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Vaporizer
E-cigarettes for COPD
N/A
Recruiting
Led By Rebecca Bascom, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether e-cigarettes can help reduce symptoms and risks for smokers with COPD.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include throat irritation, coughing, dry mouth or increased nicotine dependence due to the use of NJOY e-cigarettes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cigarettes per day
Number of exacerbations
Secondary study objectives
6-min walk distance (6MWD)
COPD Assessment Test (CAT) scores
Lung function tests (spirometry)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NJOY e-cigaretteExperimental Treatment1 Intervention
NJOY e-cigarette containing 5% nicotine strength pods
Find a Location
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
508 Previous Clinical Trials
2,796,334 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,922 Previous Clinical Trials
47,760,716 Total Patients Enrolled
Rebecca Bascom, MDPrincipal InvestigatorPenn State Health Hershey Medical Center
2 Previous Clinical Trials
181 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is not controlled by medication.I have mild to moderate chronic obstructive pulmonary disease.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.I haven't had serious heart rhythm problems or needed heart rhythm drugs in the last year.I have not had a heart attack in the last 6 months.I have mild to moderate COPD.I smoke a popular brand of cigarettes.I have a history of chronic drug or alcohol abuse.I am willing to use an e-cigarette to cut down my smoking.I am allergic to vegetable glycerin and propylene glycol.I cannot or will not provide blood samples for the study.I was hospitalized for severe heart failure in the last year.I am currently trying to quit or reduce smoking.
Research Study Groups:
This trial has the following groups:- Group 1: NJOY e-cigarette
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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