Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05239793

Electronic Cigarette-derived Oxidants and 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NJOY e-cigarette

Drug

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

Primary outcomes

  1. Cigarettes per day

    Time frame: 3 months

    Self reported cigarettes per day

  2. Number of exacerbations

    Time frame: 3 months

    Number of COPD exacerbations

Secondary outcomes

  1. Lung function tests (spirometry)

    Time frame: 3 months

    FEV1

  2. COPD Assessment Test (CAT) scores

    Time frame: 3 months

    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. 6-min walk distance (6MWD)

    Time frame: 3 months

    This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.

  4. Tobacco exposure

    Time frame: 3 months

    Measure by cotinine (ng/ml)

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 15, 2022
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.