A Study to Evaluate Nicotine Uptake and Biomarkers in Adult Smokers Using mybluTM Electronic Cigarettes

• Sponsor: Fontem US LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04429932
• Collaborator: Fontem Ventures BV (Industry)
• Enrollment: 39
• Location: 1
• Arms: 8
• Actual Duration (Months): 2
• Patients Per Site Per Month: 19.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Other: Myblu flavor A_2.4; Other: Myblu flavor B_2.4; Other: Myblu flavor C_2.4; Other: Myblu flavor D_2.4; Other: Myblu flavor E_1.2; Other: Myblu flavor F_1.2; Other: Myblu flavor G_2.4; Other: Myblu flavor H_2.4	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: Dec 1, 2019
• Actual Primary Completion Date: Jan 31, 2020
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Other: Myblu flavor A_2.4; Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine; Other: Myblu flavor B_2.4; Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine; Other: Myblu flavor C_2.4; Use of Myblu e-cigarette with flavor C at 2.4% nicotine; Other: Myblu flavor D_2.4; Use of Myblu e-cigarette with flavor D at 2.4% nicotine
Experimental: Product use sequence BCAD Same as previous arm, but in a different randomization order.	Other: Myblu flavor A_2.4; Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine; Other: Myblu flavor B_2.4; Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine; Other: Myblu flavor C_2.4; Use of Myblu e-cigarette with flavor C at 2.4% nicotine; Other: Myblu flavor D_2.4; Use of Myblu e-cigarette with flavor D at 2.4% nicotine
Experimental: Product use sequence CDBA Same as previous arm, but in a different randomization order.	Other: Myblu flavor A_2.4; Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine; Other: Myblu flavor C_2.4; Use of Myblu e-cigarette with flavor C at 2.4% nicotine; Other: Myblu flavor D_2.4; Use of Myblu e-cigarette with flavor D at 2.4% nicotine
Experimental: Product use sequence DACB Same as previous arm, but in a different randomization order.	Other: Myblu flavor A_2.4; Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine; Other: Myblu flavor B_2.4; Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine; Other: Myblu flavor C_2.4; Use of Myblu e-cigarette with flavor C at 2.4% nicotine; Other: Myblu flavor D_2.4; Use of Myblu e-cigarette with flavor D at 2.4% nicotine
Experimental: 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).	Other: Myblu flavor E_1.2; Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine; Other: Myblu flavor F_1.2; Fse of Myblu e-cigarette with flavor F at 1.2% nicotine; Other: Myblu flavor G_2.4; Use of Myblu e-cigarette with flavor G at 2.4% nicotine; Other: Myblu flavor H_2.4; Use of Myblu e-cigarette with flavor H at 2.4% nicotine
Experimental: Product use sequence FGEH Same as previous arm, but in a different randomization order.	Other: Myblu flavor E_1.2; Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine; Other: Myblu flavor F_1.2; Fse of Myblu e-cigarette with flavor F at 1.2% nicotine; Other: Myblu flavor G_2.4; Use of Myblu e-cigarette with flavor G at 2.4% nicotine; Other: Myblu flavor H_2.4; Use of Myblu e-cigarette with flavor H at 2.4% nicotine
Experimental: Product use sequence GHFE Same as previous arm, but in a different randomization order.	Other: Myblu flavor E_1.2; Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine; Other: Myblu flavor F_1.2; Fse of Myblu e-cigarette with flavor F at 1.2% nicotine; Other: Myblu flavor G_2.4; Use of Myblu e-cigarette with flavor G at 2.4% nicotine; Other: Myblu flavor H_2.4; Use of Myblu e-cigarette with flavor H at 2.4% nicotine
Experimental: Product use sequence HEGF Same as previous arm, but in a different randomization order.	Other: Myblu flavor E_1.2; Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine; Other: Myblu flavor F_1.2; Fse of Myblu e-cigarette with flavor F at 1.2% nicotine; Other: Myblu flavor G_2.4; Use of Myblu e-cigarette with flavor G at 2.4% nicotine; Other: Myblu flavor H_2.4; Use of Myblu e-cigarette with flavor H at 2.4% nicotine

Outcome Measures

Primary Outcome Measures

1. Maximum Nicotine Concentration in Blood [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)

2. Concentration of Carboxyhemoglobin in Blood [Baseline and 8 days]

   Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.

3. Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours [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).

4. Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours [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).

5. Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours [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).

Secondary Outcome Measures

1. Level of White Blood Cells [Baseline and 8 days]

   The change from baseline in the level of white blood cells, a biomarker of potential harm.

2. Spirometry: Forced Expiratory Volume in 1 Second [Baseline and 8 days]

   The percent-predicted 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.

3. Spirometry: Forced Vital Capacity [Baseline and 8 days]

   The percent-predicted 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.

4. Subjective Measure: Urge to Smoke [8 days]

   Urge to smoke score: Subjects answer the following question "How strong is your urge to smoke right now?" using a visual analogue scale. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

• Fontem US LLC
• Fontem Ventures BV

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Dec 4, 2019
• Statistical Analysis Plan - Feb 26, 2020

More Information

Publications

None provided.

