E Cigarette UseNCT04616313
Novel Pulmonary Imaging of Lung Structure and Function in E-cigarette Smokers
An observational study of E Cigarette Use, run by Western University, Canada at 1 site in Canada.
Trial summary
This is a longitudinal study of the long-term health impact of e-cigarette smoking on the lungs. Participants will be followed over a period of 5 years, and impacts of e-cigarette smoking on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129 gas, pulmonary function tests… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- E Cigarette Use
- What is being tested?
- Hyperpolarized Xenon-129 MRI of the lungs, Computed Tomography (CT) and Pulmonary Function Tests (PFT)
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. e-cigarette users who did not require hospitalization, nor used c-cigarettes 2. e-cigarette users who also consumed c-cigarettes 3. never smokers
Who may be able to join
- Written informed consent must be directly obtained from legally competent participants before any study-related assessment is performed.
- Male and female participant age ≥16 years.
- Participant has recently started vaping, >1 and <5 years weekly use.
- 70 participants will be c-cigarette never users.
- 70 participants will be former or current c-cigarette users.
- 10 asymptomatic age and sex-matched healthy people who have never used e- or c-cigarettes will be controls.
Who cannot join
- Participants with contraindications for undergoing an MRI such as participants with MRI-sensitive implants, tattoos with MRI-sensitive dye and severe claustrophobia.
- Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand written material.
- Participant unable to perform spirometry or plethysmography maneuvers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, N6A 5B7
Grace E Parraga, PhD, 519-931-5265, gparraga@uwo.ca
About this study
Official title: Novel Pulmonary Imaging of Lung Structure and Function in Symptomatic and Asymptomatic E-cigarette Smokers
This is a longitudinal study of the long-term health impact of e-cigarette smoking on the lungs. Participants will be followed over a period of 5 years, and impacts of e-cigarette smoking on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129 gas, pulmonary function tests, exercise capacity, computed tomography images and questionnaires.
Read the detailed description
This is a 5-year longitudinal study of the long-term lung health impact of e-cigarette smoking. Participants with a history of e-cigarette smoking age ≥ 16 years will be recruited from within 2 hours of London, ON through local family and tertiary care physicians, emergency departments and community and social media advertisements. Asymptomatic age and sex-matched participants who have never smoked e- or c-cigarettes will be recruited through community advertisement, media and social media. Participants must satisfy all inclusion and exclusion criteria in order to participate in the study. We will compare lung health of participants at baseline, 12 weeks, 24 weeks and 48 weeks, 3 years, 4 years and 5 years with an asymptomatic control group with no history of e-cigarette or c-cigarette use. The study will involve 6 in-person visits and 1 telephone call for a health update. All measurements will be made with at least 4 hours after the last cigarette and/or vape to provide a way to practically focus on chronic and not acute effects. Pulmonary function and imaging measurements will be made before and after bronchodilator administration.
At Visit 1, informed consent will be obtained before any study related assessments or procedures are performed. Eligibility criteria will be reviewed. Safety assessments including vital signs, pulmonary function testing, hematology, sputum sampling, exercise testing, and respiratory questionnaires will be completed.
Visit 2 will take place 12 weeks after visit 1 and will include vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, chest CT scan, exercise testing, and questionnaires.
Visit 3 will take place at 24 weeks and will involve a telephone call to update health information as well as questionnaires.
Visit 4 will take place at 48 weeks and will involve vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, hematology, blood chemistry, sputum analysis, exercise testing, and questionnaires.
Visit 5 will take place at year 3 and will involve vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, blood draw, sputum induction and analysis, exercise testing and questionnaires.
Visit 6 will take place at year 4 and will involve vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, blood draw, sputum induction and analysis, exercise testing and questionnaires.
Visit 7 will take place at year 5 and will involve vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, blood draw, sputum induction and analysis, exercise testing and questionnaires.
- Conditions
- E Cigarette Use
- Being tested
- Hyperpolarized Xenon-129 MRI of the lungs, Computed Tomography (CT), Pulmonary Function Tests (PFT), Cardiopulmonary exercise testing (CPET), Sputum analysis
- Keywords
- e-cigarette smoking, pulmonary function, Xenon-129, Magnetic Resonance Imaging
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Xenon-129 MRI of the lungsDiagnostic test
Also called 129Xe MRI
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Computed Tomography (CT)Diagnostic test
Also called CT
Participants will undergo a CT scan of the thoracic cavity
Pulmonary Function Tests (PFT)Diagnostic test
Also called PFT
Participants will have their lung function evaluated using PFT
Cardiopulmonary exercise testing (CPET)Diagnostic test
Also called CPET
Participants will perform cardiopulmonary exercise testing as a measure of exercise capacity
Sputum analysisDiagnostic test
Participants will provide a sputum sample that will be analysed for eosinophils
Blood analysisDiagnostic test
Participants will have their blood drawn and analysed for eosinophil count.
