Trial Outcomes & Findings for A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes (NCT NCT04430634)

NCT ID: NCT04430634

Last Updated: 2021-06-07

Results Overview

Maximum nicotine concentration in blood (Cmax)

Recruitment status

COMPLETED

Study phase

Target enrollment

40 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	ABDC Subjects use MybluTM e-cigarette product variant A (2.4 % nicotine) ad libitum for 2 days, then switch to use variant B (3.6% nicotine) for 2 days, then D (4.0% nicotine) for 2 days and then C (2.5% 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).	BCAD Same as previous but in a different randomization order	CDBA Same as previous but in a different randomization order	DACB Same as previous but in a different randomization order	EFHG Subjects use MybluTM e-cigarette product variant E (3.6 % nicotine) ad libitum for 2 days, then switch to use variant F (2.4% nicotine) for 2 days, then H (3.6% nicotine) for 2 days and then G (4.0% 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).	FGEH Same as previous but in a different randomization order	GHFE Same as previous but in a different randomization order	HEGF Same as previous but in a different randomization order
Overall Study STARTED	5	5	5	5	5	5	5	5
Overall Study COMPLETED	5	5	5	4	5	5	4	5
Overall Study NOT COMPLETED	0	0	0	1	0	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABDC n=5 Participants Subjects use MybluTM e-cigarette product variant A (2.4 % nicotine) ad libitum for 2 days, then switch to use variant B (3.6% nicotine) for 2 days, then D (4.0% nicotine) for 2 days and then C (2.5% 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).	BCAD n=5 Participants Same as previous but in a different randomization order	CDBA n=5 Participants Same as previous but in a different randomization order	DACB n=5 Participants Same as previous but in a different randomization order	EFHG n=5 Participants Subjects use MybluTM e-cigarette product variant E (3.6 % nicotine) ad libitum for 2 days, then switch to use variant F (2.4% nicotine) for 2 days, then H (3.6% nicotine) for 2 days and then G (4.0% 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).	FGEH n=5 Participants Same as previous but in a different randomization order	GHFE n=5 Participants Same as previous but in a different randomization order	HEGF n=5 Participants Same as previous but in a different randomization order	Total n=40 Participants Total of all reporting groups
Age, Continuous	46.0 years STANDARD_DEVIATION 15.28 • n=99 Participants	38.6 years STANDARD_DEVIATION 14.03 • n=107 Participants	47.6 years STANDARD_DEVIATION 8.73 • n=206 Participants	37.8 years STANDARD_DEVIATION 10.76 • n=7 Participants	44.6 years STANDARD_DEVIATION 10.88 • n=31 Participants	41.6 years STANDARD_DEVIATION 11.19 • n=30 Participants	43.0 years STANDARD_DEVIATION 11.51 • n=3 Participants	47.2 years STANDARD_DEVIATION 12.58 • n=6 Participants	43.3 years STANDARD_DEVIATION 11.45 • n=114 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants	1 Participants n=30 Participants	1 Participants n=3 Participants	4 Participants n=6 Participants	16 Participants n=114 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	4 Participants n=7 Participants	3 Participants n=31 Participants	4 Participants n=30 Participants	4 Participants n=3 Participants	1 Participants n=6 Participants	24 Participants n=114 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	1 Participants n=114 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=99 Participants	5 Participants n=107 Participants	5 Participants n=206 Participants	4 Participants n=7 Participants	5 Participants n=31 Participants	5 Participants n=30 Participants	5 Participants n=3 Participants	5 Participants n=6 Participants	39 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
BMI	25.8 kg/m^2 STANDARD_DEVIATION 4.5 • n=99 Participants	29.3 kg/m^2 STANDARD_DEVIATION 2.1 • n=107 Participants	29.4 kg/m^2 STANDARD_DEVIATION 5.5 • n=206 Participants	29.2 kg/m^2 STANDARD_DEVIATION 4.3 • n=7 Participants	26.4 kg/m^2 STANDARD_DEVIATION 7.3 • n=31 Participants	25.3 kg/m^2 STANDARD_DEVIATION 3.3 • n=30 Participants	28.2 kg/m^2 STANDARD_DEVIATION 3.7 • n=3 Participants	27.5 kg/m^2 STANDARD_DEVIATION 3.3 • n=6 Participants	27.6 kg/m^2 STANDARD_DEVIATION 4.4 • 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=19 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B n=18 Participants MyBlu e-cigarette variant B (3.6% nicotine)	Product Variant C n=19 Participants MyBlu e-cigarette variant C (2.5% nicotine)	Product Variant D n=18 Participants MyBlu e-cigarette variant D (4.0% nicotine)	Product Variant E n=18 Participants MyBlu e-cigarette variant E (3.6% nicotine)	Product Variant F n=19 Participants MyBlu e-cigarette variant F (2.4% nicotine)	Product Variant G n=19 Participants MyBlu e-cigarette variant G (4.0% nicotine)	Product Variant H n=18 Participants MyBlu e-cigarette variant H (3.6% nicotine)
Maximum Nicotine Concentration in Blood	3.6 ng/mL Geometric Coefficient of Variation 91.6	5.3 ng/mL Geometric Coefficient of Variation 109.6	4.0 ng/mL Geometric Coefficient of Variation 113.5	5.3 ng/mL Geometric Coefficient of Variation 106.4	6.5 ng/mL Geometric Coefficient of Variation 135.7	4.6 ng/mL Geometric Coefficient of Variation 143.4	8.0 ng/mL Geometric Coefficient of Variation 99.6	9.3 ng/mL Geometric Coefficient of Variation 95.8

