Trial Outcomes & Findings for E-cigarettes for Harm Reduction in Adults With Asthma (NCT NCT05278065)
NCT ID: NCT05278065
Last Updated: 2025-11-18
Results Overview
Assessed using spirometry and indexed in liters.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
Electronic Cigarette
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
5
|
|
Overall Study
Completed Primary Outcome Visit
|
11
|
5
|
|
Overall Study
COMPLETED
|
11
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Electronic Cigarette
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
E-cigarettes for Harm Reduction in Adults With Asthma
Baseline characteristics by cohort
| Measure |
Electronic Cigarette
n=12 Participants
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
n=5 Participants
Participants in this assessment-only condition will continue smoking as usual.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
|
Age, Continuous
|
48.25 years
STANDARD_DEVIATION 11.7 • n=202 Participants
|
57.20 years
STANDARD_DEVIATION 5.26 • n=283 Participants
|
50.88 years
STANDARD_DEVIATION 10.90 • n=120 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
9 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=202 Participants
|
3 Participants
n=283 Participants
|
8 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
3 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
10 Participants
n=120 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
17 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8, Week 16Population: 1 participant withdrew from the study between baseline and week 8
Past week average cigarettes per day assessed using timeline follow-back (TLFB).
Outcome measures
| Measure |
Electronic Cigarette
n=12 Participants
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
n=5 Participants
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Change in Cigarettes Per Day From Baseline to Week 8 and Week 16
Baseline
|
16.34 cigarettes per day
Standard Deviation 8.68
|
15.39 cigarettes per day
Standard Deviation 6.43
|
|
Change in Cigarettes Per Day From Baseline to Week 8 and Week 16
Week 8
|
9.51 cigarettes per day
Standard Deviation 11.06
|
8.66 cigarettes per day
Standard Deviation 6.83
|
|
Change in Cigarettes Per Day From Baseline to Week 8 and Week 16
Week 16
|
8.12 cigarettes per day
Standard Deviation 7.06
|
12.30 cigarettes per day
Standard Deviation 10.00
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 1 participant withdrew from the study between baseline and week 8
Assessed using the Fagerstrom Test for Cigarette Dependence (FTCD). Range: 0-10; higher scores = more dependent.
Outcome measures
| Measure |
Electronic Cigarette
n=12 Participants
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
n=5 Participants
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Change in Cigarette Dependence From Baseline to Week 8
Baseline
|
5.08 score on a scale
Standard Deviation 2.68
|
5.60 score on a scale
Standard Deviation 2.19
|
|
Change in Cigarette Dependence From Baseline to Week 8
Week 8
|
4.73 score on a scale
Standard Deviation 2.33
|
5.60 score on a scale
Standard Deviation 0.89
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 1 participant withdrew from the study between baseline and week 8
Assessed using the Wisconsin Inventory for Smoking Dependence Motives - Brief (Brief-WISDM). The value of this outcome variable is the TOTAL SCORE (possible range: 1-7). The TOTAL SCORE is computed as a MEAN of all subscale scores (possible range: 1-7). Each subscale score is the mean of the relevant item scores (possible range: 1-7). Only the TOTAL SCORE is being investigated as an outcome measure. HIGHER SCORES = STRONGER dependence motive.
Outcome measures
| Measure |
Electronic Cigarette
n=12 Participants
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
n=5 Participants
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Change in Cigarette Dependence Motives From Baseline to Week 8
Baseline
|
4.79 score on a scale
Standard Deviation 0.96
|
5.41 score on a scale
Standard Deviation 1.69
|
|
Change in Cigarette Dependence Motives From Baseline to Week 8
Week 8
|
4.36 score on a scale
Standard Deviation 1.56
|
4.18 score on a scale
Standard Deviation 2.15
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 1 participant withdrew from the study between baseline and week 8
Assessed using the Asthma Symptom Utility Index (ASUI). Range: 0-1 continuous; higher scores = fewer or lighter symptoms (0 = worst possible symptoms, 1 = no symptoms).
