Vaping Adverse Lung and Heart Events Cohort

Vaping Clinical Trial

— VapALERT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291597
• Other study ID #: 22071
• Status: Recruiting
• Start date: October 14, 2021
• Est. completion date: June 2032

Study information

• Verified date: February 2024
• Source: Laval University
• Contact: Ariane Lechasseur, PhD
• Phone: 418-656-8711
• Email: ariane.lechasseur[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 2032
• Est. primary completion date: December 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Electronic Cigarette Use
• Vaping

Intervention

Other:
• Vaping
Participants use their vaping products at their own discretion and their intake is monitored via questionnaires.

Locations

Country	Name	City	State
Canada	IUCPQ-UL	Québec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Ministere de la Sante et des Services Sociaux

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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