Trial Outcomes & Findings for A Study to Evaluate Nicotine Uptake and Biomarkers in Adult Smokers Using mybluTM Electronic Cigarettes (NCT NCT04429932)

Results Overview

Maximum nicotine concentration in blood (Cmax)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)

Results posted on

2021-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	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 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	Product Use Sequence BCAD 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	Product Use Sequence CDBA 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	Product Use Sequence DACB 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	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 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	Product Use Sequence FGEH 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	Product Use Sequence GHFE 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	Product Use Sequence HEGF 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
Overall Study STARTED	4	5	5	5	5	5	5	5
Overall Study COMPLETED	3	5	5	2	5	5	5	5
Overall Study NOT COMPLETED	1	0	0	3	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Product Use Sequence ABDC n=4 Participants 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	Product Use Sequence BCAD n=5 Participants 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	Product Use Sequence CDBA n=5 Participants 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	Product Use Sequence DACB n=5 Participants 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	Product Use Sequence EFHG n=5 Participants 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	Product Use Sequence FGEH n=5 Participants 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	Product Use Sequence GHFE n=5 Participants 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	Product Use Sequence HEGF n=5 Participants 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 n=39 Participants Total of all reporting groups
Age, Continuous	41.3 years STANDARD_DEVIATION 15.8 • n=99 Participants	49.0 years STANDARD_DEVIATION 4.9 • n=107 Participants	38.0 years STANDARD_DEVIATION 9.2 • n=206 Participants	32.6 years STANDARD_DEVIATION 7.2 • n=7 Participants	36.4 years STANDARD_DEVIATION 7.0 • n=31 Participants	40.8 years STANDARD_DEVIATION 8.7 • n=30 Participants	46.4 years STANDARD_DEVIATION 10.0 • n=3 Participants	50.0 years STANDARD_DEVIATION 6.4 • n=6 Participants	41.8 years STANDARD_DEVIATION 10.0 • n=114 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants	2 Participants n=30 Participants	3 Participants n=3 Participants	3 Participants n=6 Participants	14 Participants n=114 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants	4 Participants n=7 Participants	3 Participants n=31 Participants	3 Participants n=30 Participants	2 Participants n=3 Participants	2 Participants n=6 Participants	25 Participants n=114 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants	1 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants	0 Participants n=6 Participants	9 Participants n=114 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants	4 Participants n=107 Participants	3 Participants n=206 Participants	2 Participants n=7 Participants	4 Participants n=31 Participants	5 Participants n=30 Participants	4 Participants n=3 Participants	5 Participants n=6 Participants	30 Participants n=114 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants
Body mass index (BMI)	25.8 kg/m^2 STANDARD_DEVIATION 4.2 • n=99 Participants	30.5 kg/m^2 STANDARD_DEVIATION 5.5 • n=107 Participants	28.2 kg/m^2 STANDARD_DEVIATION 5.0 • n=206 Participants	26.1 kg/m^2 STANDARD_DEVIATION 4.1 • n=7 Participants	29.4 kg/m^2 STANDARD_DEVIATION 4.4 • n=31 Participants	29.7 kg/m^2 STANDARD_DEVIATION 7.7 • n=30 Participants	28.5 kg/m^2 STANDARD_DEVIATION 4.2 • n=3 Participants	28.7 kg/m^2 STANDARD_DEVIATION 6.3 • n=6 Participants	28.4 kg/m^2 STANDARD_DEVIATION 5.1 • n=114 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Product Variant A n=14 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B n=14 Participants MyBlu e- igarette variant B (2.4% nicotine)	Product Variant C n=15 Participants MyBlu e-cigarette variant C (2.4% nicotine)	Product Variant D n=17 Participants MyBlu e-cigarette variant D (2.4% nicotine)	Product Variant E n=20 Participants MyBlu e- cigarette variant E (1.2% nicotine)	Product Variant F n=20 Participants MyBlu e-cigarette variant F (1.2% nicotine)	Product Variant G n=20 Participants MyBlu e-cigarette variant G (2.4% nicotine)	Product Variant H n=20 Participants MyBlu e-cigarette variant H (2.4% nicotine)
Maximum Nicotine Concentration in Blood	6.6 ng/mL Geometric Coefficient of Variation 137.5	7.9 ng/mL Geometric Coefficient of Variation 91.8	5.6 ng/mL Geometric Coefficient of Variation 107.2	6.0 ng/mL Geometric Coefficient of Variation 184.5	2.6 ng/mL Geometric Coefficient of Variation 88.7	2.7 ng/mL Geometric Coefficient of Variation 91.4	4.4 ng/mL Geometric Coefficient of Variation 94.4	3.5 ng/mL Geometric Coefficient of Variation 295.6

PRIMARY outcome

Timeframe: Baseline and 8 days

Population: Data is missing for 3 participants at the 8 days timepoint

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

Outcome measures

Outcome measures
Measure	Product Variant A n=38 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e- igarette variant B (2.4% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.4% nicotine)	Product Variant D MyBlu e-cigarette variant D (2.4% nicotine)	Product Variant E MyBlu e- cigarette variant E (1.2% nicotine)	Product Variant F MyBlu e-cigarette variant F (1.2% nicotine)	Product Variant G MyBlu e-cigarette variant G (2.4% nicotine)	Product Variant H MyBlu e-cigarette variant H (2.4% nicotine)
Concentration of Carboxyhemoglobin in Blood Change from baseline	-4.0 % saturation Standard Deviation 1.8	—	—	—	—	—	—	—
Concentration of Carboxyhemoglobin in Blood Baseline value	5.4 % saturation Standard Deviation 1.8	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 8 days

Population: Data is missing for 3 participants at the 8 days timepoint

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).

