Chronic Obstructive Pulmonary Disease
Conditions
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 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
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.
Interventions
DRUGNJOY e-cigarette
NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarettes per day | 3 months | Self reported cigarettes per day |
| Number of exacerbations | 3 months | Number of COPD exacerbations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung function tests (spirometry) | 3 months | FEV1 |
| COPD Assessment Test (CAT) scores | 3 months | 8-item scale with range of scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. |
| 6-min walk distance (6MWD) | 3 months | This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. |
| Tobacco exposure | 3 months | Measure by cotinine (ng/ml) |
Countries
United States
Outcome results
None listed