Trial results for a study investigating e-cigarettes for harm reduction in adults with Asthma were posted on ClinicalTrials.gov on 2025-11-18. The study, which enrolled 17 participants, reported a mean reduction of 8.09 cigarettes per day (p=0.004) in the experimental arm at Week 8.
Background
Smoking is a major cause of preventable disease and death, significantly impacting respiratory illnesses such as asthma. While the health risks of traditional cigarettes are well-established, less is known about the effects of substituting cigarettes with Electronic Nicotine Delivery Systems (ENDS), or e-cigarettes, on smoking behaviors and lung health in adults with asthma. This knowledge gap highlights the need for research to inform strategies aimed at reducing the public health burden associated with tobacco use in this vulnerable population.
Trial design
This completed study, designated as Phase NA, enrolled 17 participants to investigate conditions including Smoking, Asthma, Electronic Cigarette Use, and Cigarette Smoking. The trial aimed to test whether providing ENDS to adults with asthma would lead to the substitution of smoking for ENDS, reduced dependence, and improved lung function. Participants were assigned to either an Electronic Cigarette group or a Smoking As Usual control group.
Key results
The trial reported several key measurements and analyses:
- Change in Cigarettes Per Day From Baseline to Week 8 and Week 16:
- For the Electronic Cigarette group, mean changes were observed at 16.34 (Standard Deviation 8.68), 9.51 (Standard Deviation 11.06), and 8.12 (Standard Deviation 7.06) cigarettes per day.
- For the Smoking As Usual group, mean changes were observed at 15.39 (Standard Deviation 6.43), 8.66 (Standard Deviation 6.83), and 12.30 (Standard Deviation 10.00) cigarettes per day.
- Change in Cigarette Dependence From Baseline to Week 8 (score on a scale):
- For the Electronic Cigarette group, mean changes were 5.08 (Standard Deviation 2.68) and 4.73 (Standard Deviation 2.33).
- For the Smoking As Usual group, mean changes were 5.60 (Standard Deviation 2.19) and 5.60 (Standard Deviation 0.89).
- Change in Cigarette Dependence Motives From Baseline to Week 8 (score on a scale):
- For the Electronic Cigarette group, a mean change of 4.79 (Standard Deviation 0.96) was observed.
- For the Smoking As Usual group, a mean change of 5.41 (Standard Deviation 1.69) was observed.
Key analyses revealed:
- A repeated measures analysis at Baseline and Week 8 for the experimental arm (Electronic Cigarette group) showed a mean difference of 8.09 (95.0% Confidence Interval: 3.2 to 12.98) in cigarettes per day, with a p-value of 0.004.
- The corresponding analysis for the control arm (Smoking As Usual group) showed a mean difference of 6.74 (95.0% Confidence Interval: -0.4 to 13.87) in cigarettes per day, with a p-value of 0.06.
- A repeated measures analysis at Week 8 and Week 16 for the experimental arm showed a mean difference of 1.39 (95.0% Confidence Interval: -3.41 to 6.19) in cigarettes per day, with a p-value of 0.533.
- The corresponding analysis for the control arm showed a mean difference of -3.69 (95.0% Confidence Interval: -12.21 to 4.84) in cigarettes per day, with a p-value of 0.296.
- A GEE analysis reported a slope of -0.932 with a p-value of 0.766.
- Another GEE analysis reported a slope of -5.075 with a p-value of 0.14.
What this means
The results suggest that for adults with asthma who smoke, the use of e-cigarettes may be associated with a significant reduction in the number of cigarettes smoked daily. Specifically, the experimental arm, which used e-cigarettes, demonstrated a statistically significant mean reduction of 8.09 cigarettes per day from baseline to Week 8. While the control group also showed a reduction, it did not reach statistical significance (p=0.06). These findings indicate a potential role for e-cigarettes in harm reduction strategies for this specific population, though further research is warranted to understand long-term effects and broader implications for lung health in individuals with asthma.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05278065, titled "E-cigarettes for Harm Reduction in Adults With Asthma", were posted on 2025-11-18 on clinicaltrials.gov.