Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

Penn State Health

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: NJOY e-cigarette

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05239793

1R01HL152436 (U.S. NIH Grant/Contract)

STUDY00015514

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

NJOY e-cigarette

Other group

Description:

NJOY e-cigarette containing 5% nicotine strength pods

Treatment:

Drug: NJOY e-cigarette