QuestionnairesOther
Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
| Study group | Role | What they receive |
|---|---|---|
| c-cigarette never users | Includes 70 participants who are e-cigarette users who have never smoked combustible cigarettes. Receives: Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs; Diagnostic Test: Computed Tomography (CT); Diagnostic Test: Pulmonary Function Tests (PFT); Diagnostic Test: Cardiopulmonary exercise testing (CPET); Diagnostic Test: Sputum analysis; Diagnostic Test: Blood analysis; Other: Questionnaires | |
| former or current c-cigarette users | Includes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers. Receives: Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs; Diagnostic Test: Computed Tomography (CT); Diagnostic Test: Pulmonary Function Tests (PFT); Diagnostic Test: Cardiopulmonary exercise testing (CPET); Diagnostic Test: Sputum analysis; Diagnostic Test: Blood analysis; Other: Questionnaires | |
| never smokers | Includes 10 participants who have never smoked e-cigarettes or combustible cigarettes. Receives: Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs; Diagnostic Test: Computed Tomography (CT); Diagnostic Test: Pulmonary Function Tests (PFT); Diagnostic Test: Cardiopulmonary exercise testing (CPET); Diagnostic Test: Sputum analysis; Diagnostic Test: Blood analysis; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities.
Measured using 129-Xe MRI
Measured: 12 weeks following enrollment
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities.
Measured using computed tomography imaging
Measured: 12 weeks following enrollment
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FEV1.
Measured using forced expiratory volume in one second (FEV1)
Measured: 12 weeks following enrollment
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FVC.
Measured using forced vital capacity (FVC)
Measured: 12 weeks following enrollment
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by TLC.
Measured using total lung capacity (TLC)
Measured: 12 weeks following enrollment
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FRC.
Measured using functional residual capacity (FRC)
Measured: 12 weeks following enrollment
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by RV.
Measured using residual volume (RV)
Measured: 12 weeks following enrollment
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FOT.
Measured using forced oscillation technique (FOT)
Measured: 12 weeks following enrollment
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by LCI.
Measured using lung clearance index (LCI)
Measured: 12 weeks following enrollment
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FeNO.
Measured using Fractional Exhaled Nitric Oxide (FeNO).
Measured: 12 weeks following enrollment
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by exercise capacity
Exercise capacity measured by cardio-pulmonary exercise testing (CPET)
Measured: 12 weeks following enrollment
Secondary outcomes (19)
Differences in airways between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers.
Measured using 129-Xe MRI
Measured: 5 years
Differences in airways between e-cigarette-only smokers and never smokers.
Measured using 129-Xe MRI
Measured: 5 years
Differences in parenchyma between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers.
Measured using 129-Xe MRI
Measured: 5 years
Differences in parenchyma between e-cigarette-only smokers and never smokers.
Measured using 129-Xe MRI
Measured: 5 years
Changes in airways of e-cigarette smokers over time.
Measured using Xenon-129 (129-Xe) MRI
Measured: 5 years
Changes in parenchyma of e-cigarette smokers over time.
Measured using Xenon-129 (129-Xe) MRI
Measured: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FEV1.
Measured using forced expiratory volume in one second (FEV1).
Measured: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FVC.
Measured using forced vital capacity (FVC)
Measured: 5 years
Changes in lung function of e-cigarette smokers over time as measured by TLC.
Measured using total lung capacity (TLC)
Measured: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FRC.
Measured using functional residual capacity (FRC)
Measured: 5 years
Changes in lung function of e-cigarette smokers over time as measured by RV.
Measured using residual volume (RV)
Measured: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FOT.
Measured using forced oscillation technique (FOT).
Measured: 5 years
Changes in lung function of e-cigarette smokers over time as measured by LCI.
Measured using lung clearance index (LCI)
Measured: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FeNO.
