Healthy VolunteersNCT04430634

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

A study testing Myblu variant A, Myblu variant B and Myblu variant C in people with Healthy Volunteers, run by Fontem US LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Myblu variant A, Myblu variant B and Myblu variant C
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2019to 31 Jan 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Lincoln, Nebraska, 68502

Other trials in United States

About this study

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

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: Healthy Volunteers
Being tested: Myblu variant A, Myblu variant B, Myblu variant C, Myblu variant D, Myblu variant E

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Myblu variant AOther
Use of Myblu e-cigarette with flavor A 2.4% nicotine
Myblu variant BOther
Use of Myblu e-cigarette with flavor B 3.6% nicotine
Myblu variant COther
Use of Myblu e-cigarette with flavor C 2.5% nicotine
Myblu variant DOther
Use of Myblu e-cigarette with flavor D 4.0% nicotine
Myblu variant EOther
Use of Myblu e-cigarette with flavor E 3.6% nicotine
Myblu variant FOther
Use of Myblu e-cigarette with flavor F 2.4% nicotine
Myblu variant GOther
Use of Myblu e-cigarette with flavor G 4.0% nicotine
Myblu variant HOther
Use of Myblu e-cigarette with flavor H 3.6% nicotine

Study groups in NCT04430634
Study group	Role	What they receive
ABDC	Experimental	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 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). Receives: Other: Myblu variant A; Other: Myblu variant B; Other: Myblu variant C; Other: Myblu variant D
BCAD	Experimental	Same as previous arm, but in a different randomization order. Receives: Other: Myblu variant A; Other: Myblu variant B; Other: Myblu variant C; Other: Myblu variant D
CDBA	Experimental	Same as previous arm, but in a different randomization order. Receives: Other: Myblu variant A; Other: Myblu variant B; Other: Myblu variant C; Other: Myblu variant D
DACB	Experimental	Same as previous arm, but in a different randomization order. Receives: Other: Myblu variant A; Other: Myblu variant B; Other: Myblu variant C; Other: Myblu variant D
EFHG	Experimental	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 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). Receives: Other: Myblu variant E; Other: Myblu variant F; Other: Myblu variant G; Other: Myblu variant H
FGEH	Experimental	Same as previous arm, but in a different randomization order. Receives: Other: Myblu variant E; Other: Myblu variant F; Other: Myblu variant G; Other: Myblu variant H
GHFE	Experimental	Same as previous arm, but in a different randomization order. Receives: Other: Myblu variant E; Other: Myblu variant F; Other: Myblu variant G; Other: Myblu variant H
HEGF	Experimental	Same as previous arm, but in a different randomization order. Receives: Other: Myblu variant E; Other: Myblu variant F; Other: Myblu variant G; Other: Myblu variant H

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Nicotine Concentration in Blood
Maximum nicotine concentration in blood (Cmax)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and 8 days

Secondary outcomes (4)

Level of White Blood Cells
The change from baseline in the level of white blood cells, a biomarker of potential harm.
Measured: Baseline and 8 days
Spirometry: Forced Expiratory Volume in 1 Second
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.
Measured: Baseline and 8 days
Spirometry: Forced Vital Capacity
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.
Measured: 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 (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.
Measured: 8 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201931 Jan 2020

