Clinical trial NCT04616313: Novel Pulmonary Imaging of Lung Structure and Function in E-cigarette Smokers
Official title: Novel Pulmonary Imaging of Lung Structure and Function in Symptomatic and Asymptomatic E-cigarette Smokers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: E Cigarette Use
Keywords: e-cigarette smoking
pulmonary function
Xenon-129
Magnetic Resonance Imaging
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
First posted: 2020-11-04
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities.
timeFrame: 12 weeks following enrollment
measure: Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities.
timeFrame: 12 weeks following enrollment
measure: Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FEV1.
timeFrame: 12 weeks following enrollment
measure: Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FVC.
timeFrame: 12 weeks following enrollment
measure: Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by TLC.
timeFrame: 12 weeks following enrollment
measure: Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FRC.
timeFrame: 12 weeks following enrollment
measure: Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by RV.
timeFrame: 12 weeks following enrollment
measure: Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FOT.
timeFrame: 12 weeks following enrollment
measure: Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by LCI.
timeFrame: 12 weeks following enrollment
measure: Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FeNO.
timeFrame: 12 weeks following enrollment
measure: 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
timeFrame: 12 weeks following enrollment
Secondary outcomes:
measure: Differences in airways between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers.
timeFrame: 5 years
measure: Differences in airways between e-cigarette-only smokers and never smokers.
timeFrame: 5 years
measure: Differences in parenchyma between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers.
timeFrame: 5 years
measure: Differences in parenchyma between e-cigarette-only smokers and never smokers.
timeFrame: 5 years
measure: Changes in airways of e-cigarette smokers over time.
timeFrame: 5 years
measure: Changes in parenchyma of e-cigarette smokers over time.
timeFrame: 5 years
measure: Changes in lung function of e-cigarette smokers over time as measured by FEV1.
timeFrame: 5 years
measure: Changes in lung function of e-cigarette smokers over time as measured by FVC.
timeFrame: 5 years
measure: Changes in lung function of e-cigarette smokers over time as measured by TLC.
timeFrame: 5 years
measure: Changes in lung function of e-cigarette smokers over time as measured by FRC.
timeFrame: 5 years
measure: Changes in lung function of e-cigarette smokers over time as measured by RV.
timeFrame: 5 years
measure: Changes in lung function of e-cigarette smokers over time as measured by FOT.
timeFrame: 5 years
measure: Changes in lung function of e-cigarette smokers over time as measured by LCI.
timeFrame: 5 years
measure: Changes in lung function of e-cigarette smokers over time as measured by FeNO.
timeFrame: 5 years
measure: Changes in lung function of e-cigarette smokers over time as measured by exercise capacity.
timeFrame: 5 years
measure: Changes in lung health of e-cigarette smokers over time as measured by the mMRC dyspnea scale questionnaire.
timeFrame: 5 years
measure: Changes in lung health of e-cigarette smokers over time as measured by SGRQ.
timeFrame: 5 years
measure: Changes in lung health of e-cigarette smokers over time as measured by CAT.
timeFrame: 5 years
measure: Changes in lung health of e-cigarette smokers over time as measured by IPAQ.
timeFrame: 5 years
Other outcomes:
Locations:
city: London
country: Canada
facility: Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University - Robarts Research Institute
name: Grace E Parraga
role: PRINCIPAL_INVESTIGATOR
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