Measured using Fractional Exhaled Nitric Oxide (FeNO)
Measured: 5 years
Changes in lung function of e-cigarette smokers over time as measured by exercise capacity.
Exercise capacity measured by cardio-pulmonary exercise testing (CPET)
Measured: 5 years
Changes in lung health of e-cigarette smokers over time as measured by the mMRC dyspnea scale questionnaire.
Measured using the modified medical research council (mMRC) dyspnea scale
Measured: 5 years
Changes in lung health of e-cigarette smokers over time as measured by SGRQ.
Measured using the St. George's respiratory questionnaire (SGRQ)
Measured: 5 years
Changes in lung health of e-cigarette smokers over time as measured by CAT.
Measured using the COPD assessment test (CAT)
Measured: 5 years
Changes in lung health of e-cigarette smokers over time as measured by IPAQ.
Measured using the International Physical Activity Questionnaire (IPAQ).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start17 Jan 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for E Cigarette UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre
- Responsible party
- Principal investigator, Dr. Grace Parraga, Western University, Canada
- Investigators
- Grace E Parraga, Principal investigator, Western University - Robarts Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616313
- Sponsor's protocol ID
- ROB0048
- Status last verified
- Aug 2025
- First submitted
- 2 Nov 2020
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hua M, Alfi M, Talbot P. Health-related effects reported by electronic cigarette users in online forums. J Med Internet Res. 2013 Apr 8;15(4):e59. doi: 10.2196/jmir.2324.
PubMed 23567935Wang MP, Ho SY, Leung LT, Lam TH. Electronic Cigarette Use and Respiratory Symptoms in Chinese Adolescents in Hong Kong. JAMA Pediatr. 2016 Jan;170(1):89-91. doi: 10.1001/jamapediatrics.2015.3024. No abstract available.
PubMed 26551991McConnell R, Barrington-Trimis JL, Wang K, Urman R, Hong H, Unger J, Samet J, Leventhal A, Berhane K. Electronic Cigarette Use and Respiratory Symptoms in Adolescents. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1043-1049. doi: 10.1164/rccm.201604-0804OC.
PubMed 27806211Cho JH, Paik SY. Association between Electronic Cigarette Use and Asthma among High School Students in South Korea. PLoS One. 2016 Mar 4;11(3):e0151022. doi: 10.1371/journal.pone.0151022. eCollection 2016.
PubMed 26942764Schweitzer RJ, Wills TA, Tam E, Pagano I, Choi K. E-cigarette use and asthma in a multiethnic sample of adolescents. Prev Med. 2017 Dec;105:226-231. doi: 10.1016/j.ypmed.2017.09.023. Epub 2017 Sep 28.
PubMed 28964850Layden JE, Ghinai I, Pray I, Kimball A, Layer M, Tenforde MW, Navon L, Hoots B, Salvatore PP, Elderbrook M, Haupt T, Kanne J, Patel MT, Saathoff-Huber L, King BA, Schier JG, Mikosz CA, Meiman J. Pulmonary Illness Related to E-Cigarette Use in Illinois and Wisconsin - Final Report. N Engl J Med. 2020 Mar 5;382(10):903-916. doi: 10.1056/NEJMoa1911614. Epub 2019 Sep 6.
PubMed 31491072Henry TS, Kanne JP, Kligerman SJ. Imaging of Vaping-Associated Lung Disease. N Engl J Med. 2019 Oct 10;381(15):1486-1487. doi: 10.1056/NEJMc1911995. Epub 2019 Sep 6. No abstract available.
PubMed 31491070Maddock SD, Cirulis MM, Callahan SJ, Keenan LM, Pirozzi CS, Raman SM, Aberegg SK. Pulmonary Lipid-Laden Macrophages and Vaping. N Engl J Med. 2019 Oct 10;381(15):1488-1489. doi: 10.1056/NEJMc1912038. Epub 2019 Sep 6. No abstract available.
PubMed 31491073Davidson K, Brancato A, Heetderks P, Mansour W, Matheis E, Nario M, Rajagopalan S, Underhill B, Wininger J, Fox D. Outbreak of Electronic-Cigarette-Associated Acute Lipoid Pneumonia - North Carolina, July-August 2019. MMWR Morb Mortal Wkly Rep. 2019 Sep 13;68(36):784-786. doi: 10.15585/mmwr.mm6836e1.
