Image

Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

Recruiting
21-74 years
All
Phase N/A

Powered by AI

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.

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

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

Study details
    Chronic Obstructive Pulmonary Disease

NCT05239793

Milton S. Hershey Medical Center

30 January 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.