Clinical trial NCT05239793: Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects
Official title: Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cigarettes per day
timeFrame: 3 months
measure: Number of exacerbations
timeFrame: 3 months
Secondary outcomes:
measure: Lung function tests (spirometry)
timeFrame: 3 months
measure: COPD Assessment Test (CAT) scores
timeFrame: 3 months
measure: 6-min walk distance (6MWD)
timeFrame: 3 months
measure: Tobacco exposure
timeFrame: 3 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Health Hershey Medical Center
name: Rebecca Bascom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State Health Hershey Medical Center
name: Raghu Sinha, PhD
role: PRINCIPAL_INVESTIGATOR
References: