Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes



Status:Completed
Conditions:Smoking Cessation, Hospital
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:21 - 99
Updated:6/3/2018
Start Date:May 2014
End Date:February 2015

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A Single-Center Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes

This study will assess environmental emissions of selected compounds in a test chamber after
cigarette smoking or e-cigarette vaping.

Secondhand smoke is the aged and diluted combination of smoke exhaled by a smoker and
sidestream smoke (smoke from the lit end of a cigarette). Electronic cigarettes are different
from tobacco-burning cigarettes in that they produce vapor, not smoke. For consistency with
common usage, secondhand smoke (SHS) refers to true secondhand smoke from cigarettes and
secondhand vapor from e-cigarettes.

The goals of this study are to 1) increase understanding of the composition of SHS from
e-cigarettes, 2) quantitatively compare the amount of SHS generated by e-cigarettes and a
market sample of commercial e-cigarettes to leading brand styles of commercial
tobacco-burning cigarettes, and 3) quantitate the emission factors of e-cigarettes including
the market-sample e-cigarettes.

Inclusion Criteria:

1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) and
complete questionnaires written in English.

2. Generally healthy males or females, 21 years of age or older at Screening.

3. Able to meet cohort-specific requirements as follows:

Cohort 1 - Leading U.S. tobacco-burning non-menthol cigarette, and

Cohort 2 - Leading U.S. tobacco-burning menthol cigarette:

- self-reports at the Screening Visit smoking at least 5 cigarettes per day and
inhaling the smoke, for at least 3 months prior to Screening

- self-reports smoking Leading U.S. tobacco-burning non-menthol cigarette or
Leading U.S. tobacco-burning menthol cigarette as usual brand (UB) cigarettes [UB
cigarette is defined as the cigarette brand style currently smoked most
frequently by the participant];

Cohort 3 - Electronic cigarette #1 smokers, and

Cohort 4 - Electronic cigarette #2 smokers:

- self-reports at the Screening Visit smoking a non-menthol e-cigarette at least
once per day, for at least 3 months prior to Screening;

- willing to switch from using their current e-cigarette brand style to using a
different e-cigarette brand style during the study;

Cohort 5 - Electronic cigarette #3 smokers:

- self-reports at the Screening Visit smoking a menthol e-cigarette at least once
per day, for at least 3 months prior to Screening;

- willing to switch from using their current e-cigarette brand style to using a
different e-cigarette brand style during the study;

Cohort 6 - U.S Market-sample electronic cigarette smokers:

- self-reports at the Screening Visit smoking the selected U.S. market-sample
e-cigarettes (menthol or non-menthol) at least once per day, for at least three
months prior to Screening;

- willing to continue exclusive use of their preferred style (flavor) of
e-cigarette during the study.

4. Females of childbearing potential must be willing to use a form of contraception
acceptable to the Investigator from the time of signing informed consent until study
discharge or be surgically sterile for at least 90 days prior to enrollment;

5. Able to safely perform the required study procedures, as determined by the
Investigator.

Exclusion Criteria:

1. Clinically significant or unstable/uncontrolled acute or chronic medical conditions at
Screening, as determined by the Investigator, that would preclude a participant from
participating safely in the study (e.g., hypertension, asthma, or other lung disease;
cardiac disease; neurological disease; or psychiatric disorders) based on screening
assessments such as safety labs and medical history or physical examination at
Enrollment;

2. Self-reports or safety labs indicate diabetes;

3. At risk for heart disease, as determined by the Investigator;

4. Use of medicine for treatment of depression or asthma;

5. Systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥95 mmHg,
measured after being seated for 5 minutes;

6. Postponing a decision to quit smoking (defined as planning a quit attempt within 30
days of the Screening Visit) to participate in this study;

7. Employed by a tobacco company, the study site, or environmental test chamber vendor;

8. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to
become pregnant during the course of the study;

9. History of claustrophobia;

10. Regularly exposed to solvent fumes or gasoline (e.g., painter, gas-station mini mart
employee);

11. Determined by the Investigator to be inappropriate for this study, including a
participant who is unable to communicate or unwilling to cooperate with the clinical
staff.
We found this trial at
1
site
Stockbridge, Georgia 30281
?
mi
from
Stockbridge, GA
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