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

Western University, Canada

Status: Enrolling

Conditions: E Cigarette Use

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

Study type: Observational

Funder types: Other

Identifiers

NCT04616313

ROB0048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

150 participants in 3 patient groups

c-cigarette never users

Description:

Includes 70 participants who are e-cigarette users who have never smoked combustible cigarettes.

Treatment:

Diagnostic Test: Pulmonary Function Tests (PFT)

Other: Questionnaires

Diagnostic Test: Cardiopulmonary exercise testing (CPET)

Diagnostic Test: Sputum analysis

Diagnostic Test: Computed Tomography (CT)

Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs

Diagnostic Test: Blood analysis

former or current c-cigarette users

Description:

Includes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers.

Treatment:

Diagnostic Test: Pulmonary Function Tests (PFT)

Other: Questionnaires

Diagnostic Test: Cardiopulmonary exercise testing (CPET)

Diagnostic Test: Sputum analysis

Diagnostic Test: Computed Tomography (CT)

Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs

Diagnostic Test: Blood analysis

never smokers

Description:

Includes 10 participants who have never smoked e-cigarettes or combustible cigarettes.

Treatment:

Diagnostic Test: Pulmonary Function Tests (PFT)

Other: Questionnaires

Diagnostic Test: Cardiopulmonary exercise testing (CPET)

Diagnostic Test: Sputum analysis

Diagnostic Test: Computed Tomography (CT)

Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs

Diagnostic Test: Blood analysis