The Canadian Lung Outcomes in Users of Vaping Devices Study

NCT06819969 | Recruiting

• 2 other identifiers: H24-00374FRN-193735
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Small Airways Diseases; Vaping; Vaping Related Disorder; Vaping Teens; Vaping Behavior

Keywords

CLOUD; small airway injury; vaping; vape; e-cigarette; oscillometry; multiple breath washout; chest computed tomography; chest CT; hyperpolarized 129-xenon; MRI; CPET; bronchoscopy; transcriptomics; epigenetics

Outcome Measures

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.

  From enrollment (Baseline) to the end of study participation (36 Months).

Secondary Outcomes (30)

• FEV1

  36 Months

• FVC

  36 Months

• FEV1/FVC

  36 Months

• FEV3/FEV6

  36 Months

• Total Lung Capacity

  36 Months

Study Arms (2)

Adults

Canadian adults aged 19 years or older. We will be enrolling e-cigarette-only users, non-e-cigarette and non-combustible cigarette users, combustible cigarette-only users, and dual combustible cigarette-e-cigarette users.

Adolescents

Canadian adolescents aged between 12 and \<19 years, inclusive. We will be enrolling e-cigarette-only users, as well as non-e-cigarette and non-combustible cigarette users.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Adolescent arm:
• Aged ≥12 and \<19 years old
• Either 1) use neither combustible cigarettes nor e-cigarettes or 2) use e-cigarettes exclusively
• Adult arm:
• 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

You may not qualify if:

• Adolescent arm:
• 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)
• Inability to provide written informed consent
• Adult arm:
• 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
• Currently undergoing treatment for lung cancer
• Inability to provide written informed consent
• No limitations will be placed on the type of e-liquids used by participants; e.g., e-cigarette users of nicotine, tetrahydrocannabinol, and cannabidiol will be all enrolled.

Sponsors & Collaborators

• 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
• University of British Columbia: lead
• BC Children's Hospital Research Institute: collaborator

Study Sites (8)

University of Alberta (Clinical Sciences Building)

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

BC Children's Hospital Research Institute

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

McMaster University (Research Institute of St. Joe's Hamilton)

Hamilton, Ontario, L8N 4A6, Canada

NOT YET RECRUITING

University of Ottawa (The Ottawa Hospital General Campus)

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

University of Toronto (The Hospital for Sick Children)

Toronto, Ontario, M5G 1E8, Canada

NOT YET RECRUITING

Université de Sherbrooke

Sherbrooke, Quebec, J1N 3C6, Canada

NOT YET RECRUITING

Related Publications (1)

• Burns P, Eddy RL, Li X, Yang J, Dhillon SS, Couillard S, Stickland MK, Guenette J, Svenningsen S, Tulloch T, Samji H, Meza R, Struik LL, Aaron S, Ho T, Lam S, Leipsic J, Maclean J, Afshar T, Moraes TJ, Zanette B, Santyr G, Counil FP, Hernandez Cordero AI, Matano S, de Arruda Maluf G, Leung C, Feng C, Bal L, Dhaliwal H, Mumuni A, Lui C, Drew H, Sin DD, Rayment JH, Leung JM. The Canadian Lung Outcomes in Users of Vaping Devices (CLOUD) Study: protocol for a prospective, observational cohort study. BMJ Open. 2025 Mar 6;15(3):e100568. doi: 10.1136/bmjopen-2025-100568.

  PMID: 40050062 DERIVED

Related Links

• CLOUD Study website containing all details and contact information related to the study.

Biospecimen

Retention: SAMPLES WITH DNA

All cohorts: Blood Adolescent cohort: Induced Sputum Adult cohort: Airway Epithelium and Lung Immune Cells

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Janice Leung, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janice Leung, MD

CONTACT

604-836-0423; janice.leung@hli.ubc.ca

Paloma Burns, MSc

CONTACT

604-442-7021; pburns@providencehealth.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine, University of British Columbia, Principal Investigator, Centre for Heart Lung Innovation, St. Paul's Hospital, Respirologist, St. Paul's Hospital

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 11, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)