NCT04881942

Characterization of Selected Aerosol Constituents Levels in the Exhaled Breath of Adult e-Vapor Users

Completed NA Results posted Last updated 30 July 2024

What this trial tests

NA trial testing e-Vapor Product A in Tobacco Use in 35 participants. Completed in 26 January 2018.

Timeline

27 March 2017

Primary endpoint
21 April 2017

26 January 2018

Quick facts

Lead sponsor	Altria Client Services LLC
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	35
Start date	27 March 2017
Primary completion	21 April 2017
Estimated completion	26 January 2018
Sites	1 location across United States

Drugs / interventions tested

• e-Vapor Product A
• e-Vapor Product B
• e-Vapor Product C
• e-Vapor Product D

Conditions studied

• Tobacco Use — all drugs for Tobacco Use →

Sponsor

Altria Client Services LLC — full company profile →

Who can join

Adults 21 to 65, any sex, with Tobacco Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Nicotine Residue Summary Statistics by Test-Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping cont

Group	Value	95% CI
e-Vapor Product A	87.1	± 120.11
e-Vapor Product B	192.3	± 268.53
e-Vapor Product C	174.1	± 208.64
e-Vapor Product D	182.8	± 253.88

Sham Nicotine Residue Summary Statistics by Test-Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping containe

Group	Value	95% CI
e-Vapor Product A	0.9	± 0.66
e-Vapor Product B	0.9	± 0.66
e-Vapor Product C	0.9	± 0.70
e-Vapor Product D	0.9	± 0.69

Total Sham-Corrected Nicotine Summary Statistics by Test Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery \& empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge \& inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into

Group	Value	95% CI
e-Vapor Product A	86.1	± 120.40
e-Vapor Product B	191.4	± 268.78
e-Vapor Product C	173.1	± 208.93
e-Vapor Product D	181.8	± 254.23

Glycerin Residue Summary Statistics by Test-Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping cont

Group	Value	95% CI
e-Vapor Product A	5964.4	± 5029.33
e-Vapor Product B	5707.3	± 5015.41
e-Vapor Product C	6516.6	± 5387.80
e-Vapor Product D	5682.4	± 5156.04

Sham Glycerin Residue Summary Statistics by Test-Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping containe

Group	Value	95% CI
e-Vapor Product A	15.4	± 16.49
e-Vapor Product B	11.1	± 5.01
e-Vapor Product C	15.4	± 16.53
e-Vapor Product D	10.9	± 2.65

Total Sham-Corrected Glycerin Summary Statistics by Test Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery \& empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge \& inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into

Group	Value	95% CI
e-Vapor Product A	5949.0	± 5033.63
e-Vapor Product B	5696.2	± 5015.99
e-Vapor Product C	6501.2	± 5385.54
e-Vapor Product D	5671.5	± 5155.84

Menthol Residue Summary Statistics by Test-Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping cont

Group	Value	95% CI
e-Vapor Product A	0.4	± 0.13
e-Vapor Product B	0.4	± 0.08
e-Vapor Product C	22.1	± 9.99
e-Vapor Product D	31.3	± 15.12

Sham Menthol Residue Summary Statistics by Test-Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping containe

Group	Value	95% CI
e-Vapor Product A	0.5	± 0.42
e-Vapor Product B	0.4	± 0.08
e-Vapor Product C	0.4	± 0.08
e-Vapor Product D	0.4	± 0.08

Total Sham-Corrected Menthol Summary Statistics by Test Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery \& empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge \& inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into

Group	Value	95% CI
e-Vapor Product A	-0.1	± 0.30
e-Vapor Product B	0.0	± 0.00
e-Vapor Product C	21.7	± 9.98
e-Vapor Product D	30.9	± 15.12

Propylene Glycol Residue Summary Statistics by Test-Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table summarizes the amount of analyte present in exhaled breath after test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping cont

Group	Value	95% CI
e-Vapor Product A	1697.6	± 2351.62
e-Vapor Product B	1047.7	± 1497.14
e-Vapor Product C	3343.4	± 4090.27
e-Vapor Product D	2675.8	± 3794.98

Sham Propylene Glycol Residue Summary Statistics by Test-Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table summarizes the amount of analyte present in exhaled breath after sham. The analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on the day the subject was assigned the indicated test product according to the randomization scheme. In the exhaled breath test product use session, one exhaled breath sample was collected using an empty cartridge and inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into the same type of trapping containe

Group	Value	95% CI
e-Vapor Product A	14.9	± 1.54
e-Vapor Product B	14.9	± 2.18
e-Vapor Product C	15.4	± 2.97
e-Vapor Product D	14.6	± 0.66

Total Sham-Corrected Propylene Glycol Summary Statistics by Test Product Group Primary · Data collected over an approximately 10-minute timeframe (2 consecutive exhaled breath samples of 5-minute durations each) on the day the subject was assigned to use the test product (Day 1 or Day 2 or Day 3 or Day 4 according to the randomization scheme)

Table presents difference in total analyte amount in exhaled breath samples between sham (inactive battery \& empty cartridge) and controlled test product use. Analyte was collected over an approximately 10-min collection period in the exhaled breath product use session on day the subject was assigned the indicated test product. In the exhaled breath test product use session, 1 exhaled breath sample was collected using an empty cartridge \& inactive battery \[sham condition\] followed by an exhaled breath sample using the test product. Each exhaled breath sample was collected separately into

Group	Value	95% CI
e-Vapor Product A	1682.7	± 2351.82
e-Vapor Product B	1032.8	± 1497.42
e-Vapor Product C	3328.0	± 4090.90
e-Vapor Product D	2661.2	± 3795.07

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Event (AE) data collected for entire study duration: approximately 34 days from Visit 1 (screening) through End of Study for each individual subject.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

e-Vapor Product A

Serious: 0/32 (0%)

Deaths: 0/32

e-Vapor Product B

Serious: 0/32 (0%)

Deaths: 0/32

e-Vapor Product C

Serious: 0/32 (0%)

Deaths: 0/32

e-Vapor Product D

Serious: 0/32 (0%)

Deaths: 0/32

Day -1 Product Trial Non-randomized Subjects

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (9 terms — click to expand)

Reaction	System	e-Vapor Product A	e-Vapor Product B	e-Vapor Product C	e-Vapor Product D	Day -1 Product Trial Non-r…
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Oral Discomfort	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT04881942 adverse events section.

Sponsor's own description

This is an open-label, 4-way crossover study designed to estimate the nicotine, glycerin, propylene glycol, menthol, formaldehyde, acetaldehyde, and acrolein levels in exhaled breath samples during use of four MarkTen® XL e-vapor products. The study will enroll approximately 32 adult e-vapor-using subjects at one site in the United States in High Point, NC.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Computational modeling method to estimate secondhand exposure potential from exhalations during e-vapor product use under various real-world scenarios.
   Edmiston JS, Rostami AA, Liang Q, Miller S, et al · · 2022 · cited 1× · PMID 36050572 · DOI 10.1007/s11739-022-03061-2