Effects of Electronic Cigarette Use on the Lungs

NCT02596685 | Completed DMC

• 2 other identifiers: OSU-15098NCI-2015-00842
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline to 5 weeks

Study Arms (4)

Arm A (electronic-cigarette)

EXPERIMENTAL

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.

Procedure: Bronchoscopy; Other: Electronic Cigarette; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm B (control)

EXPERIMENTAL

Patients receive no intervention. Patients undergo a second bronchoscopy during week 5.

Procedure: Bronchoscopy; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm I (bronchoscopy of the left lung)

EXPERIMENTAL

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

Procedure: Bronchoscopy; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm II (bronchoscopy of the right lung)

EXPERIMENTAL

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

Procedure: Bronchoscopy; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Interventions

Bronchoscopy PROCEDURE

Undergo bronchoscopy

Arm A (electronic-cigarette); Arm B (control); Arm I (bronchoscopy of the left lung); Arm II (bronchoscopy of the right lung)

Electronic Cigarette OTHER

Given nicotine-free and flavor-free electronic cigarettes

Also known as: e-Cigarette, Electronic Nicotine Delivery System

Arm A (electronic-cigarette)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (electronic-cigarette); Arm B (control); Arm I (bronchoscopy of the left lung); Arm II (bronchoscopy of the right lung)

Questionnaire Administration OTHER

Ancillary studies

Arm A (electronic-cigarette); Arm B (control); Arm I (bronchoscopy of the left lung); Arm II (bronchoscopy of the right lung)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 40394619 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Bronchoscopy; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Peter Shields, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: November 4, 2015
• Study Start: December 8, 2015
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)