PRIMARY outcome

Timeframe: Baseline and 8 days

Population: The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 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=39 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e-cigarette variant B (3.6% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.5% nicotine)	Product Variant D MyBlu e-cigarette variant D (4.0% nicotine)	Product Variant E MyBlu e-cigarette variant E (3.6% nicotine)	Product Variant F MyBlu e-cigarette variant F (2.4% nicotine)	Product Variant G MyBlu e-cigarette variant G (4.0% nicotine)	Product Variant H MyBlu e-cigarette variant H (3.6% nicotine)
Concentration of Carboxyhemoglobin in Blood Baseline value	7.7 % saturation Standard Deviation 2.1	—	—	—	—	—	—	—
Concentration of Carboxyhemoglobin in Blood Change from baseline	-6.25 % saturation Standard Deviation 2.06	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Product Variant A n=39 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e-cigarette variant B (3.6% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.5% nicotine)	Product Variant D MyBlu e-cigarette variant D (4.0% nicotine)	Product Variant E MyBlu e-cigarette variant E (3.6% nicotine)	Product Variant F MyBlu e-cigarette variant F (2.4% nicotine)	Product Variant G MyBlu e-cigarette variant G (4.0% nicotine)	Product Variant H MyBlu e-cigarette variant H (3.6% nicotine)
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours Baseline value	345.4 ng/g creatinine Standard Deviation 252.3	—	—	—	—	—	—	—
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours Change from baseline	-262.8 ng/g creatinine Standard Deviation 205.1	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Product Variant A n=39 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e-cigarette variant B (3.6% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.5% nicotine)	Product Variant D MyBlu e-cigarette variant D (4.0% nicotine)	Product Variant E MyBlu e-cigarette variant E (3.6% nicotine)	Product Variant F MyBlu e-cigarette variant F (2.4% nicotine)	Product Variant G MyBlu e-cigarette variant G (4.0% nicotine)	Product Variant H MyBlu e-cigarette variant H (3.6% nicotine)
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours Baseline value	1242.2 ug/g creatinine Standard Deviation 536.0	—	—	—	—	—	—	—
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours Change from baseline	-1097.1 ug/g creatinine Standard Deviation 522.2	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Product Variant A n=39 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e-cigarette variant B (3.6% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.5% nicotine)	Product Variant D MyBlu e-cigarette variant D (4.0% nicotine)	Product Variant E MyBlu e-cigarette variant E (3.6% nicotine)	Product Variant F MyBlu e-cigarette variant F (2.4% nicotine)	Product Variant G MyBlu e-cigarette variant G (4.0% nicotine)	Product Variant H MyBlu e-cigarette variant H (3.6% nicotine)
Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours Baseline value	5.9 ug/g creatinine Standard Deviation 4.2	—	—	—	—	—	—	—
Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours Change from baseline	-5.9 ug/g creatinine Standard Deviation 4.1	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 days

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=39 Participants MyBlu e-cigarette variant A (2.4% nicotine)	Product Variant B MyBlu e-cigarette variant B (3.6% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.5% nicotine)	Product Variant D MyBlu e-cigarette variant D (4.0% nicotine)	Product Variant E MyBlu e-cigarette variant E (3.6% nicotine)	Product Variant F MyBlu e-cigarette variant F (2.4% nicotine)	Product Variant G MyBlu e-cigarette variant G (4.0% nicotine)	Product Variant H MyBlu e-cigarette variant H (3.6% nicotine)
Level of White Blood Cells Baseline value	7.5 cells*10^9/L Standard Deviation 1.7	—	—	—	—	—	—	—
Level of White Blood Cells Change from baseline	-0.4 cells*10^9/L Standard Deviation 1.1	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 days

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-cigarette variant B (3.6% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.5% nicotine)	Product Variant D MyBlu e-cigarette variant D (4.0% nicotine)	Product Variant E MyBlu e-cigarette variant E (3.6% nicotine)	Product Variant F MyBlu e-cigarette variant F (2.4% nicotine)	Product Variant G MyBlu e-cigarette variant G (4.0% nicotine)	Product Variant H MyBlu e-cigarette variant H (3.6% nicotine)
Spirometry: Forced Expiratory Volume in 1 Second Baseline value	2.9 L Standard Deviation 1.2	—	—	—	—	—	—	—
Spirometry: Forced Expiratory Volume in 1 Second 8 days timepoint	3.2 L Standard Deviation 0.9	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 8 days

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-cigarette variant B (3.6% nicotine)	Product Variant C MyBlu e-cigarette variant C (2.5% nicotine)	Product Variant D MyBlu e-cigarette variant D (4.0% nicotine)	Product Variant E MyBlu e-cigarette variant E (3.6% nicotine)	Product Variant F MyBlu e-cigarette variant F (2.4% nicotine)	Product Variant G MyBlu e-cigarette variant G (4.0% nicotine)	Product Variant H MyBlu e-cigarette variant H (3.6% nicotine)
Spirometry: Forced Vital Capacity Baseline value	3.8 L Standard Deviation 1.5	—	—	—	—	—	—	—
Spirometry: Forced Vital Capacity 8 days timepoint	4.2 L Standard Deviation 1.2	—	—	—	—	—	—	—

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 (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.