Status:
ACTIVE_NOT_RECRUITING
Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
21-74 years
Phase:
EARLY_PHASE1
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 Obstructi...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05239793
Start Date
November 22 2022
End Date
June 30 2026
Last Update
October 27 2025
Active Locations (1)
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1
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033