Study to Evaluate Constituents in Exhaled Breath and Room Air From Use of E-vapor Products and Co… (NCT03605641) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate Constituents in Exhaled Breath and Room Air From Use of E-vapor Products and Conventional Cigarettes
Canada43 participantsStarted 2018-09-17
Plain-language summary
An open-label, single center, three-arm observational study to examine emissions from e-cigarettes versus conventional cigarettes under three environmental settings of typical residential, office and hospitality facilities.
Who can participate
Age range21 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be informed of the nature of the study and agree to and are able to read, review, and sign the informed consent document (in English) prior to the first study procedure. The Investigator must be satisfied that the volunteer has the ability to read and communicate in English in order to participate in the study.
✓. Subjects screened as a part of an IRB-approved General Screening Protocol at the CRO site may be included in this study without additional Screening procedures provided all the required Screening procedures have been performed within 60 days prior to Clinic Visit 1.
✓. Be a healthy male or female volunteer aged 21 - 65 years at the time of Screening Visit.
✓. Have a positive urine cotinine result at Screening (Screening Visit) of \>200 ng/ml.
✓. Be judged by the Investigator to be in good general health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any clinical testing (laboratory tests, ECG, vital signs) can be repeated at the discretion of the Investigator and judged to be not clinically significant for study participation.
✓. Agree to abide by the study restrictions and return for the required assessments.
✓. Have a self-reported daily conventional cigarette consumption rate of a minimum of 10 cigarettes per day for a minimum of 3 months prior to Screening Visit.
Exclusion criteria
✕
What they're measuring
1
Exhaled Breath Sample (EBS) - Nicotine
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
2
Exhaled Breath Sample (EBS) - Propylene glycol
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
3
Exhaled Breath Sample (EBS) - Vegetable Glycerin
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
4
Exhaled Breath Sample (EBS) - Carbonyls
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
5
Room Air Sample (RAS) - Nicotine
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
6
Room Air Sample (RAS) - Propylene glycol
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
7
Room Air Sample (RAS) - Vegetable Glycerin
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
. Report receiving any investigational product within 30 days prior to Screening (Screening Visit).
✕. Report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, oncologic or neurologic system(s) or psychiatric disease as determined by the Investigator.
✕. Have any clinically significant results from laboratory tests, physical examinations, vital signs assessments, and electrocardiograms, as judged by the Investigator.
✕. Report a clinically significant illness during the 30 days prior to enrollment, as determined by the Investigator.
✕. Report a history of drug or alcohol addiction or abuse within the past 1 year.
✕. Have positive screen for alcohol or drugs of abuse at Screening (Screening Visit) or check-in at Clinical Visit 1.
✕. Have positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (anti-HCV).
✕. Have body mass index (BMI) greater than 40 kg/m2 or less than 18 kg/m2 at Screening (Screening Visit).
8
Room Air Sample (RAS) - Carbonyls
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
9
Room Air Sample (RAS) - Volatile organic compounds
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
10
Room Air Samples (RAS) - Metals
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
11
Room Air Samples (RAS) - PM2.5 Particles
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
12
Room Air Samples (RAS) - PM10 Particles
Timeframe: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)