A Phase 2 interventional study of E-Cigarette and Financial Incentives in Chronic Obstructive Pulmonary Disease, Chronic Bronchitis and Emphysema, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by University of Vermont · Phase 2, Interventional, and Basic science
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.
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.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's enrollment of 21 is below the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.
Browse Bronchitis, Chronic studies →University of Vermont is the lead sponsor of 221 studies on the registry; 27 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
Compared within Bronchitis, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pulmonary Disease, Chronic Obstructive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: E-Cigarette · Behavioral: Financial Incentives
Altering the availability of e-cigarettes
Altering the availability of financial incentives for abstaining from combustible cigarettes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Fractional Exhaled Nitric Oxide (FeNO)
Amount of nitric oxide in the breath
Time frame: Intake assessment
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks
Amount of nitric oxide in the breath
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Blood Pressure
Force exerted by blood against the walls of the arteries
Time frame: Intake assessment
Change from Baseline Blood Pressure each day
Force exerted by blood against the walls of the arteries
Time frame: 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
Time frame: 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
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Heart Rate
Number of time the heart beats per minute
Time frame: Intake assessment
Change from Baseline Heart Rate each day
Number of time the heart beats per minute
Time frame: 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
Time frame: Assessment completed 2 weeks after intake assessment
Change From Baseline Heart Rate at 4 weeks
Number of time the heart beats per minute
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Carbon Monoxide (CO)
Amount of carbon monoxide in the breath
Time frame: Intake assessment
Change from Baseline Carbon Monoxide (CO) each day
Amount of carbon monoxide in the breath
Time frame: 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
Time frame: Assessment completed 2 weeks after intake assessment
Change from Baseline Carbon Monoxide (CO) at 4 weeks
Amount of carbon monoxide in the breath
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Tobacco Use Questionnaire
Assess tobacco use history
Time frame: Intake assessment
Baseline Fagerstrom Test of Nicotine Dependence (FTND)
Survey assessing addiction to nicotine
Time frame: Intake assessment
Baseline Wisconsin Inventory of Smoking Dependence Motives - Brief (WISDM-Brief)
Survey assessing smoking dependence
Time frame: Intake assessment
Baseline Minnesota Tobacco Withdrawal Scale (MNWS)
Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessment completed 4 weeks after intake assessment
Daily Tobacco Use Questionnaire
Measure tobacco use (cigarettes, e-cigarettes, smokeless tobacco) on a daily basis;
Time frame: 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
Time frame: 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
Time frame: Assessment completed 4 weeks after intake assessment
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2022 to primary completion in Dec 2023, 19 months.
Of 14 phase 2 interventional studies under Bronchitis, Chronic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 20. This study's 19 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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