A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes

Sponsor
Fontem Ventures BV (Industry)
Overall Status
Completed
CT.gov ID
NCT04019626
Collaborator
(none)
240
Enrollment
1
Location
6
Arms
22
Actual Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of combustible cigarettes to the myblu e-cigarette, for up to 56 days. This study is designed as an open-label, partially-randomized, parallel-arm, multi-site study in healthy adult smokers.

Some subjects will be selected to take part in additional procedures as part of a pharmacokinetics (PK) sub-study.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Continue-smoking
  • Other: myblu Tobacco 2.5%
  • Other: myblu Tobacco 4.0%
  • Other: myblu Honeymoon 2.5%
  • Other: myblu Honeymoon 4.0%
  • Other: JUUL 5%
N/A

Detailed Description

Subjects are randomized to either continue smoking conventional cigarettes, or switch to use the myblu e-cigarette. Within the "myblu" arm, subjects were assigned to one of four variants of the myblu e-cigarette, having different flavors and nicotine strengths. Initial product assignment for each subject was based on preference as a method to enhance compliance. To further improve compliance through Day 56, subjects may have been allowed to choose to switch to another variant of the myblu e-cigarette, or to continue using the same e-liquid selected initially.

Study Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An Open-label, Parallel Study to Assess Tobacco-related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-day Switch to Myblu E-cigarettes in Adult Smokers
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Continue-smoking

The subject's usual brand of combustible cigarette

Other: Continue-smoking
Ad-libitum use of subjects' usual brand combustible cigarette

Experimental: myblu Tobacco 2.5%

myblu e-cigarette system with Tobacco flavor, 2.5% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.

Other: myblu Tobacco 2.5%
Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine

Experimental: myblu Tobacco 4.0%

myblu e-cigarette system with Tobacco flavor, 4.0% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.

Other: myblu Tobacco 4.0%
Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine

Experimental: myblu Honeymoon 2.5%

myblu e-cigarette system with Honeymoon flavor, 2.5% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.

Other: myblu Honeymoon 2.5%
Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine

Experimental: myblu Honeymoon 4.0%

myblu e-cigarette system with Honeymoon flavor, 4.0% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.

Other: myblu Honeymoon 4.0%
Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine

Active Comparator: JUUL 5%

JUUL® system with Virginia Tobacco Flavor JUULpod, 5.0% nicotine. This arm is only included in the PK sub-study.

Other: JUUL 5%
Ad-libitum use of JUUL 5% e-cigarette

Outcome Measures

Primary Outcome Measures

  1. Concentration of Carboxyhemoglobin in Blood [Baseline and 56 days]

    Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood

  2. Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours [Baseline and 56 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) excreted in urine in 24-hours

  3. Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours [Baseline and 56 days]

    Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA - a biomarker of exposure to acrolein) excreted in urine in 24-hours

  4. Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours [Baseline and 56 days]

    Change from baseline in the amount of s-phenyl mercapturic acid (S-PMA - a biomarker of exposure to benzene) excreted in urine in 24-hours

Secondary Outcome Measures

  1. Amount of Nicotine Equivalents in Urine in 24 Hours [Baseline and 56 days]

    The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours

  2. Level of White Blood Cells [Baseline and 56 days]

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

  3. Subjective Measure: Nicotine Withdrawal Symptoms Total Score [56 days]

    Nicotine withdrawal symptoms are measured using the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) questionnaire. The DSM-5 and craving items from the MTWS-R have been included. The subjects rate themselves on the questionnaire, which includes symptoms such as angry, irritable, frustrated, depressed mood, restless, insomnia. Each question is rated from 0 (none) to 4 (severe). Total scores may range from 0 to a maximum of 32.

