VapALERT: A Prospective, Exploratory and Adaptive Cohort Study to Identify Symptomatic and Asymptomatic Pulmonary and Cardiovascular Effects of Vaping
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Laval University
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Number of participants who vape daily with impaired lung volumes.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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 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.
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.
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.
Secondary Outcomes
No secondary outcomes reported