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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities. [Срок оценки: 12 weeks following enrollment]
• Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities. [Срок оценки: 12 weeks following enrollment]
• Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FEV1. [Срок оценки: 12 weeks following enrollment]
• Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FVC. [Срок оценки: 12 weeks following enrollment]
• Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by TLC. [Срок оценки: 12 weeks following enrollment]
• Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FRC. [Срок оценки: 12 weeks following enrollment]
• Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by RV. [Срок оценки: 12 weeks following enrollment]
• Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FOT. [Срок оценки: 12 weeks following enrollment]
• Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by LCI. [Срок оценки: 12 weeks following enrollment]
• Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FeNO. [Срок оценки: 12 weeks following enrollment]

Вторичные конечные точки (12)

• Differences in airways between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers. [Срок оценки: 5 years]
• Differences in airways between e-cigarette-only smokers and never smokers. [Срок оценки: 5 years]
• Differences in parenchyma between e-cigarette-only smokers and both e-cigarette and c-cigarette smokers. [Срок оценки: 5 years]
• Differences in parenchyma between e-cigarette-only smokers and never smokers. [Срок оценки: 5 years]
• Changes in airways of e-cigarette smokers over time. [Срок оценки: 5 years]
• Changes in parenchyma of e-cigarette smokers over time. [Срок оценки: 5 years]
• Changes in lung function of e-cigarette smokers over time as measured by FEV1. [Срок оценки: 5 years]
• Changes in lung function of e-cigarette smokers over time as measured by FVC. [Срок оценки: 5 years]
• Changes in lung function of e-cigarette smokers over time as measured by TLC. [Срок оценки: 5 years]
• Changes in lung function of e-cigarette smokers over time as measured by FRC. [Срок оценки: 5 years]
• Changes in lung function of e-cigarette smokers over time as measured by RV. [Срок оценки: 5 years]
• Changes in lung function of e-cigarette smokers over time as measured by FOT. [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• Robarts Research Institute; The University of Western Ontario; London Health Sciences Cent — London

Публикации

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• Layden JE, Ghinai I, Pray I, Kimball A, Layer M, Tenforde MW, Navon L, Hoots B, Salvatore PP, Elderbrook M, Haupt T, Kanne J, Patel MT, Saathoff-Huber L, King BA, Schier JG, Mikosz CA, Meiman J. Pulmonary Illness Related to E-Cigarette Use in Illinois and Wisconsin - Final Report. N Engl J Med. 2020 Mar 5;382(10):903-916. doi: 10.1056/NEJMoa1911614. Epub 2019 Sep 6. PMID 31491072
• Henry TS, Kanne JP, Kligerman SJ. Imaging of Vaping-Associated Lung Disease. N Engl J Med. 2019 Oct 10;381(15):1486-1487. doi: 10.1056/NEJMc1911995. Epub 2019 Sep 6. No abstract available. PMID 31491070
• Maddock SD, Cirulis MM, Callahan SJ, Keenan LM, Pirozzi CS, Raman SM, Aberegg SK. Pulmonary Lipid-Laden Macrophages and Vaping. N Engl J Med. 2019 Oct 10;381(15):1488-1489. doi: 10.1056/NEJMc1912038. Epub 2019 Sep 6. No abstract available. PMID 31491073

Идентификаторы

NCT: NCT04616313 · ROB0048

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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