed 2 weeks after intake assessment	Measurement of the ability of the lung to store energy, as measured by oscillometry
Change from Baseline Lung Reactance at 5Hz (X5) at 4 weeks	Assessment completed 4 weeks after intake assessment	Measurement of the ability of the lung to store energy, as measured by oscillometry
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks	Assessment completed 4 weeks after intake assessment	Amount of nitric oxide in the breath
Baseline COPD Assessment Test Score	Intake assessment	Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
Change from Baseline COPD Assessment Test Score at 2 weeks	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
Change from Baseline COPD Assessment Test Score at 4 weeks	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
Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 2 weeks	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
Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 4 weeks	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 Outcome Measures

Name	Time	Method
Baseline Heart Rate	Intake assessment	Number of time the heart beats per minute
Change From Baseline Heart Rate at 4 weeks	Assessment completed 4 weeks after intake assessment	Number of time the heart beats per minute
Baseline Blood Pressure	Intake assessment	Force exerted by blood against the walls of the arteries
Change from Baseline Heart Rate each day	Daily through study completion, an average of 4 weeks	Number of time the heart beats per minute
Change From Baseline Heart Rate at 2 weeks	Assessment completed 2 weeks after intake assessment	Number of time the heart beats per minute
Change from Baseline Blood Pressure at 4 weeks	Assessment completed 4 weeks after intake assessment	Force exerted by blood against the walls of the arteries
Change from Baseline Blood Pressure each day	Daily through study completion, an average of 4 weeks	Force exerted by blood against the walls of the arteries
Change from Baseline Blood Pressure at 2 weeks	Assessment completed 2 weeks after intake assessment	Force exerted by blood against the walls of the arteries

Trial Locations

Locations (1)

Vermont Center on Behavior and Health; 🇺🇸 Burlington, Vermont, United States