Outcome measures
| Measure |
Electronic Cigarette
n=12 Participants
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
n=5 Participants
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Change in Asthma Symptoms From Baseline to Week 8
Week 8
|
0.61 score on a scale
Standard Deviation 0.21
|
0.69 score on a scale
Standard Deviation 0.23
|
|
Change in Asthma Symptoms From Baseline to Week 8
Baseline
|
0.71 score on a scale
Standard Deviation 0.18
|
0.65 score on a scale
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 1 participant withdrew from the study between baseline and week 8
Assessed using spirometry and indexed in liters.
Outcome measures
| Measure |
Electronic Cigarette
n=12 Participants
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
n=5 Participants
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV])
Baseline
|
2.24 liters
Standard Deviation 0.84
|
2.41 liters
Standard Deviation 0.53
|
|
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV])
Week 8
|
2.32 liters
Standard Deviation 0.93
|
2.30 liters
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 1 participant withdrew from the study between baseline and week 8
Assessed using spirometry and indexed in liters.
Outcome measures
| Measure |
Electronic Cigarette
n=12 Participants
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
n=5 Participants
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC])
Baseline
|
3.02 liters
Standard Deviation 1.00
|
3.35 liters
Standard Deviation 0.79
|
|
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC])
Week 8
|
3.13 liters
Standard Deviation 1.16
|
2.98 liters
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 1 participant withdrew from the study between baseline and week 8
Assessed using spirometry and indexed as liters per section (L/s).
Outcome measures
| Measure |
Electronic Cigarette
n=12 Participants
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
n=5 Participants
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75])
Baseline
|
1.91 liters per second (L/s)
Standard Deviation 1.00
|
1.82 liters per second (L/s)
Standard Deviation 0.87
|
|
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75])
Week 8
|
1.88 liters per second (L/s)
Standard Deviation 0.98
|
2.12 liters per second (L/s)
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 1 participant withdrew from the study between baseline and week 8
Assessed using spirometry and indexed in liters per minute (L/min).
Outcome measures
| Measure |
Electronic Cigarette
n=12 Participants
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
n=5 Participants
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF])
Baseline
|
6.50 liters per minute (L/min)
Standard Deviation 2.57
|
6.45 liters per minute (L/min)
Standard Deviation 1.41
|
|
Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF])
Week 8
|
6.68 liters per minute (L/min)
Standard Deviation 2.91
|
5.69 liters per minute (L/min)
Standard Deviation 1.69
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 1 participant withdrew from the study between baseline and week 8
Level of exhaled FENO assessed with NIOX breath sensor in parts per billion (PPB).
Outcome measures
| Measure |
Electronic Cigarette
n=12 Participants
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
n=5 Participants
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8
Baseline
|
11.6 parts per billion (PPB)
Standard Deviation 10.2
|
9.80 parts per billion (PPB)
Standard Deviation 8.01
|
|
Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8
Week 8
|
10.9 parts per billion (PPB)
Standard Deviation 8.96
|
7.75 parts per billion (PPB)
Standard Deviation 2.36
|
Adverse Events
Electronic Cigarette
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Smoking As Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Electronic Cigarette
n=12 participants at risk
Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
|
Smoking As Usual
n=5 participants at risk
Participants in this assessment-only condition will continue smoking as usual.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Irritation from e-cigarette vapor
|
8.3%
1/12 • Number of events 1 • Entire 8 week experimental and 8 week follow-up period (16 weeks
Adverse changes in medical status were assessed weekly during the experimental period (baseline - wk 8) and again at the final follow-up visit (wk 16)
|
0.00%
0/5 • Entire 8 week experimental and 8 week follow-up period (16 weeks
Adverse changes in medical status were assessed weekly during the experimental period (baseline - wk 8) and again at the final follow-up visit (wk 16)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place