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| ID | Type | Description | Link |
|---|---|---|---|
| FRN-193735 | Other Grant/Funding Number | Canadian Institutes of Health Research (CIHR) | |
| FRN-193735 | Other Grant/Funding Number | Heart and Stroke Foundation | |
| FRN-193735 | Other Grant/Funding Number | Canadian Cancer Society |
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| Name | Class |
|---|---|
| BC Children's Hospital Research Institute | OTHER |
| Providence Healthcare | OTHER |
| British Columbia Cancer Agency | OTHER |
| University of Alberta |
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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.
Promoted as a safer method of inhaling nicotine compared to cigarettes and as smoking cessation tools, e-cigarettes have substantially grown in popularity with rates of uptake now exceeding those of cigarette smoking. In Canada, 6% of Canadians aged 15 years and older have vaped in the past 30 days. Younger Canadians appear to be the most susceptible to these habits, with 14% of those aged 15-19 years and 18% of those aged 20-24 years reporting past 30 day use. Indigenous populations are also disproportionately affected by the spread of vaping which may place them at higher risk for potential downstream respiratory complications. As Canadians increasingly reach for e-cigarettes, especially at younger ages and not just for the purposes of smoking cessation, greater clarity into the pulmonary toxicities vaping is urgently needed.
The Canadian Lung Outcomes in Users of Vaping Devices (CLOUD) Study is a pan-Canadian, multicentre, multidisciplinary, and longitudinal approach to studying vaping from cell to society. The characterization of e-cigarettes' respiratory effects remains superficial and a more comprehensive phenotyping of vaping-exposed lungs across the lifespan using novel imaging and pulmonary function techniques, dynamic exercise testing, and airway cell sequencing would significantly enhance our understanding of the potential harms. As with combustible cigarette smoking, the small airways (characterized by a diameter <2mm) may be particularly vulnerable during vaping given their high degree of exposure to particulate matter. These regions of the lung may harbour the earliest signs of injury, ultimately setting the stage for future obstructive airways disease.
Objectives
The objective of the CLOUD Study is to characterize small airway injury in adolescent and adult Canadians who use e-cigarettes. Specifically, our goals are to:
Methods Our observational, longitudinal cohort study encompasses six academic hospital centres across Canada (the University of British Columbia, the University of Alberta, McMaster University, the University of Ottawa, the University of Toronto, and the Université de Sherbrooke). Participants (n=100 ages >12 and <19 years and n=400 ages ≥19 years) will be followed over 3 years, undergoing repeat demographic and respiratory symptom questionnaires, oscillometry, pulmonary function testing, and exercise testing. Adolescent participants will additionally undergo multiple breath washout and induced sputum collection and adult participants will undergo chest CT imaging and bronchoscopy. A substudy of adolescent and adult participants undergoing pulmonary hyperpolarized 129-xenon gas magnetic resonance imaging will also be performed. Induced sputum and bronchoscopy-derived airway epithelial and bronchoalveolar lavage samples will be sequenced for methylation and transcriptomics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 | Outcome measured in units of Liters (L) for all study participants. | 36 Months |
| FVC | Outcome measured in units of Liters (L) for all study participants. |
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Inclusion Criteria:
Adolescent arm:
Adult arm:
Exclusion Criteria:
Adolescent arm:
Adult arm:
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janice Leung, MD | Contact | 604-836-0423 | janice.leung@hli.ubc.ca | |
| Paloma Burns, MSc | Contact | 604-442-7021 | pburns@providencehealth.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Janice Leung, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta (Clinical Sciences Building) | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40050062 | Derived | 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. |
| Label | URL |
|---|---|
| CLOUD Study website containing all details and contact information related to the study. | View source |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| OTHER |
| McMaster University | OTHER |
| University of Ottawa | OTHER |
| Université de Sherbrooke | OTHER |
| University of Toronto | OTHER |
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All cohorts: Blood Adolescent cohort: Induced Sputum Adult cohort: Airway Epithelium and Lung Immune Cells
| 36 Months |
| FEV1/FVC | Outcome measured in units of 0-100% for all study participants. | 36 Months |
| FEV3/FEV6 | Outcome measured in units of 0-100% for all study participants. | 36 Months |
| Total Lung Capacity | Outcome measured in units of Liters (L) for all study participants. | 36 Months |
| Diffusion Capacity | Outcome measured in units of mL/min/mmHg for all study participants. | 36 Months |
| Small Airways Resistance R5-R20 | Outcome measured in units of kPa/l/s for all study participants. | 36 Months |
| Ventilation Defect Percent | Outcomes measured in units of 0-100% for study participants in the following sites: St. Paul's Hospital (University of British Columbia), BC Children's Hospital (University of British Columbia), the Hospital for Sick Children (University of Toronto), St. Joseph's Healthcare Hamilton (McMaster University). | 36 Months |
| RBC to Membrane Ratio | Outcomes measured in units of a ratio for study participants in the following sites: St. Paul's Hospital (University of British Columbia), BC Children's Hospital (University of British Columbia), the Hospital for Sick Children (University of Toronto), St. Joseph's Healthcare Hamilton (McMaster University). | 36 Months |
| Membrane to Gas Ratio | Outcomes measured in units of a ratio for study participants in the following sites: St. Paul's Hospital (University of British Columbia), BC Children's Hospital (University of British Columbia), the Hospital for Sick Children (University of Toronto), St. Joseph's Healthcare Hamilton (McMaster University). | 36 Months |
| Apparent Diffusion Coefficient | Outcomes measured in units of cm2/s for study participants in the following sites: St. Paul's Hospital (University of British Columbia), BC Children's Hospital (University of British Columbia), the Hospital for Sick Children (University of Toronto), St. Joseph's Healthcare Hamilton (McMaster University). | 36 Months |
| Peak VO2 %predicted | Outcomes measured in units of 0-100% for all study participants. | 36 Months |