  4. Maximum Nicotine Concentration in Blood [5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose]

    The maximum nicotine concentration in blood (Cmax)

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Having smoked ≥5 manufactured combustible cigarettes per day for at least one year

  • Exhaled carbon monoxide level of >10 ppm at screening

  • Tested positive for urinary cotinine (approximately 200 ng/mL) at screening

Exclusion Criteria:
  • Relevant illness history

  • Relevant medication use

  • Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2

  • Allergy to propylene glycol or glycerin

  • Use of nicotine-containing products other than manufactured cigarettes

  • Use of prescription smoking cessation treatments

  • Smokers who draw smoke into their mouth and throat but do not inhale

  • Intent or desire to stop smoking

  • Female subjects who are pregnant, lactating, or intend to become pregnant

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1CelerionLincolnNebraskaUnited States68502

Sponsors and Collaborators

  • Fontem Ventures BV

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Fontem Ventures BV
ClinicalTrials.gov Identifier:
NCT04019626
Other Study ID Numbers:
  • CA22747
First Posted:
Jul 15, 2019
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleMyblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smokingJUUL 5%
Arm/Group DescriptionUse of myblu e-cigarette system with tobacco flavor 2.5% nicotineUse of myblu e-cigarette system with tobacco flavor 4.0% nicotineUse of myblu e-cigarette system with Honeymoon flavor 2.5% nicotineUse of myblu e-cigarette system with Honeymoon flavor 4.0% nicotineThe subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigaretteUse of JUUL 5% nicotine e-cigarette
Period Title: Overall Study
STARTED424245464421
COMPLETED363237393820
NOT COMPLETED6108761

Baseline Characteristics

Arm/Group TitleMyblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smokingTotal
Arm/Group DescriptionUse of myblu e-cigarette system with tobacco flavor 2.5% nicotineUse of myblu e-cigarette system with tobacco flavor 4.0% nicotineUse of myblu e-cigarette system with Honeymoon flavor 2.5% nicotineUse of myblu e-cigarette system with Honeymoon flavor 4.0% nicotineThe subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigaretteTotal of all reporting groups
Overall Participants4242454644219
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
39.9
(11.72)
37.8
(10.47)
40.3
(9.43)
40.3
(9.75)
39.7
(10.44)
39.6
(10.32)
Sex: Female, Male (Count of Participants)
Female
14
33.3%
14
33.3%
18
40%
20
43.5%
18
40.9%
84
38.4%
Male
28
66.7%
28
66.7%
27
60%
26
56.5%
26
59.1%
135
61.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
1
2.2%
0
0%
1
0.5%
Asian
1
2.4%
1
2.4%
0
0%
0
0%
0
0%
2
0.9%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
1
2.2%
0
0%
1
0.5%
Black or African American
12
28.6%
16
38.1%
18
40%
16
34.8%
13
29.5%
75
34.2%
White
27
64.3%
23
54.8%
24
53.3%
27
58.7%
30
68.2%
131
59.8%
More than one race
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
2
4.8%
2
4.8%
3
6.7%
1
2.2%
1
2.3%
9
4.1%
Body mass index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]
28.0
(4.7)
30.0
(4.9)
28.9
(4.7)
28.9
(5.2)
29.9
(5.6)
29.1
(5.1)
Blood carboxyhemoglobin (COHb) % (% saturation) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [% saturation]
4.9
(2.2)
4.8
(1.8)
4.8
(2.1)
5.3
(1.9)
5.7
(2.0)
5.1
(2.0)
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted in urine (ng/24 hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/24 hours]
411.0
(333.2)
406.8
(328.8)
410.4
(351.2)
479.4
(404.2)
513.7
(403.7)
444.26
(346.2)
3-hydroxypropylmercapturic acid (3-HPMA) amount excreted in urine (ug/24 hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ug/24 hours]
1592.5
(818.2)
1730.3
(1044.2)
1749.7
(780.1)
1919.0
(999.8)
2214.0
(1172.6)
1841.1
(963.0)
S-phenyl mercapturic acid (S-PMA) amount excreted in urine (ug/24 hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ug/24 hours]
5.3
(3.7)
5.9
(4.3)
6.5
(5.1)
7.2
(5.2)
8.6
(5.9)
6.7
(4.8)
Nicotine equivalents amount excreted in urine (mg/24 hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/24 hours]
13.6
(6.8)
14.1
(7.5)
17.1
(13.3)
16.2
(6.5)
18.0
(7.3)
15.8
(8.3)
Level of white blood cells (cells*thousands/uL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells*thousands/uL]
7.7
(2.0)
7.0
(2.0)
6.8
(1.8)
7.4
(2.0)
7.2
(2.2)
7.2
(2.0)

