Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

NCT05239793 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY000155141R01HL152436
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Cigarettes per day

  Self reported cigarettes per day

  3 months

• Number of exacerbations

  Number of COPD exacerbations

  3 months

Secondary Outcomes (4)

• Lung function tests (spirometry)

  3 months

• COPD Assessment Test (CAT) scores

  3 months

• 6-min walk distance (6MWD)

  3 months

• Tobacco exposure

  3 months

Study Arms (1)

NJOY e-cigarette

OTHER

NJOY e-cigarette containing 5% nicotine strength pods

Drug: NJOY e-cigarette

Interventions

NJOY e-cigarette DRUG

NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods

NJOY e-cigarette

Eligibility Criteria

• Age: 21 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rebecca Bascom, MD

  Penn State Health Hershey Medical Center

  PRINCIPAL INVESTIGATOR

• Raghu Sinha, PhD

  Penn State Health Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: November 22, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available within 3 years of the culmination of data collection activities.
• 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.

Locations

US (1)