E-cigarettes for COPD

Overseen By Timothy Sheehan

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Antiarrhythmics, Seizure medications

Disqualifiers: Drug abuse, Pregnancy, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

I have mild to moderate chronic obstructive pulmonary disease.

I have mild to moderate COPD.

Ability to provide informed consent and attend study visits

Exclusion Criteria

My blood pressure is not controlled by medication.

I have a history of seizures or take medication to prevent them.

I have used tobacco products other than cigarettes in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch from cigarettes to NJOY e-cigarettes and are monitored for changes in COPD symptoms and biomarkers

12 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JUUL e-cigarette
• NJOY e-cigarette

Trial Overview

The study tests if switching from regular cigarettes to NJOY e-cigarettes reduces symptoms of COPD and lowers the risk of exacerbations. It also looks at whether this switch decreases oxidative stress and inflammation in smokers with preexisting COPD.

How Is the Trial Designed?

Group I: NJOY e-cigarette Experimental Treatment 1 Intervention

NJOY e-cigarette containing 5% nicotine strength pods

JUUL e-cigarette is already approved in United States, European Union, Canada for the following indications:

Approved in United States as JUUL e-cigarette for:

• Nicotine replacement therapy for smoking cessation

Approved in European Union as JUUL e-cigarette for:

• Nicotine replacement therapy for smoking cessation

Approved in Canada as JUUL e-cigarette for:

• Nicotine replacement therapy for smoking cessation

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A study of five brands of electronic nicotine delivery systems (ENDS) revealed significant design flaws, including leaking cartridges and difficulty in handling without exposure to nicotine, raising safety concerns for users.

The labeling and instructions for ENDS were often inadequate and misleading, lacking essential safety information and proper disposal guidelines, suggesting a need for regulatory review before these products remain on the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems: is there a need for regulation? Trtchounian, A., Talbot, P.[2022]

Electronic nicotine delivery systems (ENDS) have evolved to become more sophisticated and efficient, potentially aiding in smoking cessation, but they also pose risks due to the inhalation of various compounds over time.

There is a need for more high-quality research to better understand the health effects and safety of ENDS, as well as their effectiveness in helping people quit smoking, especially given their increasing use for illicit drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems (ENDS): A convenient means of smoking? Sala, M., Gotti, C.[2023]

The entry of the JUUL electronic nicotine delivery system (ENDS) into the Canadian market was associated with a significant average decrease of 1.65% in cigarette sales per month, particularly in urban areas, indicating that JUUL may serve as a substitute for combustible cigarettes.

The study utilized a unique dataset from a major Canadian retailer and employed robust statistical methods to confirm that the availability of ENDS products like JUUL can effectively reduce local cigarette consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of JUUL market entry on cigarette sales: evidence from a major chain retailer in Canada. Xu, Y., Sen, A., Chen, T., et al.[2023]

In a study of 4909 adults who were established users of electronic nicotine delivery systems (ENDS), 9.8% reported having chronic obstructive pulmonary disease (COPD), with the highest prevalence (19.9%) among users of tobacco-flavored ENDS.

Tobacco-flavored ENDS were found to have a significantly higher association with self-reported COPD (adjusted odds ratio of 2.05) compared to non-tobacco flavors, suggesting a potential link between tobacco flavor use and respiratory health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of flavored electronic nicotine delivery system (ENDS) use with self-reported chronic obstructive pulmonary disease (COPD): Results from the Population Assessment of Tobacco and Health (PATH) study, Wave 4. Shi, H., Tavárez, ZQ., Xie, Z., et al.[2021]

Electronic nicotine delivery systems (ENDS), particularly JUUL, are being evaluated for their potential as smoking cessation tools, but their appeal to non-smokers raises public health concerns.

There is a need for clear definitions and well-controlled studies to understand the role of ENDS in harm reduction, as current metrics complicate conclusions about their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closing Perspective on the Special Issue on JUUL. Fagerström, KO.[2021]

In a study of 6,794 cigarette-only users, the cessation rates for electronic nicotine delivery systems (ENDS), nicotine replacement therapy (NRT), and non-NRT medications were found to be similar, with no significant differences in effectiveness (around 16% for ENDS and NRT, and 17.7% for non-NRT).

A concerning finding was that 37.6% of those who used ENDS to quit smoking became dual users of ENDS and cigarettes, highlighting the potential risk of continued nicotine dependence and the need for smokers to rely on FDA-approved cessation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of ENDS, NRT and medication for smoking cessation among cigarette-only users: a longitudinal analysis of PATH Study wave 3 (2015-2016) and 4 (2016-2017), adult data. Kaplan, B., Galiatsatos, P., Breland, A., et al.[2023]

The NJOY® King Bold Electronic Nicotine Delivery System (ENDS) effectively delivers nicotine, with blood levels increasing by an average of 3.5 ng/mL within 5 minutes of use, significantly reducing cravings by 55%.

During a one-week study with 25 adult smokers, participants reduced their cigarette consumption by 39%, indicating the potential of this ENDS for short-term smoking reduction or cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine blood levels and short-term smoking reduction with an electronic nicotine delivery system. Nides, MA., Leischow, SJ., Bhatter, M., et al.[2022]

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Studies suggest that ENDS use improves health outcomes, such as reducing respiratory symptoms, and presents only minimal respiratory risks.