Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

Early Phase 1Active Not RecruitingNCT05239793

Milton S. Hershey Medical Center30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

NJOY e-cigaretteDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Cigarettes per day

Self reported cigarettes per day

Time frame: 3 months

Number of exacerbations

Number of COPD exacerbations

Time frame: 3 months

Secondary Outcomes

Lung function tests (spirometry)

FEV1

Time frame: 3 months

COPD Assessment Test (CAT) scores

8-item scale with range of scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.

Time frame: 3 months

6-min walk distance (6MWD)

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

Time frame: 3 months

Tobacco exposure

Measure by cotinine (ng/ml)

Time frame: 3 months

Data from ClinicalTrials.gov

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