Tobacco UseNCT04881942

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

A study testing e-Vapor Product A, e-Vapor Product B and e-Vapor Product C in people with Tobacco Use, run by Altria Client Services LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Tobacco Use
What is being tested?: e-Vapor Product A, e-Vapor Product B and e-Vapor Product C
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 27 Mar 2017to 26 Jan 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

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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;
be willing to use all assigned EVPs during the study; and
be willing and able to comply with the requirements of the study.

Who cannot join

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 a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, diabetes, existing respiratory diseases (especially bronchospastic diseases and asthma), immunologic, psychiatric, cardiovascular disease, or any other condition(s) that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results (Note: Chronic medical conditions controlled and on stable medications [over the past 3 months] may not be exclusionary per investigator discretion);
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;

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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;
have had allergic or other known adverse reactions to menthol, propylene glycol, or glycerol;
if female, be pregnant, nursing, or planning to become pregnant during the study;
have participated in a clinical study for an investigational drug, medical device, biologic, or for a tobacco product within 30 days before Visit 1 (screening) and Visit 2;
be a current or former employee of the tobacco industry or a first-degree relative (e.g., parent, spouse, sibling, child) of a current or former employee of the tobacco industry or a named party or class representative in litigation with any tobacco company;
have been involved in the development of the study design/conduct or be a first-degree relative (e.g., parent, spouse, sibling, child) of someone involved in the development of the study design/conduct;
be a current employee or personnel involved with the study at the site; or
have participated in two or more ALCS studies within the past 12-month period before Visit 1 (screening) and check in at Visit 2.

Trial locations and contacts

1 site in 1 country.

United States1 site

High Point Clinical Trials Center
High Point, North Carolina, 27265

Other trials in United States

About this study

Official title: Characterization of Selected Aerosol Constituents Levels in the Exhaled Breath of Adult e-Vapor Users During Use of Four e-Vapor Products

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.

Read the detailed 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 (which are no longer manufactured or sold commercially). The study will enroll approximately 32 adult e-vapor-using (with no more that 60% of either sex). Each of the 32 subjects will provide two exhaled breath samples (10 puffs for each sample) for all four test products. Subjects will make two visits to the site, one screening visit and one 4 day in-clinic visit to provide exhalation samples for four test products (one each day for 4 days). Subjects will also use their assigned test product ad libitum for 12 hours each day after the collection of exhaled breath samples. Subjects will be randomly assigned to a test product-use schedule at Visit 2, with one test product used per day. The anticipated study duration for each subject from screening through completion of all study participation will be approximately 34 days.

Conditions: Tobacco Use
Being tested: e-Vapor Product A, e-Vapor Product B, e-Vapor Product C, e-Vapor Product D
Medical subject headings: Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

e-Vapor Product AOther
Also called MarkTen® XL Fusion [2.5% nicotine by weight {NBW}] formerly marketed by NuMark LLC
e-Vapor product XL25F
e-Vapor Product BOther
Also called MarkTen® XL Bold Classic [4.0% NBW] formerly marketed by NuMark LLC
e-Vapor product XL40CB
e-Vapor Product COther
Also called MarkTen® XL Winter Mint [3.5% NBW] formerly marketed by NuMark LLC
e-Vapor product XL35WM
e-Vapor Product DOther
Also called MarkTen® XL Bold Menthol [4.0% NBW] formerly marketed by NuMark LLC
e-Vapor product XL40MB

Study groups in NCT04881942
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: e-Vapor Product A; Other: e-Vapor Product B; Other: e-Vapor Product C; Other: e-Vapor Product D

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Difference in recorded weight of Sample 1, measured in grams, collected before and after product use in Exhaled Breath Sessions. Sample 1 was used to collect propylene glycol, glycerin, nicotine and menthol, and was collected approximately 1 hour before Sample 2.
Measured: 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
Difference in recorded weight of Sample 2, measured in grams, collected before and after product use in Exhaled Breath Sessions, Sample 2 was used to collect formaldehyde, acetaldehyde and acrolein, and was collected approximately 1 hour after Sample 1.
Measured: 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
Difference in recorded weight (measured in grams) by test product, per subject, collected before and after product use in ad libitum sessions
Measured: 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
Change in cartridge weight (measured in grams) as measured before and after a 12-hour ad-libitum use session of the product.
Measured: 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
Number of puffs, by test product, per subject, taken during 12-hour ad libitum product use session
Measured: 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)
Average Puff Duration by Test Product During the Ad Libitum-Use Sessions
Seconds per puff taken, by test product, per subject, during 12-hour ad libitum product use session
Measured: 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)
Total Puff Duration by Test Product During the Ad Libitum-Use Sessions
Total seconds puffing by test product, per subject, taken during 12-hour ad libitum product use session
Measured: 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)
Total Cartridges Used by Test Product During the Ad Libitum-Use Sessions
Total cartridges used by test product, per subject, taken during 12-hour ad libitum product use session
Measured: 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)
Summary of Binary VAS-Derived Categorical "Use Product Again Questionnaire" Scores by Test Product
Visual Analog Scale (VAS) measuring self-reported response to "Use the product again" questionnaire was collected after each product use session. The questionnaire consists of a single question ("If given the opportunity, I would want to use this product again"). Participants indicated their willingness to use the product again by pointing to a line measuring 100mm, with scores measured from left to right and ranging between 0 to 100 mm. Scores closer to the right, and thus higher on the scale, indicated a greater willingness to utilize the product again. Raw scores were converted to a binary score as follows: VAS scores < 50 mm ≈ unwillingness to use the product again, and VAS scores ≥ 50 mm ≈ willingness to use product again.
Measured: Data was collected at the end of the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Summary of Ordinal VAS-Derived Categorical "Use Product Again Questionnaire" Scores by Test Product
Visual Analog Scale (VAS) measuring self-reported response to willingness to use study product again. Questionnaire was collected after each product use session. Questionnaire consists of a single question ("If given the opportunity, I would want to use this product again") with VAS response range from "Definitely Would Not" to "Don't Care" to "Definitely Would". Participants indicated their willingness to use the product again by pointing to a line measuring 100mm, with scores measured from left to right and ranging between 0 to 100 mm. Scores closer to the right, and thus higher on the scale, indicated a greater willingness to utilize the product again. The raw scores were then converted to a binary, "unwilling" vs. "willing" to use response. Additionally, a 3-level ordinal response was computed using "unwilling" (VAS < 50 mm), "don't care" (VAS = 50 mm), and "willing" (VAS > 50 mm).
Measured: Data was collected at the end of the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions
Puff Count by Test Product (Pooled Over Cartridges) during 12-hour ad-libitum-use session of the product.
Measured: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions
Average puff duration (measured in seconds) by Test Product (Pooled Over Cartridges) during 12-hour ad-libitum-use session of the product.
Measured: 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 Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions
Total Puff Duration (measured in seconds) by Test Product (pooled over cartridges) during 12-hour ad-libitum-use session of the product.
Measured: 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, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
Change in cartridge weight (measured in grams) as measured before and after a 12-hour ad-libitum use session of the product.
Measured: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Average Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
Average puff duration (measured in seconds) by Test Product, per completed cartridge, during a 12-hour ad-libitum use session of the product.
Measured: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Puff Count by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
Puff count by Test Product, per completed cartridge, during a 12-hour ad-libitum use session of the product.
Measured: 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 Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
Total Puff Duration (measured in seconds) by Test Product, per completed cartridge, during a 12-hour ad-libitum use session of the product.
Measured: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 201726 Jan 2018

