NCT04616313

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Western University, Canada · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• E Cigarette Use

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Hyperpolarized Xenon-129 MRI of the lungs	Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
DIAGNOSTIC_TEST	Computed Tomography (CT)	Participants will undergo a CT scan of the thoracic cavity
DIAGNOSTIC_TEST	Pulmonary Function Tests (PFT)	Participants will have their lung function evaluated using PFT
DIAGNOSTIC_TEST	Cardiopulmonary exercise testing (CPET)	Participants will perform cardiopulmonary exercise testing as a measure of exercise capacity
DIAGNOSTIC_TEST	Sputum analysis	Participants will provide a sputum sample that will be analysed for eosinophils
DIAGNOSTIC_TEST	Blood analysis	Participants will have their blood drawn and analysed for eosinophil count.
OTHER	Questionnaires	Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.

Timeline

• Start date: 2023-01-17
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2020-11-04
• Last updated: 2025-08-14

Locations

1 site across 1 country: Canada