PubMed 31513559Landman ST, Dhaliwal I, Mackenzie CA, Martinu T, Steel A, Bosma KJ. Life-threatening bronchiolitis related to electronic cigarette use in a Canadian youth. CMAJ. 2019 Dec 2;191(48):E1321-E1331. doi: 10.1503/cmaj.191402. Epub 2019 Nov 20.
PubMed 31753841Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
PubMed 14680096Kirby M, Heydarian M, Svenningsen S, Wheatley A, McCormack DG, Etemad-Rezai R, Parraga G. Hyperpolarized 3He magnetic resonance functional imaging semiautomated segmentation. Acad Radiol. 2012 Feb;19(2):141-52. doi: 10.1016/j.acra.2011.10.007. Epub 2011 Nov 21.
PubMed 22104288Owrangi AM, Etemad-Rezai R, McCormack DG, Cunningham IA, Parraga G. Computed tomography density histogram analysis to evaluate pulmonary emphysema in ex-smokers. Acad Radiol. 2013 May;20(5):537-45. doi: 10.1016/j.acra.2012.11.010.
PubMed 23570935Pizzichini E, Pizzichini MM, Efthimiadis A, Evans S, Morris MM, Squillace D, Gleich GJ, Dolovich J, Hargreave FE. Indices of airway inflammation in induced sputum: reproducibility and validity of cell and fluid-phase measurements. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):308-17. doi: 10.1164/ajrccm.154.2.8756799.
PubMed 8756799
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Pulmonary Imaging of Lung Structure and Function in Symptomatic and Asymptomatic E-cigarette Smokers
- ClinicalTrials.gov ID
- NCT04616313
- Acronym / sponsor ID
- ROB0048
- Conditions
- E Cigarette Use
- Keywords
- e-cigarette smoking, pulmonary function, Xenon-129, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- London Health Sciences Centre
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a longitudinal study of the long-term health impact of e-cigarette smoking on the lungs. Participants will be followed over a period of 5 years, and impacts of e-cigarette smoking on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129 gas, pulmonary function tests, exercise capacity, computed tomography images and questionnaires.
Detailed description
This is a 5-year longitudinal study of the long-term lung health impact of e-cigarette smoking. Participants with a history of e-cigarette smoking age ≥ 16 years will be recruited from within 2 hours of London, ON through local family and tertiary care physicians, emergency departments and community and social media advertisements. Asymptomatic age and sex-matched participants who have never smoked e- or c-cigarettes will be recruited through community advertisement, media and social media. Participants must satisfy all inclusion and exclusion criteria in order to participate in the study. We will compare lung health of participants at baseline, 12 weeks, 24 weeks and 48 weeks, 3 years, 4 years and 5 years with an asymptomatic control group with no history of e-cigarette or c-cigarette use. The study will involve 6 in-person visits and 1 telephone call for a health update. All measurements will be made with at least 4 hours after the last cigarette and/or vape to provide a way to practically focus on chronic and not acute effects. Pulmonary function and imaging measurements will be made before and after bronchodilator administration.
At Visit 1, informed consent will be obtained before any study related assessments or procedures are performed. Eligibility criteria will be reviewed. Safety assessments including vital signs, pulmonary function testing, hematology, sputum sampling, exercise testing, and respiratory questionnaires will be completed.
Visit 2 will take place 12 weeks after visit 1 and will include vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, chest CT scan, exercise testing, and questionnaires.
Visit 3 will take place at 24 weeks and will involve a telephone call to update health information as well as questionnaires.
Visit 4 will take place at 48 weeks and will involve vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, hematology, blood chemistry, sputum analysis, exercise testing, and questionnaires.
Visit 5 will take place at year 3 and will involve vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, blood draw, sputum induction and analysis, exercise testing and questionnaires.
Visit 6 will take place at year 4 and will involve vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, blood draw, sputum induction and analysis, exercise testing and questionnaires.
