Effects of Electronic Cigarette Use on the Lungs

Tobacco Use Disorder Clinical Trial

Official title: Effects of Electronic Cigarette Use on the Human Lung

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Current Smoker
• E-cig User
• Former Smoker
• Never Smoker
• Tobacco Use Disorder

• NCT number: NCT02596685
• Study type: Interventional
• Source: Ohio State University Comprehensive Cancer Center
• Status: Completed
• Phase: N/A
• Start date: December 8, 2015
• Completion date: February 2, 2021