CompletedNCT04429932Updated Jun 7, 2021Results posted

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

An interventional study of Myblu flavor A_2.4 and Myblu flavor B_2.4 in Healthy Volunteers, sponsored by Fontem US LLC. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-07.

Sponsored by Fontem US LLC · Not applicable, Interventional, and Other

From the registry’s dates

Registered 6 months after the study started (first participant enrolled Dec 2019, registered Jun 2020).

Phase: Not applicable
Study type: Interventional
Enrollment: 39
Allocation: Randomized
Ages: 21 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Healthy Volunteers

In context

Lead sponsor

Fontem US LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 65 Years
Sexes eligible: 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

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

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 39 participants (actual)

Study arms

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 · Other: Myblu flavor B_2.4 · Other: Myblu flavor C_2.4 · Other: Myblu flavor D_2.4
Experimental
Product use sequence BCAD
Same as previous arm, but in a different randomization order.
Other: Myblu flavor A_2.4 · Other: Myblu flavor B_2.4 · Other: Myblu flavor C_2.4 · Other: Myblu flavor D_2.4
Experimental
Product use sequence CDBA
Same as previous arm, but in a different randomization order.
Other: Myblu flavor A_2.4 · Other: Myblu flavor C_2.4 · Other: Myblu flavor D_2.4
Experimental
Product use sequence DACB
Same as previous arm, but in a different randomization order.
Other: Myblu flavor A_2.4 · Other: Myblu flavor B_2.4 · Other: Myblu flavor C_2.4 · Other: Myblu flavor D_2.4
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 · Other: Myblu flavor F_1.2 · Other: Myblu flavor G_2.4 · Other: Myblu flavor H_2.4
Experimental
Product use sequence FGEH
Same as previous arm, but in a different randomization order.
Other: Myblu flavor E_1.2 · Other: Myblu flavor F_1.2 · Other: Myblu flavor G_2.4 · Other: Myblu flavor H_2.4
Experimental
Product use sequence GHFE
Same as previous arm, but in a different randomization order.
Other: Myblu flavor E_1.2 · Other: Myblu flavor F_1.2 · Other: Myblu flavor G_2.4 · Other: Myblu flavor H_2.4
Experimental
Product use sequence HEGF
Same as previous arm, but in a different randomization order.
Other: Myblu flavor E_1.2 · Other: Myblu flavor F_1.2 · Other: Myblu flavor G_2.4 · Other: Myblu flavor H_2.4

Interventions

OtherMyblu flavor A_2.4
Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine
OtherMyblu flavor B_2.4
Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine
OtherMyblu flavor C_2.4
Use of Myblu e-cigarette with flavor C at 2.4% nicotine
OtherMyblu flavor D_2.4
Use of Myblu e-cigarette with flavor D at 2.4% nicotine
OtherMyblu flavor E_1.2
Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine
OtherMyblu flavor F_1.2
Fse of Myblu e-cigarette with flavor F at 1.2% nicotine
OtherMyblu flavor G_2.4
Use of Myblu e-cigarette with flavor G at 2.4% nicotine
OtherMyblu flavor H_2.4
Use of Myblu e-cigarette with flavor H at 2.4% nicotine

What researchers measure

Primary outcomes

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

Secondary outcomes

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
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
Spirometry: Forced Vital Capacity
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
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. 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

Results

Posted Jun 7, 2021

Participant flow

Participant flow — Overall Study
Milestone	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
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

Outcome measures

PrimaryMaximum 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)
Reported as:: Geometric mean · ng/mL

Maximum Nicotine Concentration in Blood
ng/mL	Product Variant A	Product Variant B	Product Variant C	Product Variant D	Product Variant E	Product Variant F	Product Variant G	Product Variant H
Maximum Nicotine Concentration in Blood	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

PrimaryConcentration of Carboxyhemoglobin in Blood

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

Time frame:: Baseline and 8 days
Reported as:: Mean · % saturation

Concentration of Carboxyhemoglobin in Blood
% saturation	Exclusive MyBlu E-cigarette Use
Baseline value	5.4 ± 1.8
Change from baseline	-4.0 ± 1.8

PrimaryAmount 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
Reported as:: Mean · ng/g creatinine

Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
ng/g creatinine	Exclusive MyBlu E-cigarette Use
Baseline value	176.2 ± 87.4
Change from baseline	-134.8 ± 66.5

PrimaryAmount 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
Reported as:: Mean · ug/g creatinine

Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
ug/g creatinine	Exclusive MyBlu E-cigarette Use
Baseline value	756.2 ± 279.3
Change from baseline	-599.3 ± 276.6

PrimaryAmount 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
Reported as:: Mean · ug/g creatinine

Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
ug/g creatinine	Exclusive MyBlu E-cigarette Use
Baseline value	2.6 ± 1.4
Change from baseline	-2.5 ± 1.4

