Impact of switching from cigarettes to e-cigarettes on COPD symptoms
Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects
EARLY_PHASE1 · Milton S. Hershey Medical Center · NCT05239793
This study is testing if switching from regular cigarettes to e-cigarettes can help people with COPD feel better and reduce their symptoms.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years to 74 Years |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center (other) |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT05239793 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates how switching from traditional cigarettes to electronic cigarettes (EC) affects clinical symptoms and biomarkers of harm in smokers with Chronic Obstructive Pulmonary Disease (COPD). The researchers hypothesize that participants who significantly reduce their cigarette use by adopting EC will experience fewer COPD symptoms, reduced exacerbation risks, and lower levels of oxidative stress and inflammation. The study aims to fill critical gaps in understanding the cardiopulmonary toxicity of EC-derived oxidants and their long-term effects on health. Participants will use NJOY e-cigarettes as part of the intervention.
Who should consider this trial
Good fit: Ideal candidates are smokers with mild to moderate COPD who are willing to significantly reduce their cigarette consumption.
Not a fit: Patients with a recent history of severe cardiac issues or those unwilling to change their smoking behavior may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of COPD symptoms and reduced health risks for smokers transitioning to e-cigarettes.
How similar studies have performed: While there is ongoing research into the effects of e-cigarettes, this specific approach focusing on COPD and oxidants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hershey, Pennsylvania
- Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Rebecca Bascom, MD — Penn State Health Hershey Medical Center
- Study coordinator: Timothy Sheehan
- Email: tsheehan@pennstatehealth.psu.edu
- Phone: 717-531-0003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Obstructive Pulmonary Disease