The Canadian Lung Outcomes in Users of Vaping Devices Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorUniversity of British Columbia
About this trial
Vaping is increasingly popular with both adolescent and adult Canadians, but the long-term health impacts remain unknown. We believe that the tools we currently have to detect lung disease in people who vape may be insufficient and propose new ways to find lung injuries that may impact them over the course of their lives. These include exercise testing, new imaging techniques, and new breathing tests that will demonstrate how vaping may harm their lungs. We will use these tools in both adolescent and adult Canadians to give Canadians who vape important information on the consequences of vaping.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged ≥12 and <19 years old
Either 1) use neither combustible cigarettes nor e-cigarettes or 2) use e-cigarettes exclusively
Aged ≥19 years old
Fall into one of the following categories: 1) use neither combustible cigarettes nor e-cigarettes; 2) use combustible cigarettes exclusively, never using e-cigarettes; 3) use e-cigarettes exclusively, never using combustible cigarettes; or 4) use both combustible cigarettes and e-cigarettes currently
Disqualifiers
Contraindication to pulmonary function testing and cardiopulmonary exercise testing
Have smoked combustible cannabis within the last month and/or have a combustible cannabis smoking history of >1 joint-year
Have smoked combustible cigarettes within the last 6 months
Have a physician-diagnosed chronic lung disease (such as asthma, cystic fibrosis, or bronchopulmonary dysplasia)
Trial population
This study will enroll both adolescent (ages ≥12 and \<19 years) and adult (≥19 years) e-cigarette and non-e-cigarette users in six academic hospital centres across Canada.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsGroup A: Adults
Group B: Adolescents
Trial outcomes
Primary outcomes
1
Composite Measure of Small Airways Dysfunction
Participants meeting at least one of the following criteria will be considered to have small airways dysfunction: For adolescent participants, these measures will include 1) a change in resistance from 5-20 Hz (R5-R20) \>upper limit of normal (ULN) on oscillometry or 2) peak oxygen consumption (VO2)\<lower limit of normal (LLN) plus a ventilatory response or minute ventilation/carbon dioxide production (VE/VCO2) nadir \>ULN. For adult participants, these measures will include 1) R5-R20 \>ULN, 2) disease probability measure functional small airways disease \>10% on chest CT, or 3) peak VO2\<84% predicted plus a VE/VCO2 nadir \>ULN. The proportion of participants meeting at least one of the criteria for small airways dysfunction at any time point will be compared between the vaping and control groups using Chi-square tests. Multivariable logistic regressions will be used to adjust for possible covariates, such as age, sex, and their interaction with vaping/smoking groups.
Time frame
From enrollment (Baseline) to the end of study participation (36 Months).Secondary outcomes
1
FEV1
Outcome measured in units of Liters (L) for all study participants.
Time frame
36 Months2
FVC
Outcome measured in units of Liters (L) for all study participants.
Time frame
36 Months3
FEV1/FVC
Outcome measured in units of 0-100% for all study participants.
Time frame
36 Months4
FEV3/FEV6
Outcome measured in units of 0-100% for all study participants.
Time frame
36 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
BC Children's Hospital Research Institute
Collaborator
Providence Healthcare
Collaborator
British Columbia Cancer Agency
Collaborator
University of Alberta
Collaborator
McMaster University
Collaborator
University of Ottawa
Collaborator
Université de Sherbrooke
Collaborator
University of Toronto
Collaborator
Source ClinicalTrials.gov