Trial Outcomes & Findings for Young Adult EC Use and Respiratory Outcomes (NCT NCT04395274)
NCT ID: NCT04395274
Last Updated: 2024-12-12
Results Overview
Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session.
COMPLETED
115 participants
Baseline, 3-month, 6-month, 9-month, 12-month
2024-12-12
Participant Flow
Participants are assigned to a study arm (Current E-Cigarette User or Never E-Cigarette/Tobacco User) after completion of the baseline survey. 10 Participants were found to be ineligible due to their tobacco use patterns reported at baseline, these participants were excluded from the study prior to being assigned to a study arm and are not included in the participant flow.
Participant milestones
| Measure |
Current E-Cigarette Users
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
Monitoring never users of any tobacco or e-cigarette products.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
|
Overall Study
3-month
|
26
|
46
|
|
Overall Study
6-month
|
19
|
36
|
|
Overall Study
9-month
|
12
|
34
|
|
Overall Study
12-month
|
19
|
31
|
|
Overall Study
COMPLETED
|
19
|
31
|
|
Overall Study
NOT COMPLETED
|
33
|
22
|
Reasons for withdrawal
| Measure |
Current E-Cigarette Users
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
Monitoring never users of any tobacco or e-cigarette products.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
11
|
|
Overall Study
Withdrawal by Subject
|
13
|
10
|
|
Overall Study
Moved Abroad
|
0
|
1
|
Baseline Characteristics
Young Adult EC Use and Respiratory Outcomes
Baseline characteristics by cohort
| Measure |
Current E-Cigarette Users
n=52 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=53 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.81 years
STANDARD_DEVIATION 2.11 • n=5 Participants
|
20.11 years
STANDARD_DEVIATION 2.01 • n=7 Participants
|
20.95 years
STANDARD_DEVIATION 2.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Days used e-cigarettes in past 30 days
|
26.38 days
STANDARD_DEVIATION 6.24 • n=5 Participants
|
0 days
STANDARD_DEVIATION 0 • n=7 Participants
|
13.07 days
STANDARD_DEVIATION 13.96 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: Only participants who were eligible at baseline and provided spirometry measurements are included. The number of participants at follow-up is less than that at baseline due to loss to follow-up over time.
Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session.
Outcome measures
| Measure |
Current E-Cigarette Users
n=780 Forced Expiratory Maneuvers
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=1235 Forced Expiratory Maneuvers
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)
Baseline
|
4.42 liter
Standard Deviation 1.30
|
3.54 liter
Standard Deviation 0.97
|
—
|
|
Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)
3-month
|
4.61 liter
Standard Deviation 1.70
|
3.68 liter
Standard Deviation 1.00
|
—
|
|
Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)
6-month
|
4.62 liter
Standard Deviation 1.66
|
3.96 liter
Standard Deviation 1.10
|
—
|
|
Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)
9-month
|
4.52 liter
Standard Deviation 1.26
|
3.89 liter
Standard Deviation 1.09
|
—
|
|
Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)
12-month
|
4.34 liter
Standard Deviation 1.45
|
4.33 liter
Standard Deviation 1.00
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: Only participants who were eligible at baseline and provided spirometry measurements are included. The number of participants at follow-up is less than that at baseline due to loss to follow-up over time.
Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session.
Outcome measures
| Measure |
Current E-Cigarette Users
n=780 Forced Expiratory Maneuvers
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=1235 Forced Expiratory Maneuvers
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV)
Baseline
|
3.63 Liters
Standard Deviation 0.93
|
3.04 Liters
Standard Deviation 0.70
|
—
|
|
Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV)
3-month
|
3.64 Liters
Standard Deviation 1.12
|
3.18 Liters
Standard Deviation 0.72
|
—
|
|
Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV)
6-month
|
3.67 Liters
Standard Deviation 1.15
|
3.36 Liters
Standard Deviation 0.83
|
—
|
|
Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV)
9-month
|
3.81 Liters
Standard Deviation 0.85
|
3.34 Liters
Standard Deviation 0.84
|
—
|
|
Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV)
12-month
|
3.60 Liters
Standard Deviation 0.96
|
3.63 Liters
Standard Deviation 0.82
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: Only participants who were eligible and using e-cigarettes at baseline are included. The number of participants at follow-up is less than that at baseline due to loss to follow-up over time.
Changes in product use evaluated with an evaluation of the changes in dependence using the Hooked on Nicotine Checklist (HONC). Scores range from 0 to 10 with higher values indicating greater levels of dependence.
Outcome measures
| Measure |
Current E-Cigarette Users
n=24 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=20 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
n=6 Participants
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Level of Dependence by Product Type Will be Examined.
