Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: NJOY e-cigarette


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NJOY e-cigarette<br>NJOY e-cigarette containing 5% nicotine strength pods | Other: NJOY e-cigarette<br>* NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarettes per day | Self reported cigarettes per day | 12 months | 
| Number of exacerbations | Number of COPD exacerbations | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function tests (spirometry) | FEV1 | 12 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. | 12 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. | 12 months | 
| Tobacco exposure | Measure by cotinine (ng/ml) | 12 months |