Chronic Obstructive Pulmonary DiseasePhase 2NCT05610514
Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
A Phase 2 study testing E-Cigarette and Financial Incentives in people with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema
- What is being tested?
- E-Cigarette and Financial Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2022to 1 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are medically unstable (unstable symptoms, changes in medications or hospitalizations within last 3 months)
- Inability to conduct in-home measurements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vermont Center on Behavior and Health
Burlington, Vermont, 05401
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Asthma-COPD Overlap Syndrome
- Being tested
- E-Cigarette, Financial Incentives
- Keywords
- chronic obstructive pulmonary disease, pulmonary, cardiac, cigarettes, e-cigarettes, smokers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema, Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-CigaretteOther
Altering the availability of e-cigarettes
Financial IncentivesBehavioural
Altering the availability of financial incentives for abstaining from combustible cigarettes
| Study group | Role | What they receive |
|---|---|---|
| Combustible Cigarette | No intervention | Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks. |
| E-Cigarette | Experimental | 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. Receives: Other: E-Cigarette; Behavioral: Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessment completed 4 weeks after intake assessment
Baseline Fractional Exhaled Nitric Oxide (FeNO)
Amount of nitric oxide in the breath
Measured: Intake assessment
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks
Amount of nitric oxide in the breath
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessment completed 4 weeks after intake assessment
Secondary outcomes (8)
Baseline Blood Pressure
Force exerted by blood against the walls of the arteries
Measured: Intake assessment
Change from Baseline Blood Pressure each day
Force exerted by blood against the walls of the arteries
Measured: 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
Measured: 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
Measured: Assessment completed 4 weeks after intake assessment
Baseline Heart Rate
Number of time the heart beats per minute
Measured: Intake assessment
Change from Baseline Heart Rate each day
Number of time the heart beats per minute
Measured: 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
Measured: Assessment completed 2 weeks after intake assessment
Change From Baseline Heart Rate at 4 weeks
Number of time the heart beats per minute
Measured: Assessment completed 4 weeks after intake assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start28 Apr 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Diann Gaalema, University of Vermont
- Investigators
- Diann E Gaalema, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610514
- Sponsor's protocol ID
- STUDY00000511
- Other IDs
- U54DA036114-07
- Status last verified
- Feb 2024
- First submitted
- 28 Oct 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
- ClinicalTrials.gov ID
- NCT05610514
- Acronym / sponsor ID
- STUDY00000511
- Conditions
- Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Asthma-COPD Overlap Syndrome
- Keywords
- chronic obstructive pulmonary disease, pulmonary, cardiac, cigarettes, e-cigarettes, smokers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combustible Cigarette | No intervention | –Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks. |
| E-Cigarette | Experimental | Other: E-Cigarette, Behavioral: Financial IncentivesParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are medically unstable (unstable symptoms, changes in medications or hospitalizations within last 3 months)
- Inability to conduct in-home measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-CigaretteAltering the availability of e-cigarettes | Other | E-Cigarette |
| Financial IncentivesAltering the availability of financial incentives for abstaining from combustible cigarettes | Behavioural | E-Cigarette |
Primary outcome
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
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
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
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
Baseline Lung Reactance at 5Hz (X5)
Time frame: 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 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
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
Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19)
Time frame: Intake assessment
Airway impedence in the lungs as measured by oscillometry
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
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
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
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
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
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
Baseline Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Intake assessment
Amount of nitric oxide in the breath
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
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
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
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
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
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
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
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
8 secondary outcomes
Baseline Blood Pressure
Time frame: Intake assessment
Change from Baseline Blood Pressure each day
Time frame: Daily through study completion, an average of 4 weeks
Change from Baseline Blood Pressure at 2 weeks
Time frame: Assessment completed 2 weeks after intake assessment
Change from Baseline Blood Pressure at 4 weeks
Time frame: Assessment completed 4 weeks after intake assessment
Baseline Heart Rate
Time frame: Intake assessment
Change from Baseline Heart Rate each day
Time frame: Daily through study completion, an average of 4 weeks
Change From Baseline Heart Rate at 2 weeks
Time frame: Assessment completed 2 weeks after intake assessment
Change From Baseline Heart Rate at 4 weeks
Time frame: Assessment completed 4 weeks after intake assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diann E Gaalema, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E-Cigarette and Financial Incentives in people with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline FEV1/FVC Ratio (time frame: Intake assessment). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.