Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continue-smoking | Active Comparator | The subject's usual brand of combustible cigarette |
|
| myblu Tobacco 2.5% | Experimental | 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. |
|
| myblu Tobacco 4.0% | Experimental | 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. |
|
| myblu Honeymoon 2.5% | Experimental | 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. |
|
| myblu Honeymoon 4.0% | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continue-smoking | Other | Ad-libitum use of subjects' usual brand combustible cigarette |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Carboxyhemoglobin in Blood | Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood | Baseline and 56 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) excreted in urine in 24-hours | Baseline and 56 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 in 24-hours | Baseline and 56 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 in 24-hours | Baseline and 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Nicotine Equivalents in Urine in 24 Hours | The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours | Baseline and 56 days |
| Level of White Blood Cells |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Myblu Tobacco Flavor 2.5% | Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine |
| FG001 | Myblu Tobacco Flavor 4.0% | Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine |
| FG002 | Myblu Honeymoon 2.5% | Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine |
| FG003 | Myblu Honeymoon 4.0% | Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine |
| FG004 | Continue-smoking | The subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette |
| FG005 | JUUL 5% | Use of JUUL 5% nicotine e-cigarette |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat (ITT) population: randomized subjects in the main study with at least one documented product-use experience from Day 1. The JUUL5% arm is not included as it was used only for the PK sub-study as a secondary objective, and not the main study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Myblu Tobacco Flavor 2.5% | Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine |
| BG001 | Myblu Tobacco Flavor 4.0% | Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentration of Carboxyhemoglobin in Blood | Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood | 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 | Posted | Mean | Standard Deviation | % change from baseline | Baseline and 56 days |
|
72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Myblu Tobacco Flavor 2.5% | Use of myblu e-cigarette system with tobacco flavor 2.5% nicotine |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Morris | Nerudia Ltd | +44 7508 708 917 | paul.morris@nerudia.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2020 | Apr 14, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2020 | Apr 14, 2021 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| JUUL 5% | Active Comparator | JUUL® system with