Effects of Electronic Cigarette Use on the Lungs

NCT ID: NCT02596685

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-08
• Study Completion Date: 2021-02-02

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Arm A (electronic-cigarette)

Patients receive nicotine-free and flavor-free electronic cigarettes and instructed to use them BID over a 2 hour period for 4 weeks.

Patients undergo a second bronchoscopy during week 5.

Group Type: EXPERIMENTAL

Bronchoscopy

Intervention Type: PROCEDURE

Undergo bronchoscopy

Electronic Cigarette

Intervention Type: OTHER

Given nicotine-free and flavor-free electronic cigarettes

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm B (control)

Patients receive no intervention.

Patients undergo a second bronchoscopy during week 5.

Group Type: EXPERIMENTAL

Bronchoscopy

Intervention Type: PROCEDURE

Undergo bronchoscopy

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm I (bronchoscopy of the left lung)

Patients undergo bronchoscopy of the left lung over 30-60 minutes.

Group Type: EXPERIMENTAL

Bronchoscopy

Intervention Type: PROCEDURE

Undergo bronchoscopy

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm II (bronchoscopy of the right lung)

Patients undergo bronchoscopy of the right lung over 30-60 minutes.

Group Type: EXPERIMENTAL

Bronchoscopy

Intervention Type: PROCEDURE

Undergo bronchoscopy

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Bronchoscopy

Undergo bronchoscopy

Intervention Type: PROCEDURE

Electronic Cigarette

Given nicotine-free and flavor-free electronic cigarettes

Intervention Type: OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

e-Cigarette; Electronic Nicotine Delivery System

Eligibility Criteria

Inclusion Criteria

• Aim 1 only: 1) smokers who smoke at least 10 cigarettes per day with a stable smoking pattern of at least 6 months and no prior e-cig use within one year. Smoking status will be confirmed by salivary cotinine; subjects with at least 10 ng/ml cotinine in their saliva being considered smokers [150]. 2) e-cig users who report using e-cigs daily for 3 months with at least one nicotine-containing cartridge/day or 1 ml of liquid/day. They should have not smoked a cigarette for at least one year. 3) former smokers currently using nicotine-containing e-cigs who have completely switched to e-cigs 1-5 years earlier, and previously smoked >10 cigs/day for >1 year. 4) former-smokers who have quit smoking 1-5 years previously, and who previously smoked >10 cigs/day for >1 year and no e-cig use for a year and <10 days in their lifetime. 5) never-smokers who have smoked less than 100 cigarettes in their lifetime and not for at least 1 year, and not have used an e-cig for at least 1 year. Lack of regular smoking will be confirmed by NicAlert.
• Aim 2 only: Non-smokers who have smoked less than 100 cigarettes in their lifetime and not for at least 1 year, and not have used an e-cig for at least 1 year. Lack of regular smoking will be confirmed by salivary cotinine. Participants should be in good physical and mental health, particularly those randomized to the control condition;

Exclusion Criteria

• Able to read adequately to complete the survey and related study documents or give consent; and
• Subject has provided written informed consent to participate in the study.

• Immune system disorders, pulmonary diseases (e.g., asthma within the prior 5 years, acute bronchitis within 1 year, COPD, chronic bronchitis, and restrictive lung disease), clinically diagnosed kidney or liver diseases, or any other medical disorders that will increase the risk from bronchoscopy, affect biomarker data, or increase risk of an adverse effect from e-cig use. All subjects are screened by a pulmonologist obtaining a medical history and a physical examination (heart, lungs and oral cavity) to ensure no increased risk from bronchoscopy or e-cig use;
• General anesthesia within one year;
• Use of inhalant medications in the last 3 months;
• Use of antibiotics in prior 30 days;
• Use of steroids, including corticosteroids, in prior 30 days;
• Allergies to study medications, such as, lidocaine, Versed, Fentanyl or Cetacaine
• Bronchoscopy or any other lung procedure for any reason within the previous year;
• Current or recent (within three months) alcohol or drug abuse problems, including marijuana use within the last 30 days. Subjects with a positive Tetrahydrocannabinol (THC) strip test at any visit will be excluded;
• Other tobacco use (e.g., combustible products, vapors, etc.) within the last 3 months;
• Other tobacco use within the past year for 7 consecutive days or 14 times.
• Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product) or intention to quit in next three months;
• BMI > 40 (risk of unstable airway)
• Pregnant or breastfeeding in prior 3 months - If the subject is female, the investigator will provide a urine pregnancy test at no cost to the subject. The subject will take the pregnancy test before each bronchoscopy; and,
• Unable to read for comprehension or completion of study documents.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Peter Shields

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Shields, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

References

McElroy JP, Song MA, Barr JR, Gardner MS, Kinnebrew G, Kuklenyik Z, Kusovschi JD, Rees JC, Blount BC, Tsai M, Wewers MD, Kamel S, Reisinger SA, Singh A, Weng DY, Shields PG. Lung lipids associated with smoking and ECIG use in a cross-sectional study and clinical trial. Respir Res. 2025 May 20;26(1):193. doi: 10.1186/s12931-025-03267-w.

Reference Type: DERIVED

PMID: 40394619 (View on PubMed)

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2015-00842

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-15098

Identifier Type: -

Identifier Source: org_study_id