Baseline
|
5.83 score on a scale
Standard Deviation 3.06
|
7.35 score on a scale
Standard Deviation 2.83
|
7.67 score on a scale
Standard Deviation 2.34
|
|
Level of Dependence by Product Type Will be Examined.
3-month
|
5.55 score on a scale
Standard Deviation 3.36
|
8.44 score on a scale
Standard Deviation 1.01
|
7.00 score on a scale
Standard Deviation 1.41
|
|
Level of Dependence by Product Type Will be Examined.
6-month
|
6.30 score on a scale
Standard Deviation 3.71
|
8.50 score on a scale
Standard Deviation 1.38
|
—
|
|
Level of Dependence by Product Type Will be Examined.
9-month
|
5.86 score on a scale
Standard Deviation 3.08
|
8.33 score on a scale
Standard Deviation 0.58
|
—
|
|
Level of Dependence by Product Type Will be Examined.
12-month
|
6.71 score on a scale
Standard Deviation 3.35
|
7.40 score on a scale
Standard Deviation 0.89
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine).
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=49 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - IL-6
Baseline
|
14.31 pg/mL
Standard Deviation 24.97
|
9.95 pg/mL
Standard Deviation 19.57
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-6
3-month
|
49.50 pg/mL
Standard Deviation 113.35
|
17.63 pg/mL
Standard Deviation 35.50
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-6
6-month
|
19.72 pg/mL
Standard Deviation 30.59
|
37.01 pg/mL
Standard Deviation 91.92
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-6
9-month
|
14.83 pg/mL
Standard Deviation 27.87
|
12.63 pg/mL
Standard Deviation 25.82
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-6
12-month
|
11.16 pg/mL
Standard Deviation 19.36
|
48.85 pg/mL
Standard Deviation 141.49
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=49 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - IL-8
Baseline
|
6637.06 pg/mL
Standard Deviation 10518.30
|
12872.08 pg/mL
Standard Deviation 23804.68
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-8
3-month
|
7630.32 pg/mL
Standard Deviation 13048.51
|
13890.15 pg/mL
Standard Deviation 21078.75
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-8
6-month
|
9509.56 pg/mL
Standard Deviation 18926.62
|
20161.25 pg/mL
Standard Deviation 57400.44
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-8
9-month
|
13648.62 pg/mL
Standard Deviation 17464.65
|
16718.97 pg/mL
Standard Deviation 20585.58
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-8
12-month
|
5071.09 pg/mL
Standard Deviation 5763.48
|
13701.80 pg/mL
Standard Deviation 22627.42
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=49 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - TNF-alpha
Baseline
|
5.86 pg/mL
Standard Deviation 6.87
|
4.98 pg/mL
Standard Deviation 5.07
|
—
|
|
Respiratory Health Measures by Nasal Swab - TNF-alpha
3-month
|
11.14 pg/mL
Standard Deviation 14.83
|
7.15 pg/mL
Standard Deviation 8.12
|
—
|
|
Respiratory Health Measures by Nasal Swab - TNF-alpha
6-month
|
6.53 pg/mL
Standard Deviation 5.32
|
6.25 pg/mL
Standard Deviation 6.31
|
—
|
|
Respiratory Health Measures by Nasal Swab - TNF-alpha
9-month
|
8.15 pg/mL
Standard Deviation 7.31
|
6.53 pg/mL
Standard Deviation 7.35
|
—
|
|
Respiratory Health Measures by Nasal Swab - TNF-alpha
12-month
|
6.31 pg/mL
Standard Deviation 6.81
|
11.52 pg/mL
Standard Deviation 26.98
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=49 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - IL-4
Baseline
|
0.46 pg/mL
Standard Deviation 1.48
|
0.12 pg/mL
Standard Deviation 0.17
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-4
3-month
|
0.34 pg/mL
Standard Deviation 0.41
|
0.38 pg/mL
Standard Deviation 1.08
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-4
6-month
|
0.12 pg/mL
Standard Deviation 0.16
|
0.23 pg/mL
Standard Deviation 0.26
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-4
9-month
|
0.19 pg/mL
Standard Deviation 0.23
|
0.21 pg/mL
Standard Deviation 0.25
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-4
12-month
|
0.13 pg/mL
Standard Deviation 0.16
|
0.32 pg/mL
Standard Deviation 0.49
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=49 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - IL-5
Baseline
|
7.45 pg/mL
Standard Deviation 24.78
|
0.64 pg/mL
Standard Deviation 1.61
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-5
3-month
|
8.10 pg/mL
Standard Deviation 24.75
|
0.58 pg/mL
Standard Deviation 1.43
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-5
6-month
|
2.40 pg/mL
Standard Deviation 5.13
|
1.79 pg/mL
Standard Deviation 7.11
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-5
9-month
|
1.12 pg/mL
Standard Deviation 1.51
|
0.48 pg/mL
Standard Deviation 0.97
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-5
12-month
|
1.29 pg/mL
Standard Deviation 1.87
|
6.16 pg/mL
Standard Deviation 15.55
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=49 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - IL-10