Visit 7 will take place at year 5 and will involve vital signs, pre and post bronchodilator pulmonary function testing, pre and post bronchodilator MRI imaging, blood draw, sputum induction and analysis, exercise testing and questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| c-cigarette never users | – | Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs, Diagnostic Test: Computed Tomography (CT), Diagnostic Test: Pulmonary Function Tests (PFT), Diagnostic Test: Cardiopulmonary exercise testing (CPET), Diagnostic Test: Sputum analysis, Diagnostic Test: Blood analysis, Other: QuestionnairesIncludes 70 participants who are e-cigarette users who have never smoked combustible cigarettes. |
| former or current c-cigarette users | – | Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs, Diagnostic Test: Computed Tomography (CT), Diagnostic Test: Pulmonary Function Tests (PFT), Diagnostic Test: Cardiopulmonary exercise testing (CPET), Diagnostic Test: Sputum analysis, Diagnostic Test: Blood analysis, Other: QuestionnairesIncludes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers. |
| never smokers | – | Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs, Diagnostic Test: Computed Tomography (CT), Diagnostic Test: Pulmonary Function Tests (PFT), Diagnostic Test: Cardiopulmonary exercise testing (CPET), Diagnostic Test: Sputum analysis, Diagnostic Test: Blood analysis, Other: QuestionnairesIncludes 10 participants who have never smoked e-cigarettes or combustible cigarettes. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. e-cigarette users who did not require hospitalization, nor used c-cigarettes 2. e-cigarette users who also consumed c-cigarettes 3. never smokers
Key inclusion criteria (6 listed)
- Written informed consent must be directly obtained from legally competent participants before any study-related assessment is performed.
- Male and female participant age ≥16 years.
- Participant has recently started vaping, >1 and <5 years weekly use.
- 70 participants will be c-cigarette never users.
- 70 participants will be former or current c-cigarette users.
Key exclusion criteria (3 listed)
- Participants with contraindications for undergoing an MRI such as participants with MRI-sensitive implants, tattoos with MRI-sensitive dye and severe claustrophobia.
- Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand written material.
- Participant unable to perform spirometry or plethysmography maneuvers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized Xenon-129 MRI of the lungsAlso: 129Xe MRIParticipants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas | Diagnostic test | c-cigarette never users, former or current c-cigarette users, never smokers |
| Computed Tomography (CT)Also: CTParticipants will undergo a CT scan of the thoracic cavity | Diagnostic test | c-cigarette never users, former or current c-cigarette users, never smokers |
| Pulmonary Function Tests (PFT)Also: PFTParticipants will have their lung function evaluated using PFT | Diagnostic test | c-cigarette never users, former or current c-cigarette users, never smokers |
| Cardiopulmonary exercise testing (CPET)Also: CPETParticipants will perform cardiopulmonary exercise testing as a measure of exercise capacity | Diagnostic test | c-cigarette never users, former or current c-cigarette users, never smokers |
| Sputum analysisParticipants will provide a sputum sample that will be analysed for eosinophils | Diagnostic test | c-cigarette never users, former or current c-cigarette users, never smokers |
| Blood analysisParticipants will have their blood drawn and analysed for eosinophil count. | Diagnostic test | c-cigarette never users, former or current c-cigarette users, never smokers |
| QuestionnairesParticipants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life. | Other | c-cigarette never users, former or current c-cigarette users, never smokers |
Primary outcome
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities.
Time frame: 12 weeks following enrollment
Measured using 129-Xe MRI
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities.
Time frame: 12 weeks following enrollment
Measured using computed tomography imaging
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FEV1.
Time frame: 12 weeks following enrollment
Measured using forced expiratory volume in one second (FEV1)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FVC.
Time frame: 12 weeks following enrollment
Measured using forced vital capacity (FVC)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by TLC.
Time frame: 12 weeks following enrollment
Measured using total lung capacity (TLC)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FRC.
Time frame: 12 weeks following enrollment
Measured using functional residual capacity (FRC)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by RV.
Time frame: 12 weeks following enrollment
Measured using residual volume (RV)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FOT.
Time frame: 12 weeks following enrollment
Measured using forced oscillation technique (FOT)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by LCI.
Time frame: 12 weeks following enrollment
Measured using lung clearance index (LCI)
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FeNO.
Time frame: 12 weeks following enrollment
Measured using Fractional Exhaled Nitric Oxide (FeNO).
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by exercise capacity
Time frame: 12 weeks following enrollment
Exercise capacity measured by cardio-pulmonary exercise testing (CPET)
19 secondary outcomes
Differences in airways between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers.
Time frame: 5 years
Differences in airways between e-cigarette-only smokers and never smokers.
Time frame: 5 years
Differences in parenchyma between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers.
Time frame: 5 years
Differences in parenchyma between e-cigarette-only smokers and never smokers.
Time frame: 5 years
Changes in airways of e-cigarette smokers over time.
Time frame: 5 years
Changes in parenchyma of e-cigarette smokers over time.