Outcome measures

Outcome measures
Measure	Product Variant A n=38 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e- igarette variant B (2.4% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.4% nicotine)	Product Variant D MyBlu e-cigarette variant D (2.4% nicotine)	Product Variant E MyBlu e- cigarette variant E (1.2% nicotine)	Product Variant F MyBlu e-cigarette variant F (1.2% nicotine)	Product Variant G MyBlu e-cigarette variant G (2.4% nicotine)	Product Variant H MyBlu e-cigarette variant H (2.4% nicotine)
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours Baseline value	176.2 ng/g creatinine Standard Deviation 87.4	—	—	—	—	—	—	—
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours Change from baseline	-134.8 ng/g creatinine Standard Deviation 66.5	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 8 days

Population: Data is missing for 3 participants at the 8 days timepoint

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).

Outcome measures

Outcome measures
Measure	Product Variant A n=38 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e- igarette variant B (2.4% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.4% nicotine)	Product Variant D MyBlu e-cigarette variant D (2.4% nicotine)	Product Variant E MyBlu e- cigarette variant E (1.2% nicotine)	Product Variant F MyBlu e-cigarette variant F (1.2% nicotine)	Product Variant G MyBlu e-cigarette variant G (2.4% nicotine)	Product Variant H MyBlu e-cigarette variant H (2.4% nicotine)
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours Baseline value	756.2 ug/g creatinine Standard Deviation 279.3	—	—	—	—	—	—	—
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours Change from baseline	-599.3 ug/g creatinine Standard Deviation 276.6	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 8 days

Population: Data is missing for 3 participants at the 8 days timepoint

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).

Outcome measures

Outcome measures
Measure	Product Variant A n=38 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e- igarette variant B (2.4% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.4% nicotine)	Product Variant D MyBlu e-cigarette variant D (2.4% nicotine)	Product Variant E MyBlu e- cigarette variant E (1.2% nicotine)	Product Variant F MyBlu e-cigarette variant F (1.2% nicotine)	Product Variant G MyBlu e-cigarette variant G (2.4% nicotine)	Product Variant H MyBlu e-cigarette variant H (2.4% nicotine)
Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours Baseline value	2.6 ug/g creatinine Standard Deviation 1.4	—	—	—	—	—	—	—
Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours Change from baseline	-2.5 ug/g creatinine Standard Deviation 1.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 days

Population: Data is missing for 3 participants at the 8 days timepoint

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

Outcome measures

Outcome measures
Measure	Product Variant A n=38 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e- igarette variant B (2.4% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.4% nicotine)	Product Variant D MyBlu e-cigarette variant D (2.4% nicotine)	Product Variant E MyBlu e- cigarette variant E (1.2% nicotine)	Product Variant F MyBlu e-cigarette variant F (1.2% nicotine)	Product Variant G MyBlu e-cigarette variant G (2.4% nicotine)	Product Variant H MyBlu e-cigarette variant H (2.4% nicotine)
Level of White Blood Cells Baseline value	6.9 cells*10^9/L Standard Deviation 1.5	—	—	—	—	—	—	—
Level of White Blood Cells Change from baseline	-0.6 cells*10^9/L Standard Deviation 1.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 days

Population: Data is missing for 3 participants at the 8 days timepoint

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.

Outcome measures

Outcome measures
Measure	Product Variant A n=38 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e- igarette variant B (2.4% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.4% nicotine)	Product Variant D MyBlu e-cigarette variant D (2.4% nicotine)	Product Variant E MyBlu e- cigarette variant E (1.2% nicotine)	Product Variant F MyBlu e-cigarette variant F (1.2% nicotine)	Product Variant G MyBlu e-cigarette variant G (2.4% nicotine)	Product Variant H MyBlu e-cigarette variant H (2.4% nicotine)
Spirometry: Forced Expiratory Volume in 1 Second Baseline value	98.0 Percent-predicted FEV1 Standard Deviation 14.6	—	—	—	—	—	—	—
Spirometry: Forced Expiratory Volume in 1 Second 8 days timepoint	98.6 Percent-predicted FEV1 Standard Deviation 16.2	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 days

Population: Data is missing for 3 participants at the 8 days timepoint

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.

Outcome measures

Outcome measures
Measure	Product Variant A n=38 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e- igarette variant B (2.4% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.4% nicotine)	Product Variant D MyBlu e-cigarette variant D (2.4% nicotine)	Product Variant E MyBlu e- cigarette variant E (1.2% nicotine)	Product Variant F MyBlu e-cigarette variant F (1.2% nicotine)	Product Variant G MyBlu e-cigarette variant G (2.4% nicotine)	Product Variant H MyBlu e-cigarette variant H (2.4% nicotine)
Spirometry: Forced Vital Capacity Baseline value	101.0 Percent-predicted FVC Standard Deviation 14.6	—	—	—	—	—	—	—
Spirometry: Forced Vital Capacity 8 days timepoint	100.3 Percent-predicted FVC Standard Deviation 16.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.