Pulmonary Disease, Chronic ObstructiveNCT05510154
COPD E-cigarette Topography Training
A study testing Brief advice, Single Training and Training to Competency in people with Pulmonary Disease, Chronic Obstructive and Tobacco Smoking, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This study is for people with chronic obstructive pulmonary disease (COPD) and who smoke. Investigators are trying to find out if training on e-cigarette use will help smokers switch to e-cigarettes. If training helps, how much training is needed for people to fully switch from cigarettes to e-cigarettes? Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Tobacco Smoking
- What is being tested?
- Brief advice, Single Training and Training to Competency
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 1 Jun 2023
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smokers:
- Diagnosed with COPD
- -≥21 years old
- Speak and understand English
- Smoke on >25 of the last 30 days for the past 3 months
- Willing to switch from cigarettes to the study e-cigarette for the duration of the study
Show all 27Show fewer
- Have tried but failed to quit smoking in the last year
- Unwilling to make a pharmacotherapy-assisted quit attempt in the next 30 days
- Willing to complete six in-person study visits
- Willing to have blood drawn
- Have reliable transportation to attend all in-person assessments
- Have a working phone number
- Plan to remain in the Kansas City area for the full duration of the trial.
- Dual users:
- Diagnosed with COPD
- ≥21 years old
- speak and understand English
- smoke on ≥15 days of the last 30 days for the past 3 months
- willing to switch from cigarettes and their own e-cigarette to the study e-cigarette for the duration of the study
- use an e-cigarette on >15 days of the last 30 days for the past 3 months
- Have tried but failed to quit smoking in the last year
- Unwilling to make a pharmacotherapy-assisted quit attempt in the next 30 days
- Willing to complete six in-person study visits
- Willing to have blood drawn
- Have reliable transportation to attend all in-person assessments
- Have a working phone number
- Plan to remain in the Kansas City area for the full duration of the trial.
Who cannot join
- Smokers:
- Use of tobacco products other than cigarettes including e-cigarettes in the past 30 days
- current use of cessation medications
- pregnant, planning to become pregnant, or breastfeeding
- recent history of cardiovascular or pulmonary events in the past 3 months
- household member current or previously enrolled in the study
Show all 13Show fewer
- weekly use of an e-cigarette over the last 6 months
- Dual Users:
- Use of tobacco products other than cigarettes and e-cigarettes in the past 30 days
- current use of cessation medications
- pregnant, planning to become pregnant, or breastfeeding
- recent history of cardiovascular or pulmonary events in the past 3 months
- household member current or previously enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Missouri, 66160
About this study
Official title: Impact of E-cigarette Training on Puff Patterns, Cigarette Smoking, and Health Outcomes Among Smokers With COPD
This study is for people with chronic obstructive pulmonary disease (COPD) and who smoke. Investigators are trying to find out if training on e-cigarette use will help smokers switch to e-cigarettes. If training helps, how much training is needed for people to fully switch from cigarettes to e-cigarettes?
Read the detailed description
Investigators are doing this study with people who smoke and have chronic obstructive pulmonary disease (COPD). Investigators are trying to find out if e-cigarettes can reduce tobacco-related harm among smokers. Investigators want to know if training on e-cigarette use will help smokers switch to e-cigarettes. If training helps, how much training is needed for people to fully switch from cigarettes to e-cigarettes? This study is an in-lab smoking study and randomized trial. The study takes place at the Main University of Kansas Medical Center (KUMC) campus in Kansas City, Kansas (KS). device. Participants will come to the lab on seven separate days. Between visits, participants will use the study e-cigarette at home. Each time participants come in, participants will fill out surveys about participants tobacco use and use the study product. Investigators will ask participants to switch to the study e-cigarette for 12 weeks during the study.
The study product is an e-cigarette device and is available for sale in the US. Participants will do a few different breathing tests where participants blow into a machine, Investigators will measure participants blood pressure and pulse, and Investigators will do a short walking test. Before three of the visits Investigators will ask participants to not smoke or use an e-cigarette for 12 hours leading up to the visit. During three of the visits, Investigators will ask participants to use the e-cigarette for 30 minutes and take two blood samples. Each visit will last about 2-4 hours. There will be a total of seven visits.
- Being tested
- Brief advice, Single Training, Training to Competency
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief adviceBehavioural
A single, brief advice session on switching to electronic cigarettes.
Single TrainingBehavioural
A single, in-depth training session on switching to electronic cigarettes.
Training to CompetencyBehavioural
Multiple, in-depth training sessions on switching to electronic cigarettes.
| Study group | Role | What they receive |
|---|---|---|
| Brief Advice | Experimental | Brief Advice involves basic e-cigarette education and advice to switch. Receives: Behavioral: Brief advice |
| Single Training | Experimental | Single Training is the same as Brief Advice but includes one session of real-time training on how to puff on the e-cigarette. Receives: Behavioral: Single Training |
| Training to Competency | Experimental | Training to Competency is the same as Single Training but includes three real-time training sessions rather than one. Receives: Behavioral: Training to Competency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in puff duration in seconds from pre- to post-e-cigarette training
Researchers are using a puff topography device to capture real-time electronic cigarette puff and usage patterns. The electronic cigarette is attached to a device during 30-minute sessions where participants use the electronic cigarette as much or as little as they want. Researchers are measuring changes in puff duration in seconds from pre- to post-e-cigarette training/brief advice between smokers who received brief advice versus e-cigarette training (single episode and enhanced e-cigarette training arms combined). Measurements are compared from the first visit to the last visit at week 12.
Measured: 12 weeks
Secondary outcomes (1)
Complete switch to e-cigarette
Proportion of participants who completely switch e-cigarettes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open-label, randomized clinical trial of e-cigarette training and training dose among smokers with COPD. Smokers with COPD (n=45) stratified by e-cigarette use history (naïve vs. current use) will be randomized (1:1:1) to receive 1) brief advice to switch to e-cigarettes, 2) single session e-cigarette training, or 3) enhanced e-cigarette training
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleanor Leavens, University of Kansas Medical Center
- Investigators
- Eleanor Leavens, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510154
- Sponsor's protocol ID
- 147523
- Status last verified
- Jul 2023
- First submitted
- 30 Jun 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leavens ELS, Wagener TL, Lambart L, Mayo MS, Brown L, Ellerbeck EF, Billinger SA, Comfort B, Woodward J, Sear B, Beaman S, Cox LS, Nollen NL. E-cigarette puff topography instruction to enhance switching among COPD patients who smoke. Front Public Health. 2025 Oct 2;13:1664400. doi: 10.3389/fpubh.2025.1664400. eCollection 2025.
PubMed 41112651
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of E-cigarette Training on Puff Patterns, Cigarette Smoking, and Health Outcomes Among Smokers With COPD
- ClinicalTrials.gov ID
- NCT05510154
- Acronym / sponsor ID
- 147523
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 22 Aug 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.
This study is for people with chronic obstructive pulmonary disease (COPD) and who smoke. Investigators are trying to find out if training on e-cigarette use will help smokers switch to e-cigarettes. If training helps, how much training is needed for people to fully switch from cigarettes to e-cigarettes?
Detailed description
Investigators are doing this study with people who smoke and have chronic obstructive pulmonary disease (COPD). Investigators are trying to find out if e-cigarettes can reduce tobacco-related harm among smokers. Investigators want to know if training on e-cigarette use will help smokers switch to e-cigarettes. If training helps, how much training is needed for people to fully switch from cigarettes to e-cigarettes? This study is an in-lab smoking study and randomized trial. The study takes place at the Main University of Kansas Medical Center (KUMC) campus in Kansas City, Kansas (KS). device. Participants will come to the lab on seven separate days. Between visits, participants will use the study e-cigarette at home. Each time participants come in, participants will fill out surveys about participants tobacco use and use the study product. Investigators will ask participants to switch to the study e-cigarette for 12 weeks during the study.