12-month
|
55.95 pg/mL
Standard Deviation 238.43
|
47.67 pg/mL
Standard Deviation 255.71
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-10
Baseline
|
3.17 pg/mL
Standard Deviation 14.95
|
0.75 pg/mL
Standard Deviation 0.86
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-10
6-month
|
2.10 pg/mL
Standard Deviation 4.12
|
46.13 pg/mL
Standard Deviation 250.36
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-10
9-month
|
0.91 pg/mL
Standard Deviation 1.14
|
0.90 pg/mL
Standard Deviation 1.25
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-10
3-month
|
16.73 pg/mL
Standard Deviation 70.79
|
1.41 pg/mL
Standard Deviation 2.11
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=49 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - IL-13
Baseline
|
14.68 pg/mL
Standard Deviation 14.63
|
13.13 pg/mL
Standard Deviation 9.31
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-13
3-month
|
16.94 pg/mL
Standard Deviation 11.52
|
16.02 pg/mL
Standard Deviation 14.30
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-13
6-month
|
14.02 pg/mL
Standard Deviation 9.01
|
14.28 pg/mL
Standard Deviation 10.80
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-13
9-month
|
20.17 pg/mL
Standard Deviation 13.70
|
15.49 pg/mL
Standard Deviation 13.59
|
—
|
|
Respiratory Health Measures by Nasal Swab - IL-13
12-month
|
13.70 pg/mL
Standard Deviation 11.85
|
19.25 pg/mL
Standard Deviation 18.24
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=49 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - TARC
Baseline
|
8.97 pg/mL
Standard Deviation 11.59
|
26.73 pg/mL
Standard Deviation 38.79
|
—
|
|
Respiratory Health Measures by Nasal Swab - TARC
3-month
|
16.88 pg/mL
Standard Deviation 24.04
|
41.36 pg/mL
Standard Deviation 83.93
|
—
|
|
Respiratory Health Measures by Nasal Swab - TARC
6-month
|
19.28 pg/mL
Standard Deviation 34.76
|
26.22 pg/mL
Standard Deviation 24.10
|
—
|
|
Respiratory Health Measures by Nasal Swab - TARC
9-month
|
17.37 pg/mL
Standard Deviation 22.86
|
26.11 pg/mL
Standard Deviation 22.82
|
—
|
|
Respiratory Health Measures by Nasal Swab - TARC
12-month
|
27.19 pg/mL
Standard Deviation 63.00
|
68.70 pg/mL
Standard Deviation 195.73
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=49 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - Eotaxin
Baseline
|
135.72 pg/mL
Standard Deviation 145.29
|
167.33 pg/mL
Standard Deviation 214.22
|
—
|
|
Respiratory Health Measures by Nasal Swab - Eotaxin
3-month
|
135.21 pg/mL
Standard Deviation 122.14
|
208.15 pg/mL
Standard Deviation 223.99
|
—
|
|
Respiratory Health Measures by Nasal Swab - Eotaxin
6-month
|
228.79 pg/mL
Standard Deviation 236.56
|
188.60 pg/mL
Standard Deviation 252.67
|
—
|
|
Respiratory Health Measures by Nasal Swab - Eotaxin
9-month
|
191.06 pg/mL
Standard Deviation 120.87
|
206.17 pg/mL
Standard Deviation 258.11
|
—
|
|
Respiratory Health Measures by Nasal Swab - Eotaxin
12-month
|
234.12 pg/mL
Standard Deviation 290.53
|
220.85 pg/mL
Standard Deviation 226.80
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=49 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - MCP-1
Baseline
|
198.65 pg/mL
Standard Deviation 186.20
|
228.50 pg/mL
Standard Deviation 205.86
|
—
|
|
Respiratory Health Measures by Nasal Swab - MCP-1
3-month
|
247.34 pg/mL
Standard Deviation 407.93
|
387.24 pg/mL
Standard Deviation 454.32
|
—
|
|
Respiratory Health Measures by Nasal Swab - MCP-1
6-month
|
316.92 pg/mL
Standard Deviation 274.02
|
289.26 pg/mL
Standard Deviation 254.87
|
—
|
|
Respiratory Health Measures by Nasal Swab - MCP-1
9-month
|
284.78 pg/mL
Standard Deviation 139.83
|
371.59 pg/mL
Standard Deviation 446.76
|
—
|
|
Respiratory Health Measures by Nasal Swab - MCP-1
12-month
|
255.77 pg/mL
Standard Deviation 193.15
|
299.07 pg/mL
Standard Deviation 308.34
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=49 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - MCP-4
Baseline
|
6.88 pg/mL
Standard Deviation 10.71
|
6.94 pg/mL
Standard Deviation 11.50
|
—
|
|
Respiratory Health Measures by Nasal Swab - MCP-4
3-month
|
5.94 pg/mL
Standard Deviation 7.21
|
7.79 pg/mL
Standard Deviation 10.28
|
—
|
|
Respiratory Health Measures by Nasal Swab - MCP-4
6-month
|
16.62 pg/mL
Standard Deviation 32.59
|
8.74 pg/mL
Standard Deviation 19.83
|
—
|
|
Respiratory Health Measures by Nasal Swab - MCP-4
9-month
|
9.79 pg/mL
Standard Deviation 9.46
|
6.27 pg/mL
Standard Deviation 10.51
|
—
|
|
Respiratory Health Measures by Nasal Swab - MCP-4
12-month
|
8.93 pg/mL
Standard Deviation 12.11
|
8.07 pg/mL
Standard Deviation 9.99
|
—
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 9-month, 12-monthPopulation: The population of participants who both attended their study visit and were able to provide a sample is analyzed. Note that not all participants provided a sample at all visits.
