An Open-Label, Randomized, Crossover Study to Assess Nicotine Uptake, Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Puff Topography With Use of mybluTM Electronic Cigarettes in Adult Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Concentration of Carboxyhemoglobin in Blood
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •smoking an average of at least 10 manufactured combustible cigarettes per day for at least 12 months prior to Screening
- •tested positive for urine cotinine (≥ 200 ng/mL) at Screening
- •exhaled carbon monoxide > 10 ppm (parts per million) at Screening
排除标准
- •relevant illness history
- •relevant medication use
- •body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screening
- •allergy to propylene glycol or glycerin
- •use of nicotine-containing products other than manufactured combustible cigarettes within 14 days prior to Check-in
- •use of any prescription smoking cessation treatments within 3 months prior to Check-in
- •smokers who draw smoke from the cigarette into the mouth and throat but do not inhale
- •planning to quit smoking during the study
- •female subjects who are pregnant, lactating, or intend to become pregnant
研究组 & 干预措施
Product use sequence ABDC
Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
干预措施: Myblu flavor A_2.4 (Other)
Product use sequence ABDC
Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
干预措施: Myblu flavor B_2.4 (Other)
Product use sequence ABDC
Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
干预措施: Myblu flavor C_2.4 (Other)
Product use sequence ABDC
Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
干预措施: Myblu flavor D_2.4 (Other)
Product use sequence BCAD
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor A_2.4 (Other)
Product use sequence BCAD
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor B_2.4 (Other)
Product use sequence BCAD
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor C_2.4 (Other)
Product use sequence BCAD
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor D_2.4 (Other)
Product use sequence CDBA
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor A_2.4 (Other)
Product use sequence CDBA
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor C_2.4 (Other)
Product use sequence CDBA
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor D_2.4 (Other)
Product use sequence DACB
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor A_2.4 (Other)
Product use sequence DACB
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor B_2.4 (Other)
Product use sequence DACB
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor C_2.4 (Other)
Product use sequence DACB
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor D_2.4 (Other)
Product use sequence EFHG
Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
干预措施: Myblu flavor E_1.2 (Other)
Product use sequence EFHG
Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
干预措施: Myblu flavor F_1.2 (Other)
Product use sequence EFHG
Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
干预措施: Myblu flavor G_2.4 (Other)
Product use sequence EFHG
Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
干预措施: Myblu flavor H_2.4 (Other)
Product use sequence FGEH
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor E_1.2 (Other)
Product use sequence FGEH
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor F_1.2 (Other)
Product use sequence FGEH
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor G_2.4 (Other)
Product use sequence FGEH
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor H_2.4 (Other)
Product use sequence GHFE
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor E_1.2 (Other)
Product use sequence GHFE
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor F_1.2 (Other)
Product use sequence GHFE
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor G_2.4 (Other)
Product use sequence GHFE
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor H_2.4 (Other)
Product use sequence HEGF
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor E_1.2 (Other)
Product use sequence HEGF
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor F_1.2 (Other)
Product use sequence HEGF
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor G_2.4 (Other)
Product use sequence HEGF
Same as previous arm, but in a different randomization order.
干预措施: Myblu flavor H_2.4 (Other)
结局指标
主要结局
Concentration of Carboxyhemoglobin in Blood
时间窗: Baseline and 8 days
Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
时间窗: Baseline and 8 days
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).
Maximum Nicotine Concentration in Blood
时间窗: 180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)
Maximum nicotine concentration in blood (Cmax)
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
时间窗: Baseline and 8 days
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).
Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
时间窗: Baseline and 8 days
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).
次要结局
- Level of White Blood Cells(Baseline and 8 days)
- Subjective Measure: Urge to Smoke(8 days)
- Spirometry: Forced Expiratory Volume in 1 Second(Baseline and 8 days)
- Spirometry: Forced Vital Capacity(Baseline and 8 days)