The study product is an e-cigarette device and is available for sale in the US. Participants will do a few different breathing tests where participants blow into a machine, Investigators will measure participants blood pressure and pulse, and Investigators will do a short walking test. Before three of the visits Investigators will ask participants to not smoke or use an e-cigarette for 12 hours leading up to the visit. During three of the visits, Investigators will ask participants to use the e-cigarette for 30 minutes and take two blood samples. Each visit will last about 2-4 hours. There will be a total of seven visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- An open-label, randomized clinical trial of e-cigarette training and training dose among smokers with COPD. Smokers with COPD (n=45) stratified by e-cigarette use history (naïve vs. current use) will be randomized (1:1:1) to receive 1) brief advice to switch to e-cigarettes, 2) single session e-cigarette training, or 3) enhanced e-cigarette training
| Arm | Type | Receives |
|---|---|---|
| Brief Advice | Experimental | Behavioral: Brief adviceBrief Advice involves basic e-cigarette education and advice to switch. |
| Single Training | Experimental | Behavioral: Single TrainingSingle Training is the same as Brief Advice but includes one session of real-time training on how to puff on the e-cigarette. |
| Training to Competency | Experimental | Behavioral: Training to CompetencyTraining to Competency is the same as Single Training but includes three real-time training sessions rather than one. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Smokers:
- Diagnosed with COPD
- -≥21 years old
- Speak and understand English
- Smoke on >25 of the last 30 days for the past 3 months
Key exclusion criteria (13 listed)
- Smokers:
- Use of tobacco products other than cigarettes including e-cigarettes in the past 30 days
- current use of cessation medications
- pregnant, planning to become pregnant, or breastfeeding
- recent history of cardiovascular or pulmonary events in the past 3 months
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 |
|---|---|---|
| Brief adviceA single, brief advice session on switching to electronic cigarettes. | Behavioural | Brief Advice |
| Single TrainingA single, in-depth training session on switching to electronic cigarettes. | Behavioural | Single Training |
| Training to CompetencyMultiple, in-depth training sessions on switching to electronic cigarettes. | Behavioural | Training to Competency |
Primary outcome
Changes in puff duration in seconds from pre- to post-e-cigarette training
Time frame: 12 weeks
Researchers are using a puff topography device to capture real-time electronic cigarette puff and usage patterns. The electronic cigarette is attached to a device during 30-minute sessions where participants use the electronic cigarette as much or as little as they want. Researchers are measuring changes in puff duration in seconds from pre- to post-e-cigarette training/brief advice between smokers who received brief advice versus e-cigarette training (single episode and enhanced e-cigarette training arms combined). Measurements are compared from the first visit to the last visit at week 12.
1 secondary outcome
Complete switch to e-cigarette
Time frame: 12 weeks
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 27 Jul 2023.
- Derived from this study: PubMed 41112651Leavens ELS, Wagener TL, Lambart L, Mayo MS, Brown L, Ellerbeck EF, Billinger SA, Comfort B, Woodward J, Sear B, Beaman S, Cox LS, Nollen NL. E-cigarette puff topography instruction to enhance switching among COPD patients who smoke. Front Public Health. 2025 Oct 2;13:1664400. doi: 10.3389/fpubh.2025.1664400. eCollection 2025.
- 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.
Eleanor Leavens principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief advice, Single Training and Training to Competency in people with Pulmonary Disease, Chronic Obstructive and Tobacco Smoking, run by University of Kansas Medical Center 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 27 inclusion and 13 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 27 Jul 2023. 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.
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?
Changes in puff duration in seconds from pre- to post-e-cigarette training (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05510154, which also lists 1 linked publication.
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 27 Jul 2023; AzTrials last refreshed its copy on 28 Oct 2026.