E Cigarette Use
Conditions
Keywords
e-cigarette smoking, pulmonary function, Xenon-129, Magnetic Resonance Imaging
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.
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.
Interventions
DIAGNOSTIC_TESTHyperpolarized Xenon-129 MRI of the lungs
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
DIAGNOSTIC_TESTComputed Tomography (CT)
Participants will undergo a CT scan of the thoracic cavity
DIAGNOSTIC_TESTPulmonary Function Tests (PFT)
Participants will have their lung function evaluated using PFT
DIAGNOSTIC_TESTCardiopulmonary exercise testing (CPET)
Participants will perform cardiopulmonary exercise testing as a measure of exercise capacity
DIAGNOSTIC_TESTSputum analysis
Participants will provide a sputum sample that will be analysed for eosinophils
DIAGNOSTIC_TESTBlood analysis
Participants will have their blood drawn and analysed for eosinophil count.
OTHERQuestionnaires
Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
Sponsors
London Health Sciences Centre
Western University, Canada
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities. | 12 weeks following enrollment | Measured using 129-Xe MRI |
| Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FEV1. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 12 weeks following enrollment | Exercise capacity measured by cardio-pulmonary exercise testing (CPET) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in lung function of e-cigarette smokers over time as measured by RV. | 5 years | Measured using residual volume (RV) |
| Changes in lung function of e-cigarette smokers over time as measured by FOT. | 5 years | Measured using forced oscillation technique (FOT). |
| Changes in lung function of e-cigarette smokers over time as measured by LCI. | 5 years | Measured using lung clearance index (LCI) |
| Changes in lung function of e-cigarette smokers over time as measured by FeNO. | 5 years | Measured using Fractional Exhaled Nitric Oxide (FeNO) |
| Differences in airways between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers. | 5 years | Measured using 129-Xe MRI |
| Changes in lung health of e-cigarette smokers over time as measured by the mMRC dyspnea scale questionnaire. | 5 years | Measured using the modified medical research council (mMRC) dyspnea scale |
| Changes in lung health of e-cigarette smokers over time as measured by SGRQ. | 5 years | Measured using the St. George's respiratory questionnaire (SGRQ) |
| Changes in lung health of e-cigarette smokers over time as measured by CAT. | 5 years | Measured using the COPD assessment test (CAT) |
| Changes in lung health of e-cigarette smokers over time as measured by IPAQ. | 5 years | Measured using the International Physical Activity Questionnaire (IPAQ). |
| Changes in lung function of e-cigarette smokers over time as measured by exercise capacity. | 5 years | Exercise capacity measured by cardio-pulmonary exercise testing (CPET) |
| Differences in airways between e-cigarette-only smokers and never smokers. | 5 years | Measured using 129-Xe MRI |
| Differences in parenchyma between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers. | 5 years | Measured using 129-Xe MRI |
| Differences in parenchyma between e-cigarette-only smokers and never smokers. | 5 years | Measured using 129-Xe MRI |
| Changes in airways of e-cigarette smokers over time. | 5 years | Measured using Xenon-129 (129-Xe) MRI |
| Changes in parenchyma of e-cigarette smokers over time. | 5 years | Measured using Xenon-129 (129-Xe) MRI |
| Changes in lung function of e-cigarette smokers over time as measured by FEV1. | 5 years | Measured using forced expiratory volume in one second (FEV1). |
| Changes in lung function of e-cigarette smokers over time as measured by FVC. | 5 years | Measured using forced vital capacity (FVC) |
| Changes in lung function of e-cigarette smokers over time as measured by TLC. | 5 years | Measured using total lung capacity (TLC) |
| Changes in lung function of e-cigarette smokers over time as measured by FRC. | 5 years | Measured using functional residual capacity (FRC) |
Countries
Canada
Contacts
Primary ContactGrace E Parraga, PhD
Backup ContactAngela Wilson, RRT
Outcome results
None listed