NCT04616313

Brief 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, exercise capacity, computed tomography images and questionnaires.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jan 2023Dec 2027

First Submitted

Initial submission to the registry

November 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

4.9 years

First QC Date

November 2, 2020

Last Update Submit

August 8, 2025

Conditions

E Cigarette Use

Keywords

e-cigarette smokingpulmonary functionXenon-129Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (11)

  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities.

    Measured using 129-Xe MRI

    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

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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).

    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)

    12 weeks following enrollment

Secondary Outcomes (19)

  • Differences in airways between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers.

    5 years

  • Differences in airways between e-cigarette-only smokers and never smokers.

    5 years

  • Differences in parenchyma between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers.

    5 years

  • Differences in parenchyma between e-cigarette-only smokers and never smokers.

    5 years

  • Changes in airways of e-cigarette smokers over time.

    5 years

  • +14 more secondary outcomes

Study Arms (3)

c-cigarette never users

Includes 70 participants who are e-cigarette users who have never smoked combustible cigarettes.

Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungsDiagnostic Test: Computed Tomography (CT)Diagnostic Test: Pulmonary Function Tests (PFT)Diagnostic Test: Cardiopulmonary exercise testing (CPET)Diagnostic Test: Sputum analysisDiagnostic Test: Blood analysisOther: Questionnaires

former or current c-cigarette users

Includes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers.

Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungsDiagnostic Test: Computed Tomography (CT)Diagnostic Test: Pulmonary Function Tests (PFT)Diagnostic Test: Cardiopulmonary exercise testing (CPET)Diagnostic Test: Sputum analysisDiagnostic Test: Blood analysisOther: Questionnaires

never smokers

Includes 10 participants who have never smoked e-cigarettes or combustible cigarettes.

Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungsDiagnostic Test: Computed Tomography (CT)Diagnostic Test: Pulmonary Function Tests (PFT)Diagnostic Test: Cardiopulmonary exercise testing (CPET)Diagnostic Test: Sputum analysisDiagnostic Test: Blood analysisOther: Questionnaires

Interventions

Hyperpolarized Xenon-129 MRI of the lungsDIAGNOSTIC_TEST

Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas

Also known as: 129Xe MRI
c-cigarette never usersformer or current c-cigarette usersnever smokers
Computed Tomography (CT)DIAGNOSTIC_TEST

Participants will undergo a CT scan of the thoracic cavity

Also known as: CT
c-cigarette never usersformer or current c-cigarette usersnever smokers
Pulmonary Function Tests (PFT)DIAGNOSTIC_TEST

Participants will have their lung function evaluated using PFT

Also known as: PFT
c-cigarette never usersformer or current c-cigarette usersnever smokers
Cardiopulmonary exercise testing (CPET)DIAGNOSTIC_TEST

Participants will perform cardiopulmonary exercise testing as a measure of exercise capacity

Also known as: CPET
c-cigarette never usersformer or current c-cigarette usersnever smokers
Sputum analysisDIAGNOSTIC_TEST

Participants will provide a sputum sample that will be analysed for eosinophils

c-cigarette never usersformer or current c-cigarette usersnever smokers
Blood analysisDIAGNOSTIC_TEST

Participants will have their blood drawn and analysed for eosinophil count.

c-cigarette never usersformer or current c-cigarette usersnever smokers
QuestionnairesOTHER

Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.

c-cigarette never usersformer or current c-cigarette usersnever smokers

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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.
  • participants will be c-cigarette never users.
  • participants will be former or current c-cigarette users.
  • asymptomatic age and sex-matched healthy people who have never used e- or c-cigarettes will be controls.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

London, Ontario, N6A 5B7, Canada

RECRUITING

Related Publications (19)

  • 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.

    PMID: 23567935BACKGROUND

  • Wang 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.

    PMID: 26551991BACKGROUND

  • McConnell 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.

    PMID: 27806211BACKGROUND

  • Cho 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.

    PMID: 26942764BACKGROUND

  • Schweitzer 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.

    PMID: 28964850BACKGROUND

  • Layden 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.

    PMID: 31491072BACKGROUND

  • Henry 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.

    PMID: 31491070BACKGROUND

  • Maddock 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.

    PMID: 31491073BACKGROUND

  • Davidson 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.

    PMID: 31513559BACKGROUND

  • Landman 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.

    PMID: 31753841BACKGROUND

  • Miller 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.

    PMID: 16055882BACKGROUND

  • Oostveen 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.

    PMID: 14680096BACKGROUND

  • Kirby 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.

    PMID: 22104288BACKGROUND

  • Owrangi 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.

    PMID: 23570935BACKGROUND

  • Pizzichini 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.

    PMID: 8756799BACKGROUND

  • McGavin CR, Artvinli M, Naoe H, McHardy GJ. Dyspnoea, disability, and distance walked: comparison of estimates of exercise performance in respiratory disease. Br Med J. 1978 Jul 22;2(6132):241-3. doi: 10.1136/bmj.2.6132.241.

    PMID: 678885BACKGROUND

  • Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.

    PMID: 19720809BACKGROUND

  • Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.

    PMID: 1595997BACKGROUND

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PMID: 12900694BACKGROUND

MeSH Terms

Conditions

Vaping

Interventions

Tomography, X-Ray ComputedRespiratory Function TestsExercise TestHematologic TestsSurveys and Questionnaires

Condition Hierarchy (Ancestors)

SmokingBehavior

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomographyDiagnostic Techniques, Respiratory SystemHeart Function TestsDiagnostic Techniques, CardiovascularErgometryInvestigative TechniquesClinical Laboratory TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Grace E Parraga

    Western University - Robarts Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace E Parraga, PhD

CONTACT

519-931-5265gparraga@robarts.ca

Angela Wilson, RRT

CONTACT

519-931-5777awilson@robarts.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Scientist. Robarts Research Institute

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 4, 2020

Study Start

January 17, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)