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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8, week 16 for reporting.

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 more

Side effects data

From 2014 Phase 4 trial • 127 Patients • NCT01400243

65%

Any nonserious adverse event

22%

Itchiness at Patch Site

16%

Nausea

Redness at patch site

Headache

Decreased appetite

Lucid dreams

Hot or sweating

Lightheadedness

100%

80%

60%

40%

20%

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor

456 Previous Clinical Trials

558,314 Total Patients Enrolled

4 Trials studying Smoking

114 Patients Enrolled for Smoking

National Institute of General Medical Sciences (NIGMS)NIH

269 Previous Clinical Trials

247,082 Total Patients Enrolled

Frequently Asked Questions

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

Is the cut-off age for enrolment into this clinical trial under 25 years?

"The trial is currently taking applicants who are younger than 65 and at least of legal age."

Answered by AI

How can I become a participant in this research project?

"The requirements for enrollment in this trial are asthma and an age between 21-65. The number of patients necessary to complete the research is 30."

Answered by AI

What is the sample size of individuals receiving treatment in this clinical experiment?

"Affirmative. Clinicaltrials.gov attests that this medical study, initially posted in May 1st 2022, is presently searching for 30 participants from one centre. The data was last updated on July 18th of the same year."

Answered by AI

Are there currently any open opportunities for patient involvement in this experiment?

"The details on clinicaltrials.gov demonstrate that this trial is still in search of participants, with the posting first appearing on May 1st 2022 and most recently being updated July 18th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

E-cigarettes for Harm Reduction in Adults With Asthma

Alexander Sokolovsky 2022. "E-cigarettes for Harm Reduction in Adults With Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05278065.

All > Pediatric Asthma > Asthma