SecondaryLevel 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
Reported as:: Mean · cells*10^9/L

Level of White Blood Cells
cells*10^9/L	Exclusive MyBlu E-cigarette Use
Baseline value	6.9 ± 1.5
Change from baseline	-0.6 ± 1.0

SecondarySpirometry: Forced Expiratory Volume in 1 Second

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
Reported as:: Mean · Percent-predicted FEV1

Spirometry: Forced Expiratory Volume in 1 Second
Percent-predicted FEV1	Exclusive MyBlu E-cigarette Use
Baseline value	98.0 ± 14.6
8 days timepoint	98.6 ± 16.2

SecondarySpirometry: Forced Vital Capacity

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
Reported as:: Mean · Percent-predicted FVC

Spirometry: Forced Vital Capacity
Percent-predicted FVC	Exclusive MyBlu E-cigarette Use
Baseline value	101.0 ± 14.6
8 days timepoint	100.3 ± 16.0

SecondarySubjective 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. 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
Reported as:: Mean · score on a scale

Subjective Measure: Urge to Smoke
score on a scale	Product Variant A	Product Variant B	Product Variant C	Product Variant D	Product Variant E	Product Variant F	Product Variant G	Product Variant H
Subjective Measure: Urge to Smoke	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

Collected over 9 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Product Variant A	0/18 (0%)	0/18 (0%)	3/18 (16.7%)
Product Variant B	0/16 (0%)	0/16 (0%)	1/16 (6.3%)
Product Variant C	0/16 (0%)	0/16 (0%)	1/16 (6.3%)
Product Variant D	0/18 (0%)	0/18 (0%)	1/18 (5.6%)
Product Variant E	0/20 (0%)	0/20 (0%)	2/20 (10%)
Product Variant F	0/20 (0%)	0/20 (0%)	1/20 (5%)
Product Variant G	0/20 (0%)	0/20 (0%)	0/20 (0%)
Product Variant H	0/20 (0%)	0/20 (0%)	1/20 (5%)

Most frequent other events

Most frequent other events
Event	Product Variant A	Product Variant B	Product Variant C	Product Variant D	Product Variant E	Product Variant F	Product Variant G	Product Variant H
DysmenorrheaReproductive system and breast disorders	0/18	0/16	0/16	0/18	2/20	0/20	0/20	0/20
ConstipationGastrointestinal disorders	0/18	1/16	0/16	0/18	0/20	0/20	0/20	0/20
Contact dermititsSkin and subcutaneous tissue disorders	0/18	0/16	1/16	0/18	0/20	0/20	0/20	0/20
HeadacheNervous system disorders	1/18	0/16	0/16	0/18	0/20	0/20	0/20	1/20
HypoesthesiaNervous system disorders	1/18	0/16	0/16	0/18	0/20	0/20	0/20	0/20
MigraineNervous system disorders	0/18	0/16	0/16	1/18	0/20	0/20	0/20	0/20
Oropharyngeal discomfortRespiratory, thoracic and mediastinal disorders	1/18	0/16	0/16	0/18	0/20	0/20	0/20	0/20
DiarrheaGastrointestinal disorders	0/18	0/16	0/16	0/18	0/20	1/20	0/20	0/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)	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
Mean	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
Sex: Female, Male(Participants)	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
Female	1	1	1	1	2	2	3	3	14
Male	3	4	4	4	3	3	2	2	25

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	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
Hispanic or Latino	1	1	2	3	1	0	1	0	9
Not Hispanic or Latino	3	4	3	2	4	5	4	5	30
Unknown or Not Reported	0	0	0	0	0	0	0	0	0

Body mass index (BMI)
Body mass index (BMI)(kg/m^2)	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
Mean	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

Study locations

1 site

Celerion
Lincoln, Nebraska 68502, United States

References and documents

Publications

Morris P, McDermott S, Chapman F, Verron T, Cahours X, Stevenson M, Thompson J, Chaudhary N, O'Connell G. Reductions in biomarkers of exposure to selected harmful and potentially harmful constituents following exclusive and partial switching from combustible cigarettes to myblu electronic nicotine delivery systems (ENDS). Intern Emerg Med. 2022 Mar;17(2):397-410. doi: 10.1007/s11739-021-02813-w. Epub 2021 Aug 26. PubMed 34435305 ↗

Study documents

Study protocol · Dec 4, 2019
Statistical analysis plan · Feb 26, 2020

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04429932
Lead sponsor: Fontem US LLC
Collaborators: Fontem Ventures BV
Responsible party: Sponsor
First posted: Jun 12, 2020
Start date: Dec 1, 2019
Primary completion: Jan 31, 2020
Completion: Jan 31, 2020
Results posted: Jun 7, 2021
Last update: Jun 7, 2021

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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