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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cigarettes per day
Number of exacerbations
Secondary outcome measures
6-min walk distance (6MWD)
COPD Assessment Test (CAT) scores
Lung function tests (spirometry)
+1 moreTrial 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
494 Previous Clinical Trials
2,798,812 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,827 Total Patients Enrolled
Rebecca Bascom, MDPrincipal InvestigatorPenn State Health Hershey Medical Center
2 Previous Clinical Trials
181 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly participants being accepted for this trial?
"Currently the trial is seeking out volunteers aged 21 to 65."
Answered by AI
What goals are being sought in this clinical experiment?
"The main objective of this 12-month trial is to monitor the number of exacerbations. Secondary measurements include cotinine levels, FEV1 values, and 6MWD results which measure the distance a participant can swiftly walk in six minutes on flat terrain."
Answered by AI
Who has been deemed qualified for this experiment?
"Eligibility criteria for this medical trial stipulate that participants must suffer from a chronic airflow obstruction and be between 21 to 65 years of age. Presently, approximately 30 patients are being recruited."
Answered by AI
What is the capacity of participants for this experimental program?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial has been actively recruiting since November 22nd 2022 and is currently searching for 30 patients from a single site."
Answered by AI
Are there still openings in this research endeavor?
"According to clinicaltrials.gov, the trial is currently recruiting participants. It was first announced on November 22nd 2022 and was recently updated a week later on November 29th."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
65+
What site did they apply to?
Penn State Health Milton S. Hershey Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I would like to see cures for diseases so someone may live a longer life without suffering.
PatientReceived 2+ prior treatments
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