Chronic Obstructive Pulmonary DiseaseEarly Phase 1NCT05239793
Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects
A Early Phase 1 study testing NJOY e-cigarette in people with Chronic Obstructive Pulmonary Disease, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 74 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- NJOY e-cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2022to 30 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- NJOY e-cigarette
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NJOY e-cigaretteDrug
NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods
| Study group | Role | What they receive |
|---|---|---|
| NJOY e-cigarette | Other | NJOY e-cigarette containing 5% nicotine strength pods Receives: Drug: NJOY e-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarettes per day
Self reported cigarettes per day
Measured: 3 months
Number of exacerbations
Number of COPD exacerbations
Measured: 3 months
Secondary outcomes (4)
Lung function tests (spirometry)
FEV1
Measured: 3 months
COPD Assessment Test (CAT) scores
8-item scale with range of scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: 3 months
6-min walk distance (6MWD)
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Measured: 3 months
Tobacco exposure
Measure by cotinine (ng/ml)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start22 Nov 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Rebecca Bascom, Penn State Health Milton S Hershey Medical Center
- Investigators
- Rebecca Bascom, MD, Principal investigator, Penn State Health Hershey Medical CenterRaghu Sinha, PhD, Principal investigator, Penn State Health Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239793
- Sponsor's protocol ID
- STUDY00015514
- Other IDs
- 1R01HL152436
- Status last verified
- Oct 2025
- First submitted
- 4 Feb 2022
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We propose to make de-identified data, codebooks, documentation, and research protocols available to interested researchers after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects
- ClinicalTrials.gov ID
- NCT05239793
- Acronym / sponsor ID
- STUDY00015514
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NJOY e-cigarette | Other | Drug: NJOY e-cigaretteNJOY e-cigarette containing 5% nicotine strength pods |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NJOY e-cigaretteNJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods | Drug | NJOY e-cigarette |
Primary outcome
Cigarettes per day
Time frame: 3 months
Self reported cigarettes per day
Number of exacerbations
Time frame: 3 months
Number of COPD exacerbations
4 secondary outcomes
Lung function tests (spirometry)
Time frame: 3 months
COPD Assessment Test (CAT) scores
Time frame: 3 months
6-min walk distance (6MWD)
Time frame: 3 months
Tobacco exposure
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Individual participant dataSharing planned: Yes. We propose to make de-identified data, codebooks, documentation, and research protocols available to interested researchers after completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Bascom, MD principal investigator
Penn State Health Hershey Medical Center
Raghu Sinha, PhD principal investigator
Penn State Health Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NJOY e-cigarette in people with Chronic Obstructive Pulmonary Disease, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarettes per day (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.