Outcome Measures

1. Primary Outcome
TitleConcentration of Carboxyhemoglobin in Blood
DescriptionChange from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood
Time FrameBaseline and 56 days

Outcome Measure Data

Analysis Population Description
Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (cf "Study Description"). Therefore, the number of subjects analysed in one arm may be different from the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Arm/Group TitleMyblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smoking
Arm/Group DescriptionUse of myblu e-cigarette system with tobacco flavor 2.5% nicotineUse of myblu e-cigarette system with tobacco flavor 4.0% nicotineUse of myblu e-cigarette system with Honeymoon flavor 2.5% nicotineUse of myblu e-cigarette system with Honeymoon flavor 4.0% nicotineThe subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
Measure Participants3249243337
Mean (Standard Deviation) [% change from baseline]
-59.6
(23.3)
-62.7
(19.4)
-46.4
(35.1)
-62.7
(21.2)
8.5
(28.3)
2. Primary Outcome
TitleAmount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
DescriptionChange 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) excreted in urine in 24-hours
Time FrameBaseline and 56 days

Outcome Measure Data

Analysis Population Description
Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Arm/Group TitleMyblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smoking
Arm/Group DescriptionUse of myblu e-cigarette system with tobacco flavor 2.5% nicotineUse of myblu e-cigarette system with tobacco flavor 4.0% nicotineUse of myblu e-cigarette system with Honeymoon flavor 2.5% nicotineUse of myblu e-cigarette system with Honeymoon flavor 4.0% nicotineThe subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
Measure Participants3252253538
Mean (Standard Deviation) [% change from baseline]
-58.3
(72.8)
-44.7
(150.5)
-62.7
(36.2)
-70.7
(33.7)
1.1
(29.6)
3. Primary Outcome
TitleAmount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
DescriptionChange from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA - a biomarker of exposure to acrolein) excreted in urine in 24-hours
Time FrameBaseline and 56 days

Outcome Measure Data

Analysis Population Description
Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Arm/Group TitleMyblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smoking
Arm/Group DescriptionUse of myblu e-cigarette system with tobacco flavor 2.5% nicotineUse of myblu e-cigarette system with tobacco flavor 4.0% nicotineUse of myblu e-cigarette system with Honeymoon flavor 2.5% nicotineUse of myblu e-cigarette system with Honeymoon flavor 4.0% nicotineThe subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
Measure Participants3252253538
Mean (Standard Deviation) [% change from baseline]
-60.0
(28.2)
-55.7
(46.1)
-50.5
(36.2)
-53.8
(64.5)
1.6
(40.6)
4. Primary Outcome
TitleAmount of S-phenyl Mercapturic Acid in Urine in 24 Hours
DescriptionChange from baseline in the amount of s-phenyl mercapturic acid (S-PMA - a biomarker of exposure to benzene) excreted in urine in 24-hours
Time FrameBaseline and 56 days

Outcome Measure Data

Analysis Population Description
Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Arm/Group TitleMyblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smoking
Arm/Group DescriptionUse of myblu e-cigarette system with tobacco flavor 2.5% nicotineUse of myblu e-cigarette system with tobacco flavor 4.0% nicotineUse of myblu e-cigarette system with Honeymoon flavor 2.5% nicotineUse of myblu e-cigarette system with Honeymoon flavor 4.0% nicotineThe subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
Measure Participants3252253538
Mean (Standard Deviation) [% change from baseline]
-85.9
(32.5)
-44.9
(257.5)
-63.1
(79.3)
-73.8
(55.7)
-2.7
(38.4)
5. Secondary Outcome
TitleAmount of Nicotine Equivalents in Urine in 24 Hours
DescriptionThe change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours
Time FrameBaseline and 56 days

