E-cigarettes for Harm Reduction in Adults With Asthma (NCT05278065) | Clinical Trial Compass
CompletedNot Applicable
E-cigarettes for Harm Reduction in Adults With Asthma
United States17 participantsStarted 2022-05-01
Plain-language summary
Smoking is the main cause of preventable disease and death in the US and impacts respiratory illnesses including COPD and asthma. However, little is known about the effects on smoking and lung health of substituting cigarettes with ENDS in adults with asthma. This project aims to test whether providing ENDS to adults with asthma will lead to substitution of smoking for ENDS, reduced dependence, and improved lung function so such knowledge can inform interventions to reduce the public health burden of tobacco.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female (50%), 21 to 65 (inclusive) years of age;
* Persistent asthma symptoms (i.e., episodic symptoms of airflow obstruction / airway hyperresponsiveness (AHR) as documented in review of medical history);
* Currently prescribed SABA medication;
* Past-year smoking of ≥5 cigarettes/day;
* Exhaled CO ≥ 6 ppm at baseline;
* Zero breath alcohol during informed consent for participation;
* English-speaking at an 8th grade level.
Exclusion Criteria:
* Intention to quit smoking during the next 30 days;
* Current engagement in any smoking cessation treatment;
* Current self-identification as regular ENDS user or using ENDS \> 2 days / week;
* Medical contraindication to nicotine;
* Pregnancy (due to toxicity of nicotine and tobacco products);
* Current alcohol dependence (AUDIT \> 15)
* Urine-screened or past-month self-reported use of illicit substances (amphetamine, cocaine, methamphetamine, opioids, benzodiazepines);
* Current psychosis, mania, or suicidal ideation;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Cigarettes Per Day From Baseline to Week 8 and Week 16
Timeframe: Baseline, Week 8, Week 16
2
Change in Cigarette Dependence From Baseline to Week 8
Timeframe: Baseline, Week 8
3
Change in Cigarette Dependence Motives From Baseline to Week 8
Timeframe: Baseline, Week 8
4
Change in Asthma Symptoms From Baseline to Week 8
Timeframe: Baseline, Week 8
5
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV])
Timeframe: Baseline, Week 8
6
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC])
Timeframe: Baseline, Week 8
7
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75])