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Vaping Adverse Lung and Heart Events Cohort

VapALERT: A Prospective, Exploratory and Adaptive Cohort Study to Identify Symptomatic and Asymptomatic Pulmonary and Cardiovascular Effects of Vaping

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06291597
Acronym
VapALERT
Enrollment
250
Registered
2024-03-04
Start date
2021-10-14
Completion date
2032-06-30
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electronic Cigarette Use, Vaping

Keywords

Vaping, Vape, Electronic cigarette, Electronic and vaping acute lung injury, EVALI

Brief 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.

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.

Interventions

OTHERVaping

Participants use their vaping products at their own discretion and their intake is monitored via questionnaires.

Sponsors

Ministere de la Sante et des Services Sociaux
CollaboratorOTHER
Laval University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 18 years or older * Daily electronic cigarette user * No respiratory infection in the 4 weeks before a visit

Exclusion criteria

* Women who are pregnant or breast-feeding.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who vape daily with impaired lung volumes.Every 6 months for 5 yearsParticipants 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.Every 6 months for 5 yearsParticipants 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.Every 6 months for 5 yearsParticipants 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.Every 6 months for 5 yearsParticipants 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.Every 6 months for 5 yearsParticipants 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.Every 6 months for 5 yearsParticipants 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.Every 3 months for 5 yearsParticipants will complete questionnaires assessing their vaping habits, tobacco smoking and cannabis smoking history.

Countries

Canada

Contacts

Primary ContactAriane Lechasseur, PhD
ariane.lechasseur@criucpq.ulaval.ca418-656-8711
Backup ContactMathieu C Morissette, PhD
mathieu.morissette@criucpq.ulaval.ca418-656-8711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026