First posted11 May 2021
Study start27 Mar 2017
Primary completion21 Apr 2017
Study completion26 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tobacco UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model 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.
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04881942
Sponsor's protocol ID: ALCS-RA-17-06-EV
Status last verified: Feb 2024
First submitted: 26 Apr 2021
Last updated: 30 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Tobacco Use trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterization of Selected Aerosol Constituents Levels in the Exhaled Breath of Adult e-Vapor Users During Use of Four e-Vapor Products
ClinicalTrials.gov ID: NCT04881942
Acronym / sponsor ID: ALCS-RA-17-06-EV
Conditions: Tobacco Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Altria Client Services LLCIndustry (pharma, biotech, devices)
Collaborators: Cato Research
Study start: 27 Mar 2017 (actual)
Primary completion: 21 Apr 2017 (actual)
Study completion: 26 Jan 2018 (actual)
First posted: 11 May 2021 (actual)
Results: Posted 30 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed 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 (which are no longer manufactured or sold commercially). The study will enroll approximately 32 adult e-vapor-using (with no more that 60% of either sex). Each of the 32 subjects will provide two exhaled breath samples (10 puffs for each sample) for all four test products. Subjects will make two visits to the site, one screening visit and one 4 day in-clinic visit to provide exhalation samples for four test products (one each day for 4 days). Subjects will also use their assigned test product ad libitum for 12 hours each day after the collection of exhaled breath samples. Subjects will be randomly assigned to a test product-use schedule at Visit 2, with one test product used per day. The anticipated study duration for each subject from screening through completion of all study participation will be approximately 34 days.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model 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.

Arm	Type	Receives
ABDC	Experimental	Other: e-Vapor Product A, Other: e-Vapor Product B, Other: e-Vapor Product C, Other: e-Vapor Product DSubjects 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
BCAD	Experimental	Other: e-Vapor Product A, Other: e-Vapor Product B, Other: e-Vapor Product C, Other: e-Vapor Product DSubjects 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
CDBA	Experimental	Other: e-Vapor Product A, Other: e-Vapor Product B, Other: e-Vapor Product C, Other: e-Vapor Product DSubjects 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
DACB	Experimental	Other: e-Vapor Product A, Other: e-Vapor Product B, Other: e-Vapor Product C, Other: e-Vapor Product DSubjects 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

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Subject candidates must satisfy the following criteria before being enrolled in the study:

Key exclusion criteria (23 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
e-Vapor Product AAlso: MarkTen® XL Fusion [2.5% nicotine by weight {NBW}] formerly marketed by NuMark LLCe-Vapor product XL25F	Other	ABDC, BCAD, CDBA, DACB
e-Vapor Product BAlso: MarkTen® XL Bold Classic [4.0% NBW] formerly marketed by NuMark LLCe-Vapor product XL40CB	Other	ABDC, BCAD, CDBA, DACB
e-Vapor Product CAlso: MarkTen® XL Winter Mint [3.5% NBW] formerly marketed by NuMark LLCe-Vapor product XL35WM	Other	ABDC, BCAD, CDBA, DACB
e-Vapor Product DAlso: MarkTen® XL Bold Menthol [4.0% NBW] formerly marketed by NuMark LLCe-Vapor product XL40MB	Other	ABDC, BCAD, CDBA, DACB

Primary outcome

Nicotine Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Sham Nicotine Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Total Sham-Corrected Nicotine Summary Statistics by Test Product Group
Time frame: 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 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.
Glycerin Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Sham Glycerin Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Total Sham-Corrected Glycerin Summary Statistics by Test Product Group
Time frame: 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 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.
Menthol Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Sham Menthol Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Total Sham-Corrected Menthol Summary Statistics by Test Product Group
Time frame: 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 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.
Propylene Glycol Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Sham Propylene Glycol Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Total Sham-Corrected Propylene Glycol Summary Statistics by Test Product Group
Time frame: 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 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.
Formaldehyde Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Sham Formaldehyde Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Total Sham-Corrected Formaldehyde Summary Statistics by Test Product Group
Time frame: 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 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.
Acetaldehyde Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Sham Acetaldehyde Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Total Sham-Corrected Acetaldehyde Summary Statistics by Test Product Group
Time frame: 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 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.
Acrolein Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Sham Acrolein Residue Summary Statistics by Test-Product Group
Time frame: 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 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.
Total Sham-Corrected Acrolein Summary Statistics by Test Product Group
Time frame: 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 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.

17 secondary outcomes

Cartridge Weight (g) Change Summary Statistics for Sample 1 (Propylene Glycol, Glycerin, Nicotine, Menthol) by Test Product in the Exhaled-Breath Sessions
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Average Puff Duration by Test Product During the Ad Libitum-Use Sessions
Time frame: 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)
Total Puff Duration by Test Product During the Ad Libitum-Use Sessions
Time frame: 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)
Total Cartridges Used by Test Product During the Ad Libitum-Use Sessions
Time frame: 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)
Summary of Binary VAS-Derived Categorical "Use Product Again Questionnaire" Scores by Test Product
Time frame: Data was collected at the end of the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Summary of Ordinal VAS-Derived Categorical "Use Product Again Questionnaire" Scores by Test Product
Time frame: Data was collected at the end of the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions
Time frame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions
Time frame: 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 Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions
Time frame: 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, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
Time frame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Average Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
Time frame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Puff Count by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
Time frame: 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 Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
Time frame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)

Results and safety

Results posted to the registry on 30 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABDC	8	8
BCAD	8	8
CDBA	8	8
DACB	8	8
Day -1 Trial	3	0

Primary outcome: Nicotine Residue Summary Statistics by Test-Product Group

Time frame: 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). Mean (Standard Deviation). Unit: Micrograms

Measure	e-Vapor Product A n = 32	e-Vapor Product B n = 32	e-Vapor Product C n = 32	e-Vapor Product D n = 31
Value	87.1 (120.11)	192.3 (268.53)	174.1 (208.64)	182.8 (253.88)

Primary outcome: Sham Nicotine Residue Summary Statistics by Test-Product Group

Measure	e-Vapor Product A n = 32	e-Vapor Product B n = 32	e-Vapor Product C n = 32	e-Vapor Product D n = 32
Value	0.9 (0.66)	0.9 (0.66)	0.9 (0.70)	0.9 (0.69)

Primary outcome: Total Sham-Corrected Nicotine Summary Statistics by Test Product Group

Measure	e-Vapor Product A n = 32	e-Vapor Product B n = 32	e-Vapor Product C n = 32	e-Vapor Product D n = 31
Value	86.1 (120.40)	191.4 (268.78)	173.1 (208.93)	181.8 (254.23)

e-Vapor Product A: Mean Difference (Net): 89.44 (95% CI 15.77 to 163.11), p = 0.0184, ANCOVA
e-Vapor Product B: Mean Difference (Net): 195.70 (95% CI 122.01 to 269.38), p <.0001, ANCOVA
e-Vapor Product C: Mean Difference (Net): 168.83 (95% CI 95.17 to 242.50), p <.0001, ANCOVA

Primary outcome: Glycerin Residue Summary Statistics by Test-Product Group

Measure	e-Vapor Product A n = 32	e-Vapor Product B n = 32	e-Vapor Product C n = 32	e-Vapor Product D n = 31
Value	5964.4 (5029.33)	5707.3 (5015.41)	6516.6 (5387.80)	5682.4 (5156.04)

17 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
e-Vapor Product A	0 of 32 (0%)	3 of 32 (9.4%)	0 of 32
e-Vapor Product B	0 of 32 (0%)	1 of 32 (3.1%)	0 of 32
e-Vapor Product C	0 of 32 (0%)	3 of 32 (9.4%)	0 of 32
e-Vapor Product D	0 of 32 (0%)	4 of 32 (12.5%)	0 of 32
Day -1 Product Trial Non-randomized Subjects	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 UsersLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffery S Edmiston, PhD study director

Altria Client Services

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing e-Vapor Product A, e-Vapor Product B and e-Vapor Product C in people with Tobacco Use, run by Altria Client Services LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nicotine Residue Summary Statistics by Test-Product Group (time frame: 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)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04881942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.