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.
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 Type
OBSERVATIONAL
Enrollment
150
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Participants will undergo a CT scan of the thoracic cavity
Participants will have their lung function evaluated using PFT
Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, Canada
RECRUITINGDetermine 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
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
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
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
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)
Time frame: 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)
Time frame: 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.
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Participants will perform cardiopulmonary exercise testing as a measure of exercise capacity
Participants will provide a sputum sample that will be analysed for eosinophils
Participants will have their blood drawn and analysed for eosinophil count.
Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
Measured using residual volume (RV)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 12 weeks following enrollment
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
Differences in airways between e-cigarette-only smokers and never smokers.
Measured using 129-Xe MRI
Time frame: 5 years
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
Differences in parenchyma between e-cigarette-only smokers and never smokers.
Measured using 129-Xe MRI
Time frame: 5 years
Changes in airways of e-cigarette smokers over time.
Measured using Xenon-129 (129-Xe) MRI
Time frame: 5 years
Changes in parenchyma of e-cigarette smokers over time.
Measured using Xenon-129 (129-Xe) MRI
Time frame: 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).
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FVC.
Measured using forced vital capacity (FVC)
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by TLC.
Measured using total lung capacity (TLC)
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FRC.
Measured using functional residual capacity (FRC)
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by RV.
Measured using residual volume (RV)
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FOT.
Measured using forced oscillation technique (FOT).
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by LCI.
Measured using lung clearance index (LCI)
Time frame: 5 years
Changes in lung function of e-cigarette smokers over time as measured by FeNO.
Measured using Fractional Exhaled Nitric Oxide (FeNO)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 5 years
Changes in lung health of e-cigarette smokers over time as measured by CAT.
Measured using the COPD assessment test (CAT)
Time frame: 5 years
Changes in lung health of e-cigarette smokers over time as measured by IPAQ.
Measured using the International Physical Activity Questionnaire (IPAQ).
Time frame: 5 years