• Responsible Party: Fontem US LLC
• ClinicalTrials.gov Identifier: NCT04429932
• Other Study ID Numbers: CA22736
• First Posted: Jun 12, 2020
• Last Update Posted: Jun 7, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Product Use Sequence ABDC	Product Use Sequence BCAD	Product Use Sequence CDBA	Product Use Sequence DACB	Product Use Sequence EFHG	Product Use Sequence FGEH	Product Use Sequence GHFE	Product Use Sequence HEGF
Arm/Group Description	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 12-hour washout period 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). Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine	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 12-hour washout period 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). Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine
Period Title: Overall Study
STARTED	4	5	5	5	5	5	5	5
COMPLETED	3	5	5	2	5	5	5	5
NOT COMPLETED	1	0	0	3	0	0	0	0

Baseline Characteristics

Arm/Group Title	Product Use Sequence ABDC	Product Use Sequence BCAD	Product Use Sequence CDBA	Product Use Sequence DACB	Product Use Sequence EFHG	Product Use Sequence FGEH	Product Use Sequence GHFE	Product Use Sequence HEGF	Total
Arm/Group Description	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 12-hour washout period 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). Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine	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 12-hour washout period 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). Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine	Same as previous arm, but in a different randomization order. Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine	Total of all reporting groups
Overall Participants	4	5	5	5	5	5	5	5	39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.3 (15.8)	49.0 (4.9)	38.0 (9.2)	32.6 (7.2)	36.4 (7.0)	40.8 (8.7)	46.4 (10.0)	50.0 (6.4)	41.8 (10.0)
Sex: Female, Male (Count of Participants)
Female	1 25%	1 20%	1 20%	1 20%	2 40%	2 40%	3 60%	3 60%	14 35.9%
Male	3 75%	4 80%	4 80%	4 80%	3 60%	3 60%	2 40%	2 40%	25 64.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 25%	1 20%	2 40%	3 60%	1 20%	0 0%	1 20%	0 0%	9 23.1%
Not Hispanic or Latino	3 75%	4 80%	3 60%	2 40%	4 80%	5 100%	4 80%	5 100%	30 76.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Body mass index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.8 (4.2)	30.5 (5.5)	28.2 (5.0)	26.1 (4.1)	29.4 (4.4)	29.7 (7.7)	28.5 (4.2)	28.7 (6.3)	28.4 (5.1)

Outcome Measures

1. Primary Outcome

Title	Maximum Nicotine Concentration in Blood
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Product Variant A	Product Variant B	Product Variant C	Product Variant D	Product Variant E	Product Variant F	Product Variant G	Product Variant H
Arm/Group Description	MyBlu e-cigarette variant A (2.4% nicotine)	MyBlu e- igarette variant B (2.4% nicotine)	MyBlu e-cigarette variant C (2.4% nicotine)	MyBlu e-cigarette variant D (2.4% nicotine)	MyBlu e- cigarette variant E (1.2% nicotine)	MyBlu e-cigarette variant F (1.2% nicotine)	MyBlu e-cigarette variant G (2.4% nicotine)	MyBlu e-cigarette variant H (2.4% nicotine)
Measure Participants	14	14	15	17	20	20	20	20
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	6.6 (137.5)	7.9 (91.8)	5.6 (107.2)	6.0 (184.5)	2.6 (88.7)	2.7 (91.4)	4.4 (94.4)	3.5 (295.6)

2. Primary Outcome

Title	Concentration of Carboxyhemoglobin in Blood
Description	Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.
Time Frame	Baseline and 8 days

Outcome Measure Data

Analysis Population Description

Data is missing for 3 participants at the 8 days timepoint

Arm/Group Title	Exclusive MyBlu E-cigarette Use
Arm/Group Description	Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants	38
Baseline value	5.4 (1.8)
Change from baseline	-4.0 (1.8)

3. Primary Outcome

Title	Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
Description	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

Outcome Measure Data

Analysis Population Description

Data is missing for 3 participants at the 8 days timepoint

Arm/Group Title	Exclusive MyBlu E-cigarette Use
Arm/Group Description	Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants	38
Baseline value	176.2 (87.4)
Change from baseline	-134.8 (66.5)

4. Primary Outcome

Title	Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
Description	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

Outcome Measure Data

Analysis Population Description

Data is missing for 3 participants at the 8 days timepoint

Arm/Group Title	Exclusive MyBlu E-cigarette Use
Arm/Group Description	Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants	38
Baseline value	756.2 (279.3)
Change from baseline	-599.3 (276.6)

5. Primary Outcome

Title	Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
Description	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

Outcome Measure Data

Analysis Population Description

Data is missing for 3 participants at the 8 days timepoint

Arm/Group Title	Exclusive MyBlu E-cigarette Use
Arm/Group Description	Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants	38
Baseline value	2.6 (1.4)
Change from baseline	-2.5 (1.4)