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FEV1.
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FVC.
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by TLC.
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FRC.
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by RV.
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FOT.
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by LCI.
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FeNO.
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by exercise capacity.
Time frame: 5 years
Changes in lung health of e-cigarette smokers over time as measured by the mMRC dyspnea scale questionnaire.
Time frame: 5 years
Changes in lung health of e-cigarette smokers over time as measured by SGRQ.
Time frame: 5 years
Changes in lung health of e-cigarette smokers over time as measured by CAT.
Time frame: 5 years
Changes in lung health of e-cigarette smokers over time as measured by IPAQ.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 23567935Hua M, Alfi M, Talbot P. Health-related effects reported by electronic cigarette users in online forums. J Med Internet Res. 2013 Apr 8;15(4):e59. doi: 10.2196/jmir.2324.
- Background: PubMed 26551991Wang MP, Ho SY, Leung LT, Lam TH. Electronic Cigarette Use and Respiratory Symptoms in Chinese Adolescents in Hong Kong. JAMA Pediatr. 2016 Jan;170(1):89-91. doi: 10.1001/jamapediatrics.2015.3024. No abstract available.
- Background: PubMed 27806211McConnell R, Barrington-Trimis JL, Wang K, Urman R, Hong H, Unger J, Samet J, Leventhal A, Berhane K. Electronic Cigarette Use and Respiratory Symptoms in Adolescents. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1043-1049. doi: 10.1164/rccm.201604-0804OC.
- Background: PubMed 26942764Cho JH, Paik SY. Association between Electronic Cigarette Use and Asthma among High School Students in South Korea. PLoS One. 2016 Mar 4;11(3):e0151022. doi: 10.1371/journal.pone.0151022. eCollection 2016.
- Background: PubMed 28964850Schweitzer RJ, Wills TA, Tam E, Pagano I, Choi K. E-cigarette use and asthma in a multiethnic sample of adolescents. Prev Med. 2017 Dec;105:226-231. doi: 10.1016/j.ypmed.2017.09.023. Epub 2017 Sep 28.
- Background: PubMed 31491072Layden JE, Ghinai I, Pray I, Kimball A, Layer M, Tenforde MW, Navon L, Hoots B, Salvatore PP, Elderbrook M, Haupt T, Kanne J, Patel MT, Saathoff-Huber L, King BA, Schier JG, Mikosz CA, Meiman J. Pulmonary Illness Related to E-Cigarette Use in Illinois and Wisconsin - Final Report. N Engl J Med. 2020 Mar 5;382(10):903-916. doi: 10.1056/NEJMoa1911614. Epub 2019 Sep 6.
- Background: PubMed 31491070Henry TS, Kanne JP, Kligerman SJ. Imaging of Vaping-Associated Lung Disease. N Engl J Med. 2019 Oct 10;381(15):1486-1487. doi: 10.1056/NEJMc1911995. Epub 2019 Sep 6. No abstract available.
- Background: PubMed 31491073Maddock SD, Cirulis MM, Callahan SJ, Keenan LM, Pirozzi CS, Raman SM, Aberegg SK. Pulmonary Lipid-Laden Macrophages and Vaping. N Engl J Med. 2019 Oct 10;381(15):1488-1489. doi: 10.1056/NEJMc1912038. Epub 2019 Sep 6. No abstract available.
- Background: PubMed 31513559Davidson K, Brancato A, Heetderks P, Mansour W, Matheis E, Nario M, Rajagopalan S, Underhill B, Wininger J, Fox D. Outbreak of Electronic-Cigarette-Associated Acute Lipoid Pneumonia - North Carolina, July-August 2019. MMWR Morb Mortal Wkly Rep. 2019 Sep 13;68(36):784-786. doi: 10.15585/mmwr.mm6836e1.
- Background: PubMed 31753841Landman ST, Dhaliwal I, Mackenzie CA, Martinu T, Steel A, Bosma KJ. Life-threatening bronchiolitis related to electronic cigarette use in a Canadian youth. CMAJ. 2019 Dec 2;191(48):E1321-E1331. doi: 10.1503/cmaj.191402. Epub 2019 Nov 20.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Background: PubMed 14680096Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grace E Parraga principal investigator
Western University - Robarts Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of E Cigarette Use, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grace E Parraga, PhD (519-931-5265, gparraga@robarts.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities. (time frame: 12 weeks following enrollment). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616313, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.