Vaping Adverse Lung and Heart Events Cohort

Recruiting

• Conditions: Vaping; Electronic Cigarette Use
• Interventions: Other: Vaping

• Registration Number: NCT06291597
• Lead Sponsor: Laval University

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 Timeline

• Study Start: 2021-10-14
• Study First Submitted: 2023-10-07
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04
• Primary Completion: 2031-12
• Study Completion: 2032-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Daily electronic cigarette users	Vaping	Participants must use their vaping device everyday at time of enrollment.

Primary Outcome Measures

Name	Time	Method
Number of participants who vape daily with impaired lung volumes.	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.	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.	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.	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.	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.	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.	Every 3 months for 5 years	Participants will complete questionnaires assessing their vaping habits, tobacco smoking and cannabis smoking history.

Trial Locations

Locations (1)

IUCPQ-UL; 🇨🇦 Québec, Canada