Outcome Measure Data

Analysis Population Description
Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Arm/Group TitleMyblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smoking
Arm/Group DescriptionUse of myblu e-cigarette system with tobacco flavor 2.5% nicotineUse of myblu e-cigarette system with tobacco flavor 4.0% nicotineUse of myblu e-cigarette system with Honeymoon flavor 2.5% nicotineUse of myblu e-cigarette system with Honeymoon flavor 4.0% nicotineThe subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
Measure Participants3251243538
Mean (Standard Deviation) [% change from baseline]
-7.8
(74.0)
16.6
(61.1)
-13.8
(54.5)
-1.3
(38.8)
-7.0
(27.0)
6. Secondary Outcome
TitleLevel of White Blood Cells
DescriptionThe change from baseline in the level of white blood cells, which is a biomarker of potential harm
Time FrameBaseline and 56 days

Outcome Measure Data

Analysis Population Description
Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Arm/Group TitleMyblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smoking
Arm/Group DescriptionUse of myblu e-cigarette system with tobacco flavor 2.5% nicotineUse of myblu e-cigarette system with tobacco flavor 4.0% nicotineUse of myblu e-cigarette system with Honeymoon flavor 2.5% nicotineUse of myblu e-cigarette system with Honeymoon flavor 4.0% nicotineThe subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
Measure Participants3151253537
Mean (Standard Deviation) [% change from baseline]
-9.2
(16.7)
-4.3
(16.8)
-8.7
(17.9)
-8.5
(16.3)
4.7
(17.0)
7. Secondary Outcome
TitleSubjective Measure: Nicotine Withdrawal Symptoms Total Score
DescriptionNicotine withdrawal symptoms are measured using the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) questionnaire. The DSM-5 and craving items from the MTWS-R have been included. The subjects rate themselves on the questionnaire, which includes symptoms such as angry, irritable, frustrated, depressed mood, restless, insomnia. Each question is rated from 0 (none) to 4 (severe). Total scores may range from 0 to a maximum of 32.
Time Frame56 days

Outcome Measure Data

Analysis Population Description
Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study
Arm/Group TitleMyblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smoking
Arm/Group DescriptionUse of myblu e-cigarette system with tobacco flavor 2.5% nicotineUse of myblu e-cigarette system with tobacco flavor 4.0% nicotineUse of myblu e-cigarette system with Honeymoon flavor 2.5% nicotineUse of myblu e-cigarette system with Honeymoon flavor 4.0% nicotineThe subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette
Measure Participants3151263338
Mean (Standard Deviation) [score on a scale]
8.6
(6.7)
5.7
(5.5)
7.1
(5.3)
6.8
(5.8)
8.1
(5.9)
8. Secondary Outcome
TitleMaximum Nicotine Concentration in Blood
DescriptionThe maximum nicotine concentration in blood (Cmax)
Time Frame5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose

Outcome Measure Data

Analysis Population Description
Sub-group of participants who participated in the PK sub-study, on Day 1
Arm/Group TitleMyblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smokingJUUL® 5.0%
Arm/Group DescriptionUse of myblu e-cigarette system with tobacco flavor 2.5% nicotineUse of myblu e-cigarette system with tobacco flavor 4.0% nicotineUse of myblu e-cigarette system with Honeymoon flavor 2.5% nicotineUse of myblu e-cigarette system with Honeymoon flavor 4.0% nicotineThe subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigaretteUse of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
Measure Participants201919222419
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]
4.0
(196.3)
7.3
(118.6)
4.3
(191.3)
8.9
(159.8)
13.5
(62.5)
6.9
(160.1)

