E-cigarettes for COPD
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if switching from regular cigarettes to e-cigarettes can improve well-being and reduce harm in people with Chronic Obstructive Pulmonary Disease (COPD). Researchers believe that e-cigarettes might lessen COPD symptoms and decrease inflammation and stress in the body. The trial will test two e-cigarette brands, JUUL and NJOY, to assess their effects. It seeks smokers with mild to moderate COPD who are willing to reduce smoking by using e-cigarettes. As an Early Phase 1 trial, this study focuses on understanding how e-cigarettes affect COPD symptoms, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on antiarrhythmic drugs or medications to prevent seizures, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using e-cigarettes like NJOY might raise safety concerns, especially for people with COPD. Some studies have found that e-cigarette users are more likely to develop COPD than non-users, suggesting that e-cigarettes could worsen COPD symptoms for some individuals.
Conversely, other research suggests that e-cigarettes might help reduce certain breathing problems and pose only small risks to the lungs. This has led researchers to explore how switching from regular cigarettes to e-cigarettes might affect people with COPD.
While the evidence remains mixed, this early stage of research indicates that the safety of e-cigarettes for people with COPD is still under investigation. In clinical trials like this, researchers are beginning to understand how well people with COPD can tolerate these devices. Always consider discussing potential risks with a healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using e-cigarettes, like JUUL and NJOY, for COPD because they offer a smokeless alternative to traditional cigarettes. Unlike standard COPD treatments, which often include inhalers or medications that relax airway muscles or reduce inflammation, e-cigarettes aim to reduce harm by eliminating many harmful combustion byproducts found in cigarettes. The NJOY e-cigarette, specifically, delivers nicotine through 5% nicotine strength pods without the tar and other harmful chemicals of regular smoking. This could potentially help individuals with COPD reduce their cigarette consumption, possibly leading to fewer exacerbations and improved lung health.
What evidence suggests that e-cigarettes might be an effective treatment for COPD?
Research has shown that switching from regular cigarettes to e-cigarettes might reduce harm for some smokers with COPD. This trial will evaluate the effects of different e-cigarettes, including JUUL and NJOY, on COPD. Studies have indicated that quitting smoking is the best way to slow lung damage and the progression of COPD. Some evidence suggests that e-cigarettes can help people quit smoking completely. Although using e-cigarettes has been linked to a higher risk of COPD compared to not using them at all, they might still be less harmful than continuing to smoke regular cigarettes. Overall, while e-cigarettes are not without risks, they could be a safer option for smokers with COPD who want to quit.12678
Who Is on the Research Team?
Rebecca Bascom, MD
Principal Investigator
Penn State Health Hershey Medical Center
Raghu Sinha, PhD
Principal Investigator
Penn State Health Hershey Medical Center
Are You a Good Fit for This Trial?
This trial is for smokers with mild to moderate COPD who currently smoke a popular brand of cigarette and are willing to switch to using an e-cigarette. Participants must be able to give informed consent, attend study visits, read and write English, and agree to reduce their smoking by at least 25%. People with uncontrolled high blood pressure, drug or alcohol abuse history, allergies to e-cigarette ingredients, seizure disorders, recent heart issues or those pregnant/nursing cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants switch from cigarettes to NJOY e-cigarettes and are monitored for changes in COPD symptoms and biomarkers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JUUL e-cigarette
- NJOY e-cigarette
JUUL e-cigarette is already approved in United States, European Union, Canada for the following indications:
- Nicotine replacement therapy for smoking cessation
- Nicotine replacement therapy for smoking cessation
- Nicotine replacement therapy for smoking cessation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator