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

NCT04881942 | Completed Results

• 1 other identifier: ALCS-RA-17-06-EV
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (21)

• Nicotine Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Sham Nicotine Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Total Sham-Corrected Nicotine Summary Statistics by Test Product Group

  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 the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Glycerin Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Sham Glycerin Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Total Sham-Corrected Glycerin Summary Statistics by Test Product Group

  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 the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Menthol Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Sham Menthol Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Total Sham-Corrected Menthol Summary Statistics by Test Product Group

  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 the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Propylene Glycol Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Sham Propylene Glycol Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Total Sham-Corrected Propylene Glycol Summary Statistics by Test Product Group

  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 the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Formaldehyde Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Sham Formaldehyde Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Total Sham-Corrected Formaldehyde Summary Statistics by Test Product Group

  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 the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Acetaldehyde Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Sham Acetaldehyde Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Total Sham-Corrected Acetaldehyde Summary Statistics by Test Product Group

  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 the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Acrolein Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Sham Acrolein Residue Summary Statistics by Test-Product Group

  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 container (capturing the specific analyte). Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 sec) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

• Total Sham-Corrected Acrolein Summary Statistics by Test Product Group

  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 the same type of trapping container. Each sample consisted of all the exhaled breath occurring during 10 puffs, each with 5 second puff duration (+/- 1 sec), over \~5 min (one puff approximately every 30 secs) collected in the respective sample collection containers. Sham-corrected analyte amounts were computed by subtracting corresponding sham response values from test product response values.

  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)

Secondary Outcomes (17)

• Cartridge Weight (g) Change Summary Statistics for Sample 1 (Propylene Glycol, Glycerin, Nicotine, Menthol) by Test Product in the Exhaled-Breath Sessions

  Samples collected during the approximately 1 hour controlled exhaled breath product use session 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)

• Cartridge Weight (g) Change Summary Statistics for Sample 2 (Formaldehyde, Acetaldehyde, Acrolein) by Test Product in the Exhaled-Breath Sessions

  Samples collected during the approximately 1 hour controlled exhaled breath product use session 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)

• Summary Statistics of Total Cartridge Weight Change by Test Product, Per Subject, During the Ad Libitum-Use Sessions

  Samples were collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)

• Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions

  Samples were collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)

• Summary Statistics of Puff Count by Test Product During the Ad Libitum-Use Sessions

  Data was collected over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)

Study Arms (4)

ABDC

EXPERIMENTAL

Subjects administered 2 menthol and and 2 non-menthol test e-vapor products: Product A (XL25F) on Day 1, Product B (XL40CB) on Day 2, Product D (XL40MB) on Day 3 and Product C (XL35WM) on Day 4

Other: e-Vapor Product A; Other: e-Vapor Product B; Other: e-Vapor Product C; Other: e-Vapor Product D

BCAD

EXPERIMENTAL

Subjects administered 2 menthol and and 2 non-menthol test e-vapor products: Product B (XL40CB) on Day 1, Product C (XL35WM) on Day 2, Product A (XL25F) on Day 3 and Product D (XL40MB) on Day 4

Other: e-Vapor Product A; Other: e-Vapor Product B; Other: e-Vapor Product C; Other: e-Vapor Product D

CDBA

EXPERIMENTAL

Subjects administered 2 menthol and and 2 non-menthol test e-vapor products: Product C (XL35WM) on Day 1 Product D (XL40MB) on Day 2, Product B (XL40CB) on Day 3 and Product A (XL25F) on Day 4

Other: e-Vapor Product A; Other: e-Vapor Product B; Other: e-Vapor Product C; Other: e-Vapor Product D

DACB

EXPERIMENTAL

Subjects administered 2 menthol and and 2 non-menthol test e-vapor products: Product D (XL40MB) on Day 1, Product A (XL25F) on Day 2, Product C (XL35WM) on Day 3 and Product B (XL40CB) on Day 4

Other: e-Vapor Product A; Other: e-Vapor Product B; Other: e-Vapor Product C; Other: e-Vapor Product D

Interventions

e-Vapor Product A OTHER

e-Vapor product XL25F

Also known as: MarkTen® XL Fusion [2.5% nicotine by weight {NBW}] formerly marketed by NuMark LLC

ABDC; BCAD; CDBA; DACB

e-Vapor Product B OTHER

e-Vapor product XL40CB

Also known as: MarkTen® XL Bold Classic [4.0% NBW] formerly marketed by NuMark LLC

ABDC; BCAD; CDBA; DACB

e-Vapor Product C OTHER

e-Vapor product XL35WM

Also known as: MarkTen® XL Winter Mint [3.5% NBW] formerly marketed by NuMark LLC

ABDC; BCAD; CDBA; DACB

e-Vapor Product D OTHER

e-Vapor product XL40MB

Also known as: MarkTen® XL Bold Menthol [4.0% NBW] formerly marketed by NuMark LLC

ABDC; BCAD; CDBA; DACB

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject candidates must satisfy the following criteria before being enrolled in the study:
• provide voluntary consent to participate, as documented by the signed institutional review board (IRB)-approved informed consent form (ICF) for the study;
• be between the ages of 21 and 65 years, inclusive, at the time of screening (Visit 1);
• be positive for tobacco use by urine cotinine measurement (≥ 500 ng/mL) at Visit 1 (screening);
• have used nicotine-containing EVPs for the 3 months before Visit 1 (screening) and use of nicotine-containing EVPs ("some days" or "every day") for the past 30 days and at least 4 out of the past 7 days before Visit 1 (screening) and at check-in for Visit 2;
• have negative alcohol, amphetamines, opiates, cannabinoids, phencyclidine, and cocaine urine drug screening results (exhaled breath test for alcohol is also acceptable) at Visit 1 (screening) and at check-in for Visit 2;
• if female (all females), have a negative serum pregnancy test at Visit 1 (screening) and have a negative urine pregnancy test at check-in for Visit 2;
• if female and heterosexually active and of childbearing potential (e.g., not surgically sterile \[i.e., bilateral tubal ligation, hysterectomy, or bilateral oophorectomy\] at least 6 months before Visit 1 \[screening\] or at least 2 years naturally postmenopausal \[follicle-stimulating hormone ≥40 IU/L at Visit 1 (screening)\]), must be using one of the following forms of contraception and agree to continue using it through at least 30 days after the last study product use (if early terminated) or completion of the study:
• hormonal (e.g., oral, transdermal patch, implant, or injection) consistently for at least 3 months before Visit 1 (screening);
• double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 30 days before Visit 1 (screening);
• intrauterine device for at least 3 months before Visit 1 (screening);
• Essure® or similar nonsurgical sterilization procedure at least 3 months before Visit 1 (screening); or
• partner who has been vasectomized for at least 6 months (inclusive) before Visit 1 (screening);
• if male and heterosexually active and capable of fathering a child (e.g., not vasectomized at least 6 months before Visit 1 \[screening\]), must be using a double barrier (i.e., condom with spermicide or diaphragm with spermicide) method of contraception from check-in at Visit 2 until at least 90 days after the last study product use (if early terminated) or completion of the study;
• not plan to quit e-vapor use in the next 30 days;

You may not qualify if:

• Subjects may be excluded from the study if the subject meets any of the criteria listed below at Visit 1 (screening) and Visit 2 or at any time during the study as appropriate. Exceptions may be permitted at the discretion of the investigator in consultation with the Sponsor, providing there would be no additional risk involved for the subject. Any exceptions will be documented.
• have current evidence or any history of congestive heart failure;
• have clinically significant abnormal findings on physical examination, vital signs, ECG, clinical laboratory results, or medical history, in the opinion of the investigator;
• have systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg at Visit 1 (screening) or at check-in for Visit 2;
• have estimated creatinine clearance (by Cockcroft-Gault equation) \<80 mL/minute;
• have liver enzymes (aspartate aminotransferase and alanine aminotransferase) ≥1.5 times the upper limit of normal at Visit 1 (screening);
• have an acute illness (e.g., upper respiratory infection or viral infection) requiring treatment within 2 weeks before check-in at Visit 2;
• have fever (\>100.5°F) at Visit 1 (screening) or at check-in for Visit 2;
• have body mass index (BMI) greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Visit 1 (screening);
• have positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Visit 1 (screening);
• have used prescription or over-the-counter bronchodilator medication (e.g., inhaled or oral β-agonists) within 12 months of Visit 1 (screening) and Visit 2;
• have diabetes mellitus that is not controlled by diet/exercise alone, in the opinion of the investigator;
• have used prescription antidiabetic medication or insulin therapy within 12 months of Visit 1 (screening) and Visit 2;
• have used medication for depression or asthma within 12 months of Visit 1 (screening) and Visit 2;
• have a history of drug or alcohol abuse within 12 months of Visit 1 (screening) and Visit 2;

Sponsors & Collaborators

• Altria Client Services LLC: lead
• Cato Research: collaborator

Study Sites (1)

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

Related Links

• Poster presentation at 2018 Society for Research in Nicotine and Tobacco annual meeting entitled: Exhaled Breath Levels of Selected Constituents From Controlled Use of MarkTen® e-Vapor Products in Adult e-Vapor Users

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

In this study, a cut off of greater than 50% of the samples too low to be detected was used to determine which analytes would be analyzed with a mixed model. Exhaled acetaldehyde and acrolein amounts were not detectable in 100% of subjects; therefore the differences in concentrations between sham and product trials for these analytes were not analyzed as intended in the statistical analysis plan.

Results Point of Contact

• Title: Jeffery Edmiston, Functional Director Clinical Research
• Organization: Altria

Jeffery.S.Edmiston@altria.com

8043352366

Study Officials

• Jeffery S Edmiston, PhD

  Altria Client Services

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 11, 2021
• Study Start: March 27, 2017
• Primary Completion: April 21, 2017
• Study Completion: January 26, 2018
• Last Updated: July 30, 2024
• Results First Posted: July 30, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)