N/A N=17 Randomized Treatment

E-cigarettes for Harm Reduction in Adults With Asthma

Smoking · Asthma · Electronic Cigarette Use · Cigarette Smoking

Bottom Line

View on ClinicalTrials.gov: NCT05278065 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Change in Cigarettes Per Day From Baseline to Week 8 and Week 16 — 16.34; 15.39; 9.51; 8.66 cigarettes per day — p=.004

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nicotine (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Brown University
Primary completion: Sep 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Cigarettes Per Day From Baseline to Week 8 and Week 16	16.34; 15.39; 9.51; 8.66; 8.12; 12.30	.004 sig
PRIMARY Change in Cigarette Dependence From Baseline to Week 8	5.08; 5.60; 4.73; 5.60	.068
PRIMARY Change in Cigarette Dependence Motives From Baseline to Week 8	4.79; 5.41; 4.36; 4.18	.145
PRIMARY Change in Asthma Symptoms From Baseline to Week 8	0.71; 0.65; 0.61; 0.69	0.268
PRIMARY Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV])	2.24; 2.41; 2.32; 2.30	0.574
PRIMARY Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC])	3.02; 3.35; 3.13; 2.98	0.376
PRIMARY Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75])	1.91; 1.82; 1.88; 2.12	0.849
PRIMARY Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF])	6.50; 6.45; 6.68; 5.69	0.828
PRIMARY Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8	11.6; 9.80; 10.9; 7.75	0.965

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.

Eligibility Criteria

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;

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05278065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.