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Outcome measures
| Measure |
Current E-Cigarette Users
n=42 Participants
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=50 Participants
Monitoring never users of any tobacco or e-cigarette products.
|
Other Device Type Users
Current e-cigarette users who report a device other than a disposable or pod mod as being their main vaping device
|
|---|---|---|---|
|
Respiratory Health Measures by Nasal Swab - Cotinine
Baseline
|
156.56 ng/mL
Standard Deviation 162.53
|
0.09 ng/mL
Standard Deviation 0.13
|
—
|
|
Respiratory Health Measures by Nasal Swab - Cotinine
3-month
|
145.43 ng/mL
Standard Deviation 129.93
|
0.08 ng/mL
Standard Deviation 0.00
|
—
|
|
Respiratory Health Measures by Nasal Swab - Cotinine
6-month
|
146.15 ng/mL
Standard Deviation 165.97
|
0.09 ng/mL
Standard Deviation 0.08
|
—
|
|
Respiratory Health Measures by Nasal Swab - Cotinine
9-month
|
195.47 ng/mL
Standard Deviation 190.39
|
0.07 ng/mL
Standard Deviation 0.00
|
—
|
|
Respiratory Health Measures by Nasal Swab - Cotinine
12-month
|
163.56 ng/mL
Standard Deviation 233.97
|
6.83 ng/mL
Standard Deviation 37.63
|
—
|
Adverse Events
Current E-Cigarette Users
Never E-Cigarette / Tobacco Users
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Current E-Cigarette Users
n=52 participants at risk
Monitoring current e-cigarette users
|
Never E-Cigarette / Tobacco Users
n=53 participants at risk
Monitoring never users of any tobacco or e-cigarette products.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.5%
7/52 • 12 months
|
0.00%
0/53 • 12 months
|
|
General disorders
Sore or dry mouth and throat
|
9.6%
5/52 • 12 months
|
0.00%
0/53 • 12 months
|
|
General disorders
Headache
|
7.7%
4/52 • 12 months
|
0.00%
0/53 • 12 months
|
|
General disorders
Dizziness
|
3.8%
2/52 • 12 months
|
0.00%
0/53 • 12 months
|
|
General disorders
Sleepiness
|
5.8%
3/52 • 12 months
|
0.00%
0/53 • 12 months
|
|
General disorders
Sleeplessness
|
3.8%
2/52 • Number of events 3 • 12 months
|
0.00%
0/53 • 12 months
|
|
Cardiac disorders
Heart palpitations
|
1.9%
1/52 • 12 months
|
0.00%
0/53 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Breathing difficulties
|
5.8%
3/52 • Number of events 4 • 12 months
|
0.00%
0/53 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.8%
2/52 • 12 months
|
0.00%
0/53 • 12 months
|
|
General disorders
Shortness of breath
|
11.5%
6/52 • 12 months
|
0.00%
0/53 • 12 months
|
|
Immune system disorders
Allergies
|
1.9%
1/52 • 12 months
|
0.00%
0/53 • 12 months
|
|
General disorders
Chest Pain
|
1.9%
1/52 • 12 months
|
0.00%
0/53 • 12 months
|
|
General disorders
Nausea
|
3.8%
2/52 • 12 months
|
0.00%
0/53 • 12 months
|
|
General disorders
Throat tightness
|
1.9%
1/52 • 12 months
|
0.00%
0/53 • 12 months
|
Additional Information
Dr. Alayna Tackett
Ohio State University Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place