Adverse Events

Time Frame72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
Adverse Event Reporting Description Adverse events of the Safety Population (all subjects with at least one reported product use from Day -1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects at risk in one arm may be different than the number of subjects who were initially assigned to this product at the study start.
Arm/Group TitleMyblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smokingJUUL® 5.0%
Arm/Group DescriptionUse of myblu e-cigarette system with tobacco flavor 2.5% nicotineUse of myblu e-cigarette system with tobacco flavor 4.0% nicotineUse of myblu e-cigarette system with Honeymoon flavor 2.5% nicotineUse of myblu e-cigarette system with Honeymoon flavor 4.0% nicotineThe subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigaretteUse of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine
All Cause Mortality
Myblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smokingJUUL® 5.0%
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/55 (0%) 0/71 (0%) 0/47 (0%) 0/57 (0%) 0/44 (0%) 0/21 (0%)
Serious Adverse Events
Myblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smokingJUUL® 5.0%
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/55 (0%) 0/71 (0%) 0/47 (0%) 0/57 (0%) 0/44 (0%) 0/21 (0%)
Other (Not Including Serious) Adverse Events
Myblu Tobacco Flavor 2.5%Myblu Tobacco Flavor 4.0%Myblu Honeymoon 2.5%Myblu Honeymoon 4.0%Continue-smokingJUUL® 5.0%
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total8/55 (14.5%) 10/71 (14.1%) 6/47 (12.8%) 6/57 (10.5%) 7/44 (15.9%) 8/21 (38.1%)
Gastrointestinal disorders
Diarrhoea3/55 (5.5%) 1/71 (1.4%) 0/47 (0%) 00/57 (0%) 00/44 (0%) 00/21 (0%) 0
Dyspepsia1/55 (1.8%) 0/71 (0%) 0/47 (0%) 0/57 (0%) 2/44 (4.5%) 0/21 (0%)
Nausea1/55 (1.8%) 1/71 (1.4%) 0/47 (0%) 0/57 (0%) 0/44 (0%) 1/21 (4.8%)
Infections and infestations
Upper respiratory tract infection0/55 (0%) 0/71 (0%) 2/47 (4.3%) 2/57 (3.5%) 0/44 (0%) 4/21 (19%)
Urinary tract infection0/55 (0%) 0/71 (0%) 0/47 (0%) 0/57 (0%) 0/44 (0%) 1/21 (4.8%)
Injury, poisoning and procedural complications
Laceration0/55 (0%) 2/71 (2.8%) 0/47 (0%) 0/57 (0%) 1/44 (2.3%) 0/21 (0%)
Musculoskeletal and connective tissue disorders
Back pain0/55 (0%) 0/71 (0%) 0/47 (0%) 2/57 (3.5%) 0/44 (0%) 0/21 (0%)
Nervous system disorders
Dizziness0/55 (0%) 3/71 (4.2%) 0/47 (0%) 0/57 (0%) 0/44 (0%) 0/21 (0%)
Headache0/55 (0%) 1/71 (1.4%) 4/47 (8.5%) 2/57 (3.5%) 4/44 (9.1%) 0/21 (0%)
Respiratory, thoracic and mediastinal disorders
Cough3/55 (5.5%) 2/71 (2.8%) 0/47 (0%) 0/57 (0%) 0/44 (0%) 1/21 (4.8%)
Hiccups0/55 (0%) 0/71 (0%) 0/47 (0%) 0/57 (0%) 0/44 (0%) 1/21 (4.8%)

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.

Results Point of Contact

Name/TitlePaul Morris
OrganizationNerudia Ltd
Phone+44 7508 708 917
Emailpaul.morris@nerudia.com
Responsible Party:
Fontem Ventures BV
ClinicalTrials.gov Identifier:
NCT04019626
Other Study ID Numbers:
  • CA22747
First Posted:
Jul 15, 2019
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021