VapingVapALERTNCT06291597
Vaping Adverse Lung and Heart Events Cohort
An observational study of Vaping and Electronic Cigarette Use, run by Laval University at 1 site in Canada.
Trial summary
This prospective study assesses the pulmonary and cardiovascular effets of vaping in adult electronic cigarette users with biannual visits and a 5-year follow-up. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaping, Electronic Cigarette Use
- What is being tested?
- Vaping
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 14 Oct 2021to Jun 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We seek to recruit 250 volunteers from the community with twice-a-year visits for a 5-year follow-up. We will recruit healthy volunteers as well as volunteers who have been previously diagnosed with chronic illness.
Who may be able to join
- Age 18 years or older
- Daily electronic cigarette user
- No respiratory infection in the 4 weeks before a visit
Who cannot join
- Women who are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
IUCPQ-UL
Québec, G1V 4G5
Ariane Lechasseur, PhD, 418-656-8711 ext. 2652, ariane.lechasseur@criucpq.ulaval.ca
Mathieu C Morissette, PhD
About this study
Official title: VapALERT: A Prospective, Exploratory and Adaptive Cohort Study to Identify Symptomatic and Asymptomatic Pulmonary and Cardiovascular Effects of Vaping
This prospective study assesses the pulmonary and cardiovascular effets of vaping in adult electronic cigarette users with biannual visits and a 5-year follow-up.
Read the detailed description
Daily vaping device users will be recruited in the Quebec City metropolitan area. Subjects will be asked to perform pulmonary function tests (spirometry, oscillometry, plethysmography, methacholine provocation) every 6 months for a 5-year follow up. Subjects will also answer a questionnaire assessing their vaping, tobacco and cannabis smoking habits, as well as their perceived respiratory symptoms. Blood draws and sputum inductions will be performed for cell counts and to measure inflammation markers.
- Conditions
- Vaping, Electronic Cigarette Use
- Being tested
- Vaping
- Keywords
- Vaping, Vape, Electronic cigarette, Electronic and vaping acute lung injury, EVALI
- Medical subject headings
- Vaping, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VapingOther
Participants use their vaping products at their own discretion and their intake is monitored via questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Daily electronic cigarette users | Participants must use their vaping device everyday at time of enrollment. Receives: Other: Vaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who vape daily with impaired lung volumes.
Participants will perform plethysmography assessments to measure changes in lung volumes. Data will be expressed as a percentage of predicted values.
Measured: Every 6 months for 5 years
Number of participants who vape daily with impaired lung diffusion capacity.
Participants will perform diffusion capacity of the lung for carbon monoxide (DLCO) measures to assess changes in lung diffusion capacity. Data will be expressed as a percentage of predicted values.
Measured: Every 6 months for 5 years
Number of participants who vape daily with impaired spirometry.
Participants will perform spirometry tests measures to assess changes in forced expiratory lung volumes. Data will be expressed as a percentage of predicted values.
Measured: Every 6 months for 5 years
Number of participants who vape daily with airway hyperresponsiveness.
Participants will perform methacholine provocation challenge measures to assess changes in airway hyperresponsiveness. Data will be expressed as the methacholine concentration inducing a fall of 20% of forced expiratory volume in the first second assessed (PC20).
Measured: Every 6 months for 5 years
Number of participants who vape daily with changes in blood cell count.
Participants will perform a blood draw to assess blood cell count. Data will be expressed as a percentage of eosinophils, neutrophils, macrophages and lymphocytes of the total cell count.
Measured: Every 6 months for 5 years
Number of participants who vape daily with changes in sputum cell count.
Participants will perform sputum inductions to assess cell count in the sputum. Data will be expressed as a percentage of eosinophils, neutrophils, macrophages and lymphocytes of the total cell count.
Measured: Every 6 months for 5 years
Vaping, tobacco and cannabis smoking habits of participants.
Participants will complete questionnaires assessing their vaping habits, tobacco smoking and cannabis smoking history.
