This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study in adult smokers. Subjects are invited to participate to a second part of the study, for 5 additional days, to compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
Use of Myblu e-cigarette with flavor A 2.4% nicotine
Use of Myblu e-cigarette with flavor B 3.6% nicotine
Use of Myblu e-cigarette with flavor C 2.5% nicotine
Celerion
Lincoln, Nebraska, United States
Maximum Nicotine Concentration in Blood
Maximum nicotine concentration in blood (Cmax)
Time frame: 180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)
Concentration of Carboxyhemoglobin in Blood
Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.
Time frame: Baseline and 8 days
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), excreted in urine during 24 hours (creatinine adjusted).
Time frame: Baseline and 8 days
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA), a biomarker of exposure to acrolein, excreted in urine during 24 hours (creatinine adjusted).
Time frame: Baseline and 8 days
Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
Change from baseline in the amount of S-phenyl mercapturic acid (S-PMA), a biomarker of exposure to benzene, excreted in urine during 24 hours (creatinine adjusted).
Time frame: Baseline and 8 days
Level of White Blood Cells
The change from baseline in the level of white blood cells, a biomarker of potential harm.
Time frame: Baseline and 8 days
Spirometry: Forced Expiratory Volume in 1 Second
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Use of Myblu e-cigarette with flavor D 4.0% nicotine
Use of Myblu e-cigarette with flavor E 3.6% nicotine
Use of Myblu e-cigarette with flavor F 2.4% nicotine
Use of Myblu e-cigarette with flavor G 4.0% nicotine
Use of Myblu e-cigarette with flavor H 3.6% nicotine
Forced expiratory volume in 1 second (FEV1) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.
Time frame: Baseline and 8 days
Spirometry: Forced Vital Capacity
Forced vital capacity (FVC) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.
Time frame: Baseline and 8 days
Subjective Measure: Urge to Smoke
Urge to smoke score: Subjects answer the following question "How strong is your urge to smoke right now?" using a visual analogue scale (VAS). The scale ranges from "Not at all", given a score of 0, to "Extremely", given a score of 100, after ad libitum use of the product.
Time frame: 8 days