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Novel Pulmonary Imaging of Lung Structure and Function in E-cigarette Smokers

ConditionE Cigarette Use
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorWestern University, Canada

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hyperpolarized Xenon-129 MRI of the lungs

    Diagnostic test

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

  • Computed Tomography (CT)

    Diagnostic test

    Participants will undergo a CT scan of the thoracic cavity

  • Pulmonary Function Tests (PFT)

    Diagnostic test

    Participants will have their lung function evaluated using PFT

  • Cardiopulmonary exercise testing (CPET)

    Diagnostic test

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

  • Sputum analysis

    Diagnostic test

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

  • Blood analysis

    Diagnostic test

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

  • Questionnaires

    Other intervention

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

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: c-cigarette never users7 interventions
Group B: former or current c-cigarette users7 interventions
Group C: never smokers7 interventions

Trial outcomes

Primary outcomes

1

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

Measured using 129-Xe MRI

Time frame
12 weeks following enrollment
2

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

Measured using computed tomography imaging

Time frame
12 weeks following enrollment
3

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)

Time frame
12 weeks following enrollment
4

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)

Time frame
12 weeks following enrollment

Secondary outcomes

1

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

Measured using 129-Xe MRI

Time frame
5 years
2

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

Measured using 129-Xe MRI

Time frame
5 years
3

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

Measured using 129-Xe MRI

Time frame
5 years
4

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

Measured using 129-Xe MRI

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Western University, Canada

Lead sponsor

London Health Sciences Centre

Collaborator

Source ClinicalTrials.gov
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