This randomized pilot clinical trial studies the effects of electronic cigarettes on the lungs. Studying the effects of electronic cigarettes on the lungs may provide the Food and Drug Administration (FDA) and other government regulators with important information, which may help in developing future regulations to make electronic cigarettes safer.
PRIMARY OBJECTIVES: 1\) To conduct a pilot cross-sectional study of e-cig users (n=16), never-smokers (n=8 - completed under an earlier version of the protocol before never-smokers were used for Aim 2), (newly added n=15), former smokers who have quit smoking and are currently not using e-cigs (n=15), former smokers who switched to e-cigs (n=15) and smokers (n=16) \[total n=85), to better determine the influence of e-cig and smoking use (i.e., power) between never smokers and e-cig users, and to compare former smokers with e-cig use, and assessing use patterns and biomarkers by bronchoscopies using bronchioalveolar lavage (cell counts, inflammatory cytokines, untargeted metabolomics, and microbiome assessment), bronchial brushings (miRNA and mRNA expression, DNA methylation, acrolein DNA adducts, and mitochondrial DNA mutations and copy number variation), blood and urine to assess exposure to the e-cigs ingredients, saliva for oral microbiome assessment, and nasal brushing and nasal lavages for the lung toxicity as examined in this study as surrogate markers for the lung. We will also measure fractional exhaled nitric oxide (FeNO) as a marker of lower airway inflammation; and, 1a) Conduct a supplemental contamination study to measure if bacteria from oral cavity, nasal cavity or oropharynx may contaminate BAL fluid recovered during the bronchoscopy (n=30). Contamination analyses will measure if bacterial species found in oral cavity, nasal cavity and oropharynx are recovered in BAL. Contamination analyses will not examine differences between groups. 2\) To conduct a 4 week pilot clinical trial of nicotine-free and flavor-free e-cig use in never-smokers (n=30), randomized to e-cig use (n=15) or control (no e-cig use) (n=15), and assess biomarkers as in Aim 1 by bronchoscopy at baseline and at 4 weeks while on product (week 5 of trial). OUTLINE: PART I: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo bronchoscopy of the left lung over 30-60 minutes. ARM II: Patients undergo bronchoscopy of the right lung over 30-60 minutes. PART II: Patients who are never-smokers are then randomized to 1 of 2 arms. ARM A: Patients receive nicotine-free and flavor-free electronic cigarettes and instructed to use them twice daily (BID) over a 2 hour period for 4 weeks. ARM B: Patients receive no intervention. In both arms, patients undergo a second bronchoscopy during week 5.
Study Type
Undergo bronchoscopy
Given nicotine-free and flavor-free electronic cigarettes
Correlative studies
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Biomarker expression analysis to include cell counts
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
Time frame: Up to week 5
Biomarker expression analysis to include inflammatory cytokines (Part I)
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
Time frame: Up to week 5
Biomarker expression analysis to include untargeted metabolomics (Part I)
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
Time frame: Up to week 5
Biomarker expression analysis to include gene expression (Part I)
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
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INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
142
Ancillary studies
Time frame: Up to week 5
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (Part II)
Descriptive statistics and plots will be used to informally assess changes in biological parameters between bronchoscopies; repeated measures models may be used to control for possible confounding between the groups as well as provide estimates for future power calculations.
Time frame: Baseline to 5 weeks