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NCT Number: NCT06291597

Vaping Adverse Lung and Heart Events Cohort

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.

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Key information

Conditions

Vaping Behavior Electronic Cigarette Use Lung Diseases Lung Injury Respiratory Tract Diseases Smoking Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IUCPQ-UL

Québec, G1V 4G5, Canada

Location status: Recruiting

Location contact

Andréanne Côté, MD, MSc

PRINCIPAL_INVESTIGATOR

Ariane Lechasseur, PhD

CONTACT

[email protected]

418-656-8711 ext. 2652

Mathieu C Morissette, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaping

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariane Lechasseur, PhD

CONTACT

[email protected]

418-656-8711 ext. 2652

Mathieu C Morissette, PhD

CONTACT

[email protected]

418-656-8711 ext. 5394

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Ministere de la Sante et des Services Sociaux

Registry information

Official study title

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

Acronym: VapALERT

Important dates

Study start
2021
Primary completion
2031
Study completion
2032
First posted
Mar 4, 2024
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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