Vaping Adverse Lung and Heart Events Cohort (VapALERT)

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.

Study Overview

• Status: Recruiting
• Conditions: Electronic Cigarette Use; Vaping
• Intervention / Treatment: Other: Vaping

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Ariane Lechasseur, PhD; Phone Number: 2652 418-656-8711; Email: ariane.lechasseur@criucpq.ulaval.ca
• Study Contact Backup: Name: Mathieu C Morissette, PhD; Phone Number: 5394 418-656-8711; Email: mathieu.morissette@criucpq.ulaval.ca

Study Locations

• Canada
  • Québec, Canada, G1V 4G5
    • Recruiting
    • IUCPQ-UL
    • Contact: Ariane Lechasseur, PhD; Phone Number: 2652 418-656-8711; Email: ariane.lechasseur@criucpq.ulaval.ca
    • Principal Investigator: Mathieu C Morissette, PhD
    • Principal Investigator: Andréanne Côté, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Daily electronic cigarette users; Participants must use their vaping device everyday at time of enrollment.	Other: Vaping; Participants use their vaping products at their own discretion and their intake is monitored via questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	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.	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.	Every 3 months for 5 years

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Ministere de la Sante et des Services Sociaux
• Investigators: Principal Investigator: Mathieu C Morissette, PhD, Laval University

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: October 7, 2023
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Vaping; Electronic cigarette; Vape; Electronic and vaping acute lung injury; EVALI
• Other Study ID Numbers: 22071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No