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

Recruiting

• Conditions: E Cigarette Use
• Interventions: Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs; Diagnostic Test: Computed Tomography (CT); Diagnostic Test: Pulmonary Function Tests (PFT); Diagnostic Test: Cardiopulmonary exercise testing (CPET); Diagnostic Test: Sputum analysis; Diagnostic Test: Blood analysis; Other: Questionnaires

• Registration Number: NCT04616313
• Lead Sponsor: Western University, Canada

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.

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-04
• Study Start: 2023-01-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
c-cigarette never users	Hyperpolarized Xenon-129 MRI of the lungs	Includes 70 participants who are e-cigarette users who have never smoked combustible cigarettes.
c-cigarette never users	Sputum analysis	Includes 70 participants who are e-cigarette users who have never smoked combustible cigarettes.
c-cigarette never users	Blood analysis	Includes 70 participants who are e-cigarette users who have never smoked combustible cigarettes.
c-cigarette never users	Cardiopulmonary exercise testing (CPET)	Includes 70 participants who are e-cigarette users who have never smoked combustible cigarettes.
former or current c-cigarette users	Cardiopulmonary exercise testing (CPET)	Includes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers.
c-cigarette never users	Pulmonary Function Tests (PFT)	Includes 70 participants who are e-cigarette users who have never smoked combustible cigarettes.
former or current c-cigarette users	Hyperpolarized Xenon-129 MRI of the lungs	Includes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers.
former or current c-cigarette users	Computed Tomography (CT)	Includes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers.
never smokers	Pulmonary Function Tests (PFT)	Includes 10 participants who have never smoked e-cigarettes or combustible cigarettes.
never smokers	Sputum analysis	Includes 10 participants who have never smoked e-cigarettes or combustible cigarettes.
never smokers	Blood analysis	Includes 10 participants who have never smoked e-cigarettes or combustible cigarettes.
former or current c-cigarette users	Pulmonary Function Tests (PFT)	Includes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers.
never smokers	Questionnaires	Includes 10 participants who have never smoked e-cigarettes or combustible cigarettes.
c-cigarette never users	Computed Tomography (CT)	Includes 70 participants who are e-cigarette users who have never smoked combustible cigarettes.
c-cigarette never users	Questionnaires	Includes 70 participants who are e-cigarette users who have never smoked combustible cigarettes.
former or current c-cigarette users	Sputum analysis	Includes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers.
former or current c-cigarette users	Blood analysis	Includes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers.
former or current c-cigarette users	Questionnaires	Includes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers.
never smokers	Cardiopulmonary exercise testing (CPET)	Includes 10 participants who have never smoked e-cigarettes or combustible cigarettes.
never smokers	Hyperpolarized Xenon-129 MRI of the lungs	Includes 10 participants who have never smoked e-cigarettes or combustible cigarettes.
never smokers	Computed Tomography (CT)	Includes 10 participants who have never smoked e-cigarettes or combustible cigarettes.

Primary Outcome Measures

Name	Time	Method
Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities.	12 weeks following enrollment	Measured using computed tomography imaging
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 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 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 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 Outcome Measures

Name	Time	Method
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 RV.	5 years	Measured using residual volume (RV)
Changes in lung health of e-cigarette smokers over time as measured by CAT.	5 years	Measured using the COPD assessment test (CAT)
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 function of e-cigarette smokers over time as measured by FEV1.	5 years	Measured using forced expiratory volume in one second (FEV1).
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
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 health of e-cigarette smokers over time as measured by SGRQ.	5 years	Measured using the St. George's respiratory questionnaire (SGRQ)
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 FRC.	5 years	Measured using functional residual capacity (FRC)
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)
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 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)
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 health of e-cigarette smokers over time as measured by IPAQ.	5 years	Measured using the International Physical Activity Questionnaire (IPAQ).

Trial Locations

Locations (1)

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre; 🇨🇦 London, Ontario, Canada