Back to resultsPulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
Primary Purpose
Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
E-Cigarette
Financial Incentives
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, pulmonary, cardiac, cigarettes, e-cigarettes, smokers
Eligibility Criteria
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.
Sites / Locations
- Vermont Center on Behavior and HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Combustible Cigarette
E-Cigarette
Arm Description
Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks.
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.
Outcomes
Primary Outcome Measures
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
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
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
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
Baseline Lung Reactance at 5Hz (X5)
Measurement of the ability of the lung to store energy, as measured by oscillometry
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
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
Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19)
Airway impedence in the lungs as measured by oscillometry
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks
Airway impedence in the lungs as measured by oscillometry
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 4 weeks
Airway impedence in the lungs as measured by oscillometry
Baseline Oxygen Saturation (SpO2)
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) each day
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 2 weeks
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
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)
Amount of nitric oxide in the breath
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks
Amount of nitric oxide in the breath
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks
Amount of nitric oxide in the breath
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
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
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
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
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
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
Secondary Outcome Measures
Baseline Blood Pressure
Force exerted by blood against the walls of the arteries
Change from Baseline Blood Pressure each day
Force exerted by blood against the walls of the arteries
Change from Baseline Blood Pressure at 2 weeks
Force exerted by blood against the walls of the arteries
Change from Baseline Blood Pressure at 4 weeks
Force exerted by blood against the walls of the arteries
Baseline Heart Rate
Number of time the heart beats per minute
Change from Baseline Heart Rate each day
Number of time the heart beats per minute
Change From Baseline Heart Rate at 2 weeks
Number of time the heart beats per minute
Change From Baseline Heart Rate at 4 weeks
Number of time the heart beats per minute
Full Information
NCT ID
NCT05610514
First Posted
October 28, 2022
Last Updated
November 3, 2022
Sponsor
University of Vermont
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05610514
Brief Title
Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
Official Title
Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Asthma-COPD Overlap Syndrome
Keywords
chronic obstructive pulmonary disease, pulmonary, cardiac, cigarettes, e-cigarettes, smokers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combustible Cigarette
Arm Type
No Intervention
Arm Description
Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks.
Arm Title
E-Cigarette
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
E-Cigarette
Intervention Description
Altering the availability of e-cigarettes
Intervention Type
Behavioral
Intervention Name(s)
Financial Incentives
Intervention Description
Altering the availability of financial incentives for abstaining from combustible cigarettes
Primary Outcome Measure Information:
Title
Baseline FEV1/FVC Ratio
Description
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
Title
Change from Baseline FEV1/FVC Ratio each day
Description
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
Title
Change from Baseline FEV1/FVC Ratio at 2 weeks
Description
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
Title
Change from Baseline FEV1/FVC Ratio at 4 weeks
Description
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
Title
Baseline Lung Reactance at 5Hz (X5)
Description
Measurement of the ability of the lung to store energy, as measured by oscillometry
Time Frame
Intake assessment
Title
Change from Baseline Lung Reactance at 5Hz (X5) at 2 weeks
Description
Measurement of the ability of the lung to store energy, as measured by oscillometry
Time Frame
Assessment completed 2 weeks after intake assessment
Title
Change from Baseline Lung Reactance at 5Hz (X5) at 4 weeks
Description
Measurement of the ability of the lung to store energy, as measured by oscillometry
Time Frame
Assessment completed 4 weeks after intake assessment
Title
Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19)
Description
Airway impedence in the lungs as measured by oscillometry
Time Frame
Intake assessment
Title
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks
Description
Airway impedence in the lungs as measured by oscillometry
Time Frame
Assessment completed 2 weeks after intake assessment
Title
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 4 weeks
Description
Airway impedence in the lungs as measured by oscillometry
Time Frame
Assessment completed 4 weeks after intake assessment
Title
Baseline Oxygen Saturation (SpO2)
Description
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Time Frame
Intake assessment
Title
Change from Baseline Oxygen Saturation (SpO2) each day
Description
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
Title
Change from Baseline Oxygen Saturation (SpO2) at 2 weeks
Description
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
Title
Change from Baseline Oxygen Saturation (SpO2) at 4 weeks
Description
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