Measured: Every 3 months for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start14 Oct 2021
- Primary completionDec 2031 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VapingStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux
- Responsible party
- Sponsor
- Investigators
- Mathieu C Morissette, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291597
- Sponsor's protocol ID
- 22071
- Acronym
- VapALERT
- Status last verified
- Feb 2024
- First submitted
- 7 Oct 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VapALERT: A Prospective, Exploratory and Adaptive Cohort Study to Identify Symptomatic and Asymptomatic Pulmonary and Cardiovascular Effects of Vaping
- ClinicalTrials.gov ID
- NCT06291597
- Acronym / sponsor ID
- VapALERT / 22071
- Conditions
- Vaping, Electronic Cigarette Use
- Keywords
- Vaping, Vape, Electronic cigarette, Electronic and vaping acute lung injury, EVALI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 4 Mar 2024 (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 prospective study assesses the pulmonary and cardiovascular effets of vaping in adult electronic cigarette users with biannual visits and a 5-year follow-up.
Detailed description
Daily vaping device users will be recruited in the Quebec City metropolitan area. Subjects will be asked to perform pulmonary function tests (spirometry, oscillometry, plethysmography, methacholine provocation) every 6 months for a 5-year follow up. Subjects will also answer a questionnaire assessing their vaping, tobacco and cannabis smoking habits, as well as their perceived respiratory symptoms. Blood draws and sputum inductions will be performed for cell counts and to measure inflammation markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily electronic cigarette users | – | Other: VapingParticipants must use their vaping device everyday at time of enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We seek to recruit 250 volunteers from the community with twice-a-year visits for a 5-year follow-up. We will recruit healthy volunteers as well as volunteers who have been previously diagnosed with chronic illness.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Daily electronic cigarette user
- No respiratory infection in the 4 weeks before a visit
Key exclusion criteria (1 listed)
- Women who are pregnant or breast-feeding.
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 |
|---|---|---|
| VapingParticipants use their vaping products at their own discretion and their intake is monitored via questionnaires. | Other | Daily electronic cigarette users |
Primary outcome
Number of participants who vape daily with impaired lung volumes.
Time frame: Every 6 months for 5 years
Participants will perform plethysmography assessments to measure changes in lung volumes. Data will be expressed as a percentage of predicted values.
Number of participants who vape daily with impaired lung diffusion capacity.
Time frame: Every 6 months for 5 years
Participants will perform diffusion capacity of the lung for carbon monoxide (DLCO) measures to assess changes in lung diffusion capacity. Data will be expressed as a percentage of predicted values.
Number of participants who vape daily with impaired spirometry.
Time frame: Every 6 months for 5 years
Participants will perform spirometry tests measures to assess changes in forced expiratory lung volumes. Data will be expressed as a percentage of predicted values.
Number of participants who vape daily with airway hyperresponsiveness.
Time frame: Every 6 months for 5 years
Participants will perform methacholine provocation challenge measures to assess changes in airway hyperresponsiveness. Data will be expressed as the methacholine concentration inducing a fall of 20% of forced expiratory volume in the first second assessed (PC20).
Number of participants who vape daily with changes in blood cell count.
Time frame: Every 6 months for 5 years
Participants will perform a blood draw to assess blood cell count. Data will be expressed as a percentage of eosinophils, neutrophils, macrophages and lymphocytes of the total cell count.
Number of participants who vape daily with changes in sputum cell count.
Time frame: Every 6 months for 5 years
Participants will perform sputum inductions to assess cell count in the sputum. Data will be expressed as a percentage of eosinophils, neutrophils, macrophages and lymphocytes of the total cell count.
Vaping, tobacco and cannabis smoking habits of participants.
Time frame: Every 3 months for 5 years
Participants will complete questionnaires assessing their vaping habits, tobacco smoking and cannabis smoking history.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 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.
Mathieu C Morissette, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaping and Electronic Cigarette Use, run by Laval University at 1 site in Canada.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Mar 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariane Lechasseur, PhD (418-656-8711 ext. 2652, ariane.lechasseur@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who vape daily with impaired lung volumes. (time frame: Every 6 months for 5 years). The study lists 7 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 4 Mar 2024.