Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects

This is a pilot study on the impact of switching from cigarettes to Electronic Cigarettes (EC) on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting Chronic Obstructive Pulmonary Disease (COPD). The researchers hypothesize that the smokers who switch to EC completely or significantly will experience reduced COPD symptoms, risks of exacerbations, and decreased levels of oxidative stress and inflammation.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: NJOY e-cigarette

Detailed Description

Smokers with COPD have a higher pack-year history and nicotine dependence compared to regular smokers as exemplified by the relatively large proportion of patients diagnosed with COPD that continue to smoke (95%).

This is a translational project which addresses the changing profile of tobacco product use in the United States (US) and the need for data regarding toxicity pathways for new nicotine products such as EC. In particular it focuses on critical scientific and clinically relevant gaps relating to oxidants in EC and their potential long-term cardiopulmonary effects. The study will obtain new information regarding the potential cardiopulmonary toxicity resulting from exposure to EC-derived oxidants that may lead to long-term disease development.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Mild to moderate COPD
• Smokes a popular brand of cigarette
• Willing to use an e-cigarette to reduce cigarette smoking down to 75% of their daily baseline cigarette use
• Ability to read, write and understand English
• Ability to provide informed consent and attend study visits

Exclusion Criteria:

• History of active, chronic drug abuse or alcohol abuse problems
• Actively changing smoking behavior
• Unwilling or unable to provide blood samples
• Pregnant, planning to become pregnant, or nursing
• Use of tobacco products other than cigarettes in the past 30 days
• Recent history (< 6 months) of myocardial infarction (MI)
• Any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or drug therapy within the past year. Antiarrhythmic drugs include amiodarone, flecainide, IV ibutilide, IV lidocaine, procainamide, propafenone, quinidine, tocainide
• Hospitalization for heart failure (NY Heart Association III or IV) within the past year
• Uncontrolled hypertension
• Known allergy to vegetable glycerin and propylene glycol
• History of seizures or medications to prevent seizures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NJOY e-cigarette; NJOY e-cigarette containing 5% nicotine strength pods	Drug: NJOY e-cigarette; NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarettes per day	Self reported cigarettes per day	3 months
Number of exacerbations	Number of COPD exacerbations	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function tests (spirometry)	FEV1	3 months
COPD Assessment Test (CAT) scores	8-item scale with range of scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.	3 months
6-min walk distance (6MWD)	This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.	3 months
Tobacco exposure	Measure by cotinine (ng/ml)	3 months

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Rebecca Bascom, MD, Penn State Health Hershey Medical Center; Principal Investigator: Raghu Sinha, PhD, Penn State Health Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Actual): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: October 23, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: STUDY00015514; 1R01HL152436 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We propose to make de-identified data, codebooks, documentation, and research protocols available to interested researchers after completion of the study.
• IPD Sharing Time Frame: Data will be available within 3 years of the culmination of data collection activities.
• IPD Sharing Access Criteria: Any investigator interested in collaboration or in using the data collected in this study for their own work will be invited to submit a 1-page abstract of their proposed research, including purpose, analytical plan, and dissemination plans. The study leadership team will review these proposals and decide on each based on the individual merits. Review criteria and prioritization of projects include: potential of the proposed work to advance public health, qualifications of the applicant, the potential for publication, the potential for future funding, and enhancing the scientific, geographic, and demographic diversity of the research portfolio.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No