First posted12 Jun 2020
Study start1 Nov 2019
Primary completion31 Jan 2020
Study completion31 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04430634
Sponsor's protocol ID: CA22749
Status last verified: May 2021
First submitted: 10 Jun 2020
Last updated: 7 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04430634
Acronym / sponsor ID: CA22749
Conditions: Healthy Volunteers
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Fontem US LLCIndustry (pharma, biotech, devices)
Collaborators: Fontem Ventures BV
Study start: 1 Nov 2019 (actual)
Primary completion: 31 Jan 2020 (actual)
Study completion: 31 Jan 2020 (actual)
First posted: 12 Jun 2020 (actual)
Results: Posted 7 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
ABDC	Experimental	Other: Myblu variant A, Other: Myblu variant B, Other: Myblu variant C, Other: Myblu variant DSubjects 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 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).
BCAD	Experimental	Other: Myblu variant A, Other: Myblu variant B, Other: Myblu variant C, Other: Myblu variant DSame as previous arm, but in a different randomization order.
CDBA	Experimental	Other: Myblu variant A, Other: Myblu variant B, Other: Myblu variant C, Other: Myblu variant DSame as previous arm, but in a different randomization order.
DACB	Experimental	Other: Myblu variant A, Other: Myblu variant B, Other: Myblu variant C, Other: Myblu variant DSame as previous arm, but in a different randomization order.
EFHG	Experimental	Other: Myblu variant E, Other: Myblu variant F, Other: Myblu variant G, Other: Myblu variant HSubjects 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 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).
FGEH	Experimental	Other: Myblu variant E, Other: Myblu variant F, Other: Myblu variant G, Other: Myblu variant HSame as previous arm, but in a different randomization order.
GHFE	Experimental	Other: Myblu variant E, Other: Myblu variant F, Other: Myblu variant G, Other: Myblu variant HSame as previous arm, but in a different randomization order.
HEGF	Experimental	Other: Myblu variant E, Other: Myblu variant F, Other: Myblu variant G, Other: Myblu variant HSame as previous arm, but in a different randomization order.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Myblu variant AUse of Myblu e-cigarette with flavor A 2.4% nicotine	Other	ABDC, BCAD, CDBA, DACB
Myblu variant BUse of Myblu e-cigarette with flavor B 3.6% nicotine	Other	ABDC, BCAD, CDBA, DACB
Myblu variant CUse of Myblu e-cigarette with flavor C 2.5% nicotine	Other	ABDC, BCAD, CDBA, DACB
Myblu variant DUse of Myblu e-cigarette with flavor D 4.0% nicotine	Other	ABDC, BCAD, CDBA, DACB
Myblu variant EUse of Myblu e-cigarette with flavor E 3.6% nicotine	Other	EFHG, FGEH, GHFE, HEGF
Myblu variant FUse of Myblu e-cigarette with flavor F 2.4% nicotine	Other	EFHG, FGEH, GHFE, HEGF
Myblu variant GUse of Myblu e-cigarette with flavor G 4.0% nicotine	Other	EFHG, FGEH, GHFE, HEGF
Myblu variant HUse of Myblu e-cigarette with flavor H 3.6% nicotine	Other	EFHG, FGEH, GHFE, HEGF

Primary outcome

Maximum Nicotine Concentration in Blood
Time frame: 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)
Concentration of Carboxyhemoglobin in Blood
Time frame: 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
Time frame: 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).
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
Time frame: 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
Time frame: 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).

4 secondary outcomes

Level of White Blood Cells
Time frame: Baseline and 8 days
Spirometry: Forced Expiratory Volume in 1 Second
Time frame: Baseline and 8 days
Spirometry: Forced Vital Capacity
Time frame: Baseline and 8 days
Subjective Measure: Urge to Smoke
Time frame: 8 days

Results and safety

Results posted to the registry on 7 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABDC	5	5
BCAD	5	5
CDBA	5	5
DACB	5	4
EFHG	5	5
FGEH	5	5
GHFE	5	4
HEGF	5	5

Primary outcome: Maximum Nicotine Concentration in Blood

Time frame: 180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Product Variant A n = 19	Product Variant B n = 18	Product Variant C n = 19	Product Variant D n = 18	Product Variant E n = 18	Product Variant F n = 19	Product Variant G n = 19	Product Variant H n = 18
Value	3.6 (91.6)	5.3 (109.6)	4.0 (113.5)	5.3 (106.4)	6.5 (135.7)	4.6 (143.4)	8.0 (99.6)	9.3 (95.8)

Primary outcome: Concentration of Carboxyhemoglobin in Blood

Time frame: Baseline and 8 days. Mean (Standard Deviation). Unit: % saturation

Measure	Exclusive MyBlu E-cigarette Use n = 39
Baseline value	7.7 (2.1)
Change from baseline	-6.25 (2.06)

Population analysed: 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.

Primary outcome: Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours

Time frame: Baseline and 8 days. Mean (Standard Deviation). Unit: ng/g creatinine

Measure	Exclusive MyBlu E-cigarette Use n = 39
Baseline value	345.4 (252.3)
Change from baseline	-262.8 (205.1)

Primary outcome: Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours

Time frame: Baseline and 8 days. Mean (Standard Deviation). Unit: ug/g creatinine

Measure	Exclusive MyBlu E-cigarette Use n = 39
Baseline value	1242.2 (536.0)
Change from baseline	-1097.1 (522.2)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Product Variant A	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19
Product Variant B	0 of 19 (0%)	4 of 19 (21.1%)	0 of 19
Product Variant C	0 of 19 (0%)	3 of 19 (15.8%)	0 of 19
Product Variant D	0 of 20 (0%)	2 of 20 (10%)	0 of 20
Product Variant E	0 of 19 (0%)	3 of 19 (15.8%)	0 of 19
Product Variant F	0 of 19 (0%)	2 of 19 (10.5%)	0 of 19
Product Variant G	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Product Variant H	0 of 20 (0%)	3 of 20 (15%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34435305Morris 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Myblu variant A, Myblu variant B and Myblu variant C in people with Healthy Volunteers, run by Fontem US LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Nicotine Concentration in Blood (time frame: 180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04430634, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.