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E-Cigarettes for COPD

Phase 2
Waitlist Available
Led By Diann E Gaalema, PhD
Research Sponsored by University of Vermont
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 intake assessment
Awards & highlights

Study Summary

This trial studies whether vaping or smoking is healthier for people with lung disease.

Who is the study for?
This trial is for English-speaking adults over 40 in the Burlington, VT area who smoke daily and have no plans to quit soon. Participants must have a confirmed pulmonary disease like COPD, chronic bronchitis, emphysema, or asthma-COPD overlap syndrome. Those with recent medical instability or unable to perform home measurements cannot join.Check my eligibility
What is being tested?
The study aims to compare the effects of using e-cigarettes versus continuing regular smoking on lung and heart health in patients with existing lung diseases. It may also explore if financial incentives influence participants' choices regarding these options.See study design
What are the potential side effects?
Potential side effects from e-cigarette use could include throat irritation, coughing, shortness of breath, increased heart rate and blood pressure changes. The exact side effects will be studied as part of this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intake assessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and intake assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Chronic Obstructive Airway Disease
Baseline FEV1/FVC Ratio
Baseline Fractional Exhaled Nitric Oxide (FeNO)
+20 more
Secondary outcome measures
Baseline Blood Pressure
Baseline Heart Rate
Change From Baseline Heart Rate at 2 weeks
+5 more
Other outcome measures
Baseline Carbon Monoxide (CO)
Nicotine Dependence
Baseline Minnesota Tobacco Withdrawal Scale (MNWS)
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: E-CigaretteExperimental Treatment2 Interventions
Participants in this arm will smoke electronic cigarettes for two weeks. E-cigarettes (either JUUL or Vuse Alto) and pods (JUUL: Virginia tobacco flavor at 3% or 5% nicotine concentration; Vuse Alto: golden tobacco flavor at 1.8%, 2.4%, or 5% nicotine concentration) will be provided.
Group II: Combustible CigaretteActive Control1 Intervention
Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Financial Incentives
2018
Completed Phase 2
~11460

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
269 Previous Clinical Trials
3,743,754 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,483 Previous Clinical Trials
2,622,167 Total Patients Enrolled
Diann E Gaalema, PhDPrincipal InvestigatorUniversity of Vermont

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with using E-Cigarettes?

"Given the lack of Phase 3 data, our team at Power assigned a score of 2 to E-Cigarette in terms of safety. This is based on limited clinical evidence that suggests its security."

Answered by AI

Is this research endeavor currently accepting participants?

"Confirmed, clinicaltrials.gov's data shows this medical experiment is currently enrolling participants. Initially posted on April 28th 2022 and last amended November 3rd 2022, the trial requires 25 patients from a single site."

Answered by AI

How does this research aim to affect the medical world?

"This clinical trial will assess the change in fractional exhaled nitric oxide (FeNO) from baseline at two weeks. Secondary objectives include tracking changes to blood pressure, heart rate, and total arterial force over four weeks."

Answered by AI

How many patients are currently partaking in this medical research?

"Yes, the information on clinicaltrials.gov reveals that recruitment is in progress for this research trial which was first published on April 28th 2022. The most recent update to its details were made November 3rd of the same year and it seeks 25 participants from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
Diann Gaalema 2022. "Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05610514.
~7 spots leftby May 2025
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