6. Secondary Outcome

Title	Level of White Blood Cells
Description	The change from baseline in the level of white blood cells, a biomarker of potential harm.
Time Frame	Baseline and 8 days

Outcome Measure Data

Analysis Population Description

Data is missing for 3 participants at the 8 days timepoint

Arm/Group Title	Exclusive MyBlu E-cigarette Use
Arm/Group Description	Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants	38
Baseline value	6.9 (1.5)
Change from baseline	-0.6 (1.0)

7. Secondary Outcome

Title	Spirometry: Forced Expiratory Volume in 1 Second
Description	The percent-predicted 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

Outcome Measure Data

Analysis Population Description

Data is missing for 3 participants at the 8 days timepoint

Arm/Group Title	Exclusive MyBlu E-cigarette Use
Arm/Group Description	Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants	38
Baseline value	98.0 (14.6)
8 days timepoint	98.6 (16.2)

8. Secondary Outcome

Title	Spirometry: Forced Vital Capacity
Description	The percent-predicted 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

Outcome Measure Data

Analysis Population Description

Data is missing for 3 participants at the 8 days timepoint

Arm/Group Title	Exclusive MyBlu E-cigarette Use
Arm/Group Description	Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants	38
Baseline value	101.0 (14.6)
8 days timepoint	100.3 (16.0)

9. Secondary Outcome

Title	Subjective Measure: Urge to Smoke
Description	Urge to smoke score: Subjects answer the following question "How strong is your urge to smoke right now?" using a visual analogue scale. 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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Product Variant A	Product Variant B	Product Variant C	Product Variant D	Product Variant E	Product Variant F	Product Variant G	Product Variant H
Arm/Group Description	MyBlu e-cigarette variant A (2.4% nicotine)	MyBlu e- igarette variant B (2.4% nicotine)	MyBlu e-cigarette variant C (2.4% nicotine)	MyBlu e-cigarette variant D (2.4% nicotine)	MyBlu e- cigarette variant E (1.2% nicotine)	MyBlu e-cigarette variant F (1.2% nicotine)	MyBlu e-cigarette variant G (2.4% nicotine)	MyBlu e-cigarette variant H (2.4% nicotine)
Measure Participants	16	15	14	17	20	20	20	20
Mean (Standard Deviation) [score on a scale]	72.3 (21.9)	76.4 (13.8)	64.9 (23.4)	67.6 (26.0)	53.7 (32.6)	54.4 (29.5)	55.4 (29.9)	59.0 (31.5)

Adverse Events

Time Frame	9 days
Arm/Group Title	Product Variant A		Product Variant B		Product Variant C		Product Variant D		Product Variant E		Product Variant F		Product Variant G		Product Variant H
Arm/Group Description	MyBlu e-cigarette variant A (2.4% nicotine)		MyBlu e- igarette variant B (2.4% nicotine)		MyBlu e-cigarette variant C (2.4% nicotine)		MyBlu e-cigarette variant D (2.4% nicotine)		MyBlu e- cigarette variant E (1.2% nicotine)		MyBlu e-cigarette variant F (1.2% nicotine)		MyBlu e-cigarette variant G (2.4% nicotine)		MyBlu e-cigarette variant H (2.4% nicotine)
All Cause Mortality
	Product Variant A		Product Variant B		Product Variant C		Product Variant D		Product Variant E		Product Variant F		Product Variant G		Product Variant H
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)		0/16 (0%)		0/18 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Product Variant A		Product Variant B		Product Variant C		Product Variant D		Product Variant E		Product Variant F		Product Variant G		Product Variant H
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)		0/16 (0%)		0/18 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Product Variant A		Product Variant B		Product Variant C		Product Variant D		Product Variant E		Product Variant F		Product Variant G		Product Variant H
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/18 (16.7%)		1/16 (6.3%)		1/16 (6.3%)		1/18 (5.6%)		2/20 (10%)		1/20 (5%)		0/20 (0%)		1/20 (5%)
Gastrointestinal disorders
Constipation	0/18 (0%)		1/16 (6.3%)		0/16 (0%)		0/18 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Diarrhea	0/18 (0%)		0/16 (0%)		0/16 (0%)		0/18 (0%)		0/20 (0%)		1/20 (5%)		0/20 (0%)		0/20 (0%)
Nervous system disorders
Headache	1/18 (5.6%)		0/16 (0%)		0/16 (0%)		0/18 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		1/20 (5%)
Hypoesthesia	1/18 (5.6%)		0/16 (0%)		0/16 (0%)		0/18 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Migraine	0/18 (0%)		0/16 (0%)		0/16 (0%)		1/18 (5.6%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Reproductive system and breast disorders
Dysmenorrhea	0/18 (0%)		0/16 (0%)		0/16 (0%)		0/18 (0%)		2/20 (10%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort	1/18 (5.6%)		0/16 (0%)		0/16 (0%)		0/18 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Skin and subcutaneous tissue disorders
Contact dermitits	0/18 (0%)		0/16 (0%)		1/16 (6.3%)		0/18 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.