Title
Baseline Fractional Exhaled Nitric Oxide (FeNO)
Description
Amount of nitric oxide in the breath
Time Frame
Intake assessment
Title
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks
Description
Amount of nitric oxide in the breath
Time Frame
Assessment completed 2 weeks after intake assessment
Title
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks
Description
Amount of nitric oxide in the breath
Time Frame
Assessment completed 4 weeks after intake assessment
Title
Baseline COPD Assessment Test Score
Description
Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
Time Frame
Intake assessment
Title
Change from Baseline COPD Assessment Test Score at 2 weeks
Description
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
Title
Change from Baseline COPD Assessment Test Score at 4 weeks
Description
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
Title
Baseline St. George's Respiratory Questionnaire for COPD Patients Score
Description
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
Title
Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 2 weeks
Description
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
Title
Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 4 weeks
Description
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
Secondary Outcome Measure Information:
Title
Baseline Blood Pressure
Description
Force exerted by blood against the walls of the arteries
Time Frame
Intake assessment
Title
Change from Baseline Blood Pressure each day
Description
Force exerted by blood against the walls of the arteries
Time Frame
Daily through study completion, an average of 4 weeks
Title
Change from Baseline Blood Pressure at 2 weeks
Description
Force exerted by blood against the walls of the arteries
Time Frame
Assessment completed 2 weeks after intake assessment
Title
Change from Baseline Blood Pressure at 4 weeks
Description
Force exerted by blood against the walls of the arteries
Time Frame
Assessment completed 4 weeks after intake assessment
Title
Baseline Heart Rate
Description
Number of time the heart beats per minute
Time Frame
Intake assessment
Title
Change from Baseline Heart Rate each day
Description
Number of time the heart beats per minute
Time Frame
Daily through study completion, an average of 4 weeks
Title
Change From Baseline Heart Rate at 2 weeks
Description
Number of time the heart beats per minute
Time Frame
Assessment completed 2 weeks after intake assessment
Title
Change From Baseline Heart Rate at 4 weeks
Description
Number of time the heart beats per minute
Time Frame
Assessment completed 4 weeks after intake assessment
Other Pre-specified Outcome Measures:
Title
Baseline Carbon Monoxide (CO)
Description
Amount of carbon monoxide in the breath
Time Frame
Intake assessment
Title
Change from Baseline Carbon Monoxide (CO) each day
Description
Amount of carbon monoxide in the breath
Time Frame
Daily through study completion, an average of 4 weeks
Title
Change from Baseline Carbon Monoxide (CO) at 2 weeks
Description
Amount of carbon monoxide in the breath
Time Frame
Assessment completed 2 weeks after intake assessment
Title
Change from Baseline Carbon Monoxide (CO) at 4 weeks
Description
Amount of carbon monoxide in the breath
Time Frame
Assessment completed 4 weeks after intake assessment
Title
Baseline Tobacco Use Questionnaire
Description
Assess tobacco use history
Time Frame
Intake assessment
Title
Baseline Fagerstrom Test of Nicotine Dependence (FTND)
Description
Survey assessing addiction to nicotine
Time Frame
Intake assessment
Title
Baseline Wisconsin Inventory of Smoking Dependence Motives - Brief (WISDM-Brief)
Description
Survey assessing smoking dependence
Time Frame
Intake assessment
Title
Baseline Minnesota Tobacco Withdrawal Scale (MNWS)
Description
Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome
Time Frame
Intake assessment
Title
Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 2 weeks
Description
Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome
Time Frame
Assessment completed 2 weeks after intake assessment
Title
Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 4 weeks
Description
Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome
Time Frame
Assessment completed 4 weeks after intake assessment
Title
Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief)
Description
Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke
Time Frame
Intake assessment
Title
Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 2 weeks
Description
Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke
Time Frame
Assessment completed 2 weeks after intake assessment
Title
Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 4 weeks
Description
Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke
Time Frame
Assessment completed 4 weeks after intake assessment
Title
Daily Tobacco Use Questionnaire
Description
Measure tobacco use (cigarettes, e-cigarettes, smokeless tobacco) on a daily basis;
Time Frame
Daily during each two-week arm of the study
Title
Health Changes Questionnaire at 2 week assessment
Description
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
Time Frame
Assessment completed 2 weeks after intake assessment
Title
Health Changes Questionnaire at 4 week assessment
Description
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
Time Frame
Assessment completed 4 weeks after intake assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian R Katz, PhD
Phone
8025511798
Email
Brian.Katz@uvm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon O'connor
Phone
8025511798
Email
shannon.oconnor@uvm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diann E Gaalema, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vermont Center on Behavior and Health
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian R Katz, PhD
Phone
802-551-1798
Email
brian.katz@uvm.edu
First Name & Middle Initial & Last Name & Degree
Shannon O'connor
Phone
8025511798
Email
shannon.oconnor@uvm.edu
First Name & Middle Initial & Last Name & Degree
Diann E Gaalema, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
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