Trial Outcomes & Findings for In-vivo Effects of E-cigarette Aerosol on Innate Lung Host Defense (NCT NCT03700892)
NCT ID: NCT03700892
Last Updated: 2021-06-10
Results Overview
Absolute values of whole lung MCC at baseline compared to after CA vaping session. Absolute repeat values of Whole lung MCC = average % mucus cleared from the whole lung over a 90-minute period.
TERMINATED
NA
19 participants
Through study completion, an average of three months
2021-06-10
Participant Flow
After qualifying, all participants move to the baseline day in which an mucociliary clearance (MCC) scan and sputum are collected for baseline measurements. The vaping participants continue on to the crossover design for CA and PG/VG sessions followed by MCC scans and sputum collections for post exposure measurements.
Participant milestones
| Measure |
Cinnamaldehyde, Then PG/VG
Participants will inhale cinnamaldehyde(CA) e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour.
Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
PG/VG, Then Cinnamaldehyde
Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale cinnamaldehyde e-liquid in 6, 5-minute vaping segments (1 puff/minute) over 1 hour.
Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
Healthy Controls
Participants will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group.
|
|---|---|---|---|
|
Baseline
STARTED
|
15
|
0
|
4
|
|
Baseline
COMPLETED
|
15
|
0
|
4
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
|
First Intervention (Single 1-Day Visit)
STARTED
|
1
|
4
|
0
|
|
First Intervention (Single 1-Day Visit)
COMPLETED
|
1
|
4
|
0
|
|
First Intervention (Single 1-Day Visit)
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout (2-3 Weeks)
STARTED
|
1
|
4
|
0
|
|
Washout (2-3 Weeks)
COMPLETED
|
1
|
4
|
0
|
|
Washout (2-3 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention (Single 1-Day Visit)
STARTED
|
1
|
4
|
0
|
|
Second Intervention (Single 1-Day Visit)
Received Intervention
|
1
|
3
|
0
|
|
Second Intervention (Single 1-Day Visit)
COMPLETED
|
1
|
3
|
0
|
|
Second Intervention (Single 1-Day Visit)
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cinnamaldehyde, Then PG/VG
Participants will inhale cinnamaldehyde(CA) e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour.
Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
PG/VG, Then Cinnamaldehyde
Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale cinnamaldehyde e-liquid in 6, 5-minute vaping segments (1 puff/minute) over 1 hour.
Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
Healthy Controls
Participants will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group.
|
|---|---|---|---|
|
Second Intervention (Single 1-Day Visit)
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
In-vivo Effects of E-cigarette Aerosol on Innate Lung Host Defense
Baseline characteristics by cohort
| Measure |
All Treated Participants
n=15 Participants
All participants inhaled cinnamaldehyde e-liquid or Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in either Period 1 or Period 2 as per randomization schedule.
Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
Healthy Controls
n=4 Participants
Participants will only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of three monthsPopulation: The healthy control participants only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group. This Primary outcome does not apply to the healthy control group as they did not receive the intervention and only baseline data was collected.
Absolute values of whole lung MCC at baseline compared to after CA vaping session. Absolute repeat values of Whole lung MCC = average % mucus cleared from the whole lung over a 90-minute period.
Outcome measures
| Measure |
Cinnamaldehyde
n=4 Participants
Participants will inhale cinnamaldehyde e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.
Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
PG/VG
n=5 Participants
Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.
PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
|---|---|---|
|
CA-induced Changes in Whole Lung MCC
|
41 percent clearance
Standard Deviation 5
|
27 percent clearance
Standard Deviation 17
|
SECONDARY outcome
Timeframe: Through study completion, an average of three monthsAbsolute repeat values of Central and Peripheral lung MCC = average % mucus cleared from the Central and Peripheral lung over a 90-minute period. This will assess clearance rates from the central (C) and peripheral (P) regions as secondary endpoints that may reflect differential effects between a region with relatively more (C) vs. less (P) large bronchial airways.
Outcome measures
| Measure |
Cinnamaldehyde
n=4 Participants
Participants will inhale cinnamaldehyde e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.
Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
PG/VG
n=5 Participants
Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.
PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
|---|---|---|
|
CA-induced Changes in Regional Lung MCC
Peripheral Lung
|
33 percent clearance
Standard Deviation 3
|
24 percent clearance
Standard Deviation 6
|
|
CA-induced Changes in Regional Lung MCC
Central Lung
|
43 percent clearance
Standard Deviation 12
|
25 percent clearance
Standard Deviation 32
|
SECONDARY outcome
Timeframe: Through study completion, an average of three monthsPopulation: The healthy control participants only undergo the baseline testing and thus serve as a non-exposed/non-vaping control group. This outcome does not apply to the healthy control group as they did not receive the intervention and only baseline data was collected.
Percent change of PMNs in vapers from baseline compared to post CA vaping session. Percent change in PMNs in vapers from baseline compared to post PG/VG vaping session are included as an additional comparison.
Outcome measures
| Measure |
Cinnamaldehyde
n=4 Participants
Participants will inhale cinnamaldehyde e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.
Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
PG/VG
n=5 Participants
Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.
PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
|---|---|---|
|
Percent Polymorphonuclear Leukocytes (PMN) in Induced Sputum
|
3.6 percent PMN
Standard Error 7.2
|
89.4 percent PMN
Standard Error 5.8
|
SECONDARY outcome
Timeframe: Start of study, up to three monthsPopulation: Includes all participants who completed the baseline MCC scan.
Baseline Differences in Whole lung MCC clearance rates in Non-smokers/Non-vapers as Compared to E-cigarette Users. Absolute group values of Whole Lung MCC =average % mucus cleared from the whole lung over a 90-minute period.
Outcome measures
| Measure |
Cinnamaldehyde
n=15 Participants
Participants will inhale cinnamaldehyde e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.
Cinnamaldehyde e-liquid: Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
PG/VG
n=4 Participants
Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow.
PG/VG e-liquid: Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
|
|---|---|---|
|
Absolute Values of Whole Lung MCC for Each Group
|
17 percent clearance
Standard Deviation 8
|
14 percent clearance
Standard Deviation 6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsPercent change from baseline in phagocytosis
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsPercent change in cell counts as compared to baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsPercent change of mediator expression as compared to baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsPre-vaping session versus post-vaping session expressed as a percent change
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsPercent change as compared to post-vaping session sample
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsPercent change as compared to baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsTidal Volume in milliliters
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsRespiratory Rate in breaths per minute
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsMinute Ventilation in L/min
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsInspiratory flow in L/min
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsExpiratory flow in L/min
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsTidal Volume in milliliters
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsRespiratory Rate in breaths per minute
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsMinute Ventilation in L/min
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsInspiratory flow in L/min
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of three monthsExpiratory flow in L/min
Outcome measures
Outcome data not reported
Adverse Events
Cinnamaldehyde
PG/VG
Healthy Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Assistant Director of Clinical Research
University of North Carolina at Chapel Hill, Center for Environmental Medicine Asthma and Lung Biology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place