| VE/VCO2 nadir | Outcomes measured in units of a ratio for all study participants. | 36 Months |
| Epigenetic Age (Blood Methylation) | Outcomes measured in units of age acceleration residual for all study participants. | 36 Months |
| Differentially Methylated Genes (Blood Methylation) | Outcomes measured in units of beta-values for all study participants. | 36 Months |
| Differentially Expressed Genes (Blood Transcriptome) | Outcomes measured in units of transcripts per million for all study participants. | 36 Months |
| Epigenetic Age (Induced Sputum Methylation) | Outcomes measured in units of age acceleration residual for adolescent study participants in the following sites: BC Children's Hospital (University of British Columbia), the Hospital for Sick Children (University of Toronto), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke). | 36 Months |
| Differentially Methylated Genes (Induced Sputum Methylation) | Outcomes measured in units of beta-values for adolescent study participants in the following sites: BC Children's Hospital (University of British Columbia), the Hospital for Sick Children (University of Toronto), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke). | 36 Months |
| Differentially Expressed Genes (Induced Sputum Transcriptome) | Outcomes measured in units of transcripts per million for adolescent study participants in the following sites: BC Children's Hospital (University of British Columbia), the Hospital for Sick Children (University of Toronto), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke). | 36 Months |
| Epigenetic Age (Bronchial Epithelial Cell and Bronchoalveolar Lavage Methylation) | Outcomes measured in units of age acceleration residual for adult study participants in the following sites: St. Paul's Hospital (University of British Columbia), St. Joseph's Healthcare Hamilton (McMaster University), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke). | 36 Months |
| Differentially Methylated Genes (Bronchial Epithelial Cell and Bronchoalveolar Lavage Methylation) | Outcomes measured in units of beta-values for adult study participants in the following sites: St. Paul's Hospital (University of British Columbia), St. Joseph's Healthcare Hamilton (McMaster University), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke). | 36 Months |
| Differentially Expressed Genes (Bronchial Epithelial Cell and Bronchoalveolar Lavage Transcriptome) | Outcomes measured in units of transcripts per million for adult study participants in the following sites: St. Paul's Hospital (University of British Columbia), St. Joseph's Healthcare Hamilton (McMaster University), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke). | 36 Months |
| Lung Clearance Index | Outcomes measured in counts for adolescent study participants in the following sites: BC Children's Hospital (University of British Columbia), the Hospital for Sick Children (University of Toronto). | 36 Months |
| DPM fSAD | Outcomes measured in units of 0-100% for adult study participants in the following sites: St. Paul's Hospital (University of British Columbia), St. Joseph's Healthcare Hamilton (McMaster University), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke), Clinical Sciences Building (University of Alberta), Ottawa Hospital General Campus (University of Ottawa). | 36 Months |
| LAA856 | Outcomes measured in units of 0-100% for adult study participants in the following sites: St. Paul's Hospital (University of British Columbia), St. Joseph's Healthcare Hamilton (McMaster University), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke), Clinical Sciences Building (University of Alberta), Ottawa Hospital General Campus (University of Ottawa). | 36 Months |
| LAA950 (Quantitative Emphysema) | Outcomes measured in units of 0-100% for adult study participants in the following sites: St. Paul's Hospital (University of British Columbia), St. Joseph's Healthcare Hamilton (McMaster University), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke), Clinical Sciences Building (University of Alberta), Ottawa Hospital General Campus (University of Ottawa). | 36 Months |
| Qualitative Emphysema | Outcomes measured in units of 0-100% for adult study participants in the following sites: St. Paul's Hospital (University of British Columbia), St. Joseph's Healthcare Hamilton (McMaster University), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke), Clinical Sciences Building (University of Alberta), Ottawa Hospital General Campus (University of Ottawa). | 36 Months |
| Pulmonary Vascular Volume | Outcomes measured in units of milliliters (mL) for adult study participants in the following sites: St. Paul's Hospital (University of British Columbia), St. Joseph's Healthcare Hamilton (McMaster University), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke), Clinical Sciences Building (University of Alberta), Ottawa Hospital General Campus (University of Ottawa). | 36 Months |
| Mucus Score | Outcomes measured in counts for adult study participants in the following sites: St. Paul's Hospital (University of British Columbia), St. Joseph's Healthcare Hamilton (McMaster University), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke), Clinical Sciences Building (University of Alberta), Ottawa Hospital General Campus (University of Ottawa). | 36 Months |
| Total Airway Counts | Outcomes measured in counts for adult study participants in the following sites: St. Paul's Hospital (University of British Columbia), St. Joseph's Healthcare Hamilton (McMaster University), Centre Hospitalier Universitaire de Sherbrooke (Universite de Sherbrooke), Clinical Sciences Building (University of Alberta), Ottawa Hospital General Campus (University of Ottawa). | 36 Months |
| BC Cancer Agency | Recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
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| BC Children's Hospital Research Institute | Recruiting | Vancouver | British Columbia | V6H 3N1 | Canada |
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| St. Paul's Hospital | Recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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| McMaster University (Research Institute of St. Joe's Hamilton) | Not yet recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
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| University of Ottawa (The Ottawa Hospital General Campus) | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| University of Toronto (The Hospital for Sick Children) | Not yet recruiting | Toronto | Ontario | M5G 1E8 | Canada |
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| Université de Sherbrooke | Not yet recruiting | Sherbrooke | Quebec | J1N 3C6 | Canada |
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