Clinical trial NCT04881942: Characterization of Selected Aerosol Constituents Levels in the Exhaled Breath of Adult e-Vapor Users
Official title: Characterization of Selected Aerosol Constituents Levels in the Exhaled Breath of Adult e-Vapor Users During Use of Four e-Vapor Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Lead sponsor: Altria Client Services LLC
Sponsor class: INDUSTRY
Collaborators: name: Cato Research
First posted: 2021-05-11
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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

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.

Eligibility criteria: Inclusion Criteria:

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

  1. provide voluntary consent to participate, as documented by the signed institutional review board (IRB)-approved informed consent form (ICF) for the study;
  2. be between the ages of 21 and 65 years, inclusive, at the time of screening (Visit 1);
  3. be positive for tobacco use by urine cotinine measurement (≥ 500 ng/mL) at Visit 1 (screening);
  4. 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;
  5. 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;
  6. 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;
  7. 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);
  8. 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;
  9. not plan to quit e-vapor use in the next 30 days;
  10. be willing to use all assigned EVPs during the study; and
  11. be willing and able to comply with the requirements of the study.

Exclusion Criteria:

* 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.

  1. 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);
  2. have current evidence or any history of congestive heart failure;
  3. have clinically significant abnormal findings on physical examination, vital signs, ECG, clinical laboratory results, or medical history, in the opinion of the investigator;
  4. 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;
  5. have estimated creatinine clearance (by Cockcroft-Gault equation) \<80 mL/minute;
  6. have liver enzymes (aspartate aminotransferase and alanine aminotransferase) ≥1.5 times the upper limit of normal at Visit 1 (screening);
  7. have an acute illness (e.g., upper respiratory infection or viral infection) requiring treatment within 2 weeks before check-in at Visit 2;
  8. have fever (\>100.5°F) at Visit 1 (screening) or at check-in for Visit 2;
  9. have body mass index (BMI) greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Visit 1 (screening);
  10. have positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Visit 1 (screening);
  11. 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;
  12. have diabetes mellitus that is not controlled by diet/exercise alone, in the opinion of the investigator;
  13. have used prescription antidiabetic medication or insulin therapy within 12 months of Visit 1 (screening) and Visit 2;
  14. have used medication for depression or asthma within 12 months of Visit 1 (screening) and Visit 2;
  15. have a history of drug or alcohol abuse within 12 months of Visit 1 (screening) and Visit 2;
  16. have had allergic or other known adverse reactions to menthol, propylene glycol, or glycerol;
  17. if female, be pregnant, nursing, or planning to become pregnant during the study;
  18. 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;
  19. 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;
  20. 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;
  21. be a current employee or personnel involved with the study at the site; or
  22. have participated in two or more ALCS studies within the past 12-month period before Visit 1 (screening) and check in at Visit 2.

Primary outcomes:
measure: Nicotine Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Sham Nicotine Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Total Sham-Corrected Nicotine Summary Statistics by Test Product Group
timeFrame: 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)
measure: Glycerin Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Sham Glycerin Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Total Sham-Corrected Glycerin Summary Statistics by Test Product Group
timeFrame: 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)
measure: Menthol Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Sham Menthol Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Total Sham-Corrected Menthol Summary Statistics by Test Product Group
timeFrame: 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)
measure: Propylene Glycol Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Sham Propylene Glycol Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Total Sham-Corrected Propylene Glycol Summary Statistics by Test Product Group
timeFrame: 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)
measure: Formaldehyde Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Sham Formaldehyde Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Total Sham-Corrected Formaldehyde Summary Statistics by Test Product Group
timeFrame: 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)
measure: Acetaldehyde Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Sham Acetaldehyde Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Total Sham-Corrected Acetaldehyde Summary Statistics by Test Product Group
timeFrame: 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)
measure: Acrolein Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Sham Acrolein Residue Summary Statistics by Test-Product Group
timeFrame: 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)
measure: Total Sham-Corrected Acrolein Summary Statistics by Test Product Group
timeFrame: 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:
measure: Cartridge Weight (g) Change Summary Statistics for Sample 1 (Propylene Glycol, Glycerin, Nicotine, Menthol) by Test Product in the Exhaled-Breath Sessions
timeFrame: 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)
measure: Cartridge Weight (g) Change Summary Statistics for Sample 2 (Formaldehyde, Acetaldehyde, Acrolein) by Test Product in the Exhaled-Breath Sessions
timeFrame: 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)
measure: Summary Statistics of Total Cartridge Weight Change by Test Product, Per Subject, During the Ad Libitum-Use Sessions
timeFrame: 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)
measure: Total Weight Change by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions
timeFrame: 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)
measure: Summary Statistics of Puff Count by Test Product During the Ad Libitum-Use Sessions
timeFrame: 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)
measure: Average Puff Duration by Test Product During the Ad Libitum-Use Sessions
timeFrame: 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)
measure: Total Puff Duration by Test Product During the Ad Libitum-Use Sessions
timeFrame: 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)
measure: Total Cartridges Used by Test Product During the Ad Libitum-Use Sessions
timeFrame: 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)
measure: Summary of Binary VAS-Derived Categorical "Use Product Again Questionnaire" Scores by Test Product
timeFrame: 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)
measure: Summary of Ordinal VAS-Derived Categorical "Use Product Again Questionnaire" Scores by Test Product
timeFrame: 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)
measure: Puff Count by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions
timeFrame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
measure: Average Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions
timeFrame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
measure: Total Puff Duration by Test Product and Individual Cartridge During the Ad-Libitum-Use Sessions
timeFrame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
measure: Total Weight Change by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
timeFrame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
measure: Average Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
timeFrame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
measure: Puff Count by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
timeFrame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
measure: Total Puff Duration by Test Product, Per Completed Cartridge, During the Ad-Libitum-Use Sessions
timeFrame: Over the 12-hour ad libitum product use session on the day the subject was assigned the test product (according to the randomization scheme)
Other outcomes:
Locations:
city: High Point
country: United States
facility: High Point Clinical Trials Center
state: North Carolina
Study officials:
affiliation: Altria Client Services
name: Jeffery S Edmiston, PhD
role: STUDY_DIRECTOR
References: