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E-cigarettes for Smoking Reduction in Adults with Asthma (SWAP Trial)
N/A
Recruiting
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently prescribed SABA medication;
Persistent asthma symptoms (i.e., episodic symptoms of airflow obstruction / airway hyperresponsiveness (AHR) as documented in review of medical history);
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8, week 16
Awards & highlights
SWAP Trial Summary
This trial will test whether adults with asthma who smoke cigarettes will substitute ENDS for cigarettes, reduce dependence, and improve lung function.
Who is the study for?
Adults aged 21-65 with persistent asthma symptoms who currently smoke at least 5 cigarettes a day can join this trial. They must have used short-acting bronchodilators, show signs of smoking on a breath test, and understand English well. People cannot participate if they've consumed alcohol during consent or don't meet other specific health criteria.Check my eligibility
What is being tested?
The study is testing whether using e-cigarettes (ENDS) helps adults with asthma switch from smoking regular cigarettes, become less dependent on nicotine, and improve their lung function. The goal is to see if e-cigarettes can reduce the harm caused by tobacco in people with respiratory issues.See study design
What are the potential side effects?
Possible side effects may include throat irritation, coughing, dry mouth or throat due to vaping; nicotine dependence; and potential unknown long-term impacts of using ENDS as an alternative to traditional cigarettes.
SWAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently taking medication for quick asthma relief.
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I have ongoing asthma symptoms.
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I am between 21 and 65 years old.
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I can speak and understand English at an 8th grade level.
SWAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8, week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8, week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 4 (Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) from baseline to week 8
Change in asthma control from baseline to week 8
Change in asthma symptom-related quality of life from baseline to week 8
+21 moreSide effects data
From 2014 Phase 4 trial • 127 Patients • NCT0140024365%
Any nonserious adverse event
22%
Itchiness at Patch Site
16%
Nausea
8%
Redness at patch site
5%
Headache
5%
Decreased appetite
2%
Lucid dreams
2%
Hot or sweating
2%
Lightheadedness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nicotine Patch
Placebo Patch
SWAP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Electronic cigaretteExperimental Treatment1 Intervention
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Group II: Smoking As UsualActive Control1 Intervention
Participants in this assessment-only condition will continue smoking as usual.
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Who is running the clinical trial?
Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,226 Total Patients Enrolled
4 Trials studying Smoking
103 Patients Enrolled for Smoking
National Institute of General Medical Sciences (NIGMS)NIH
271 Previous Clinical Trials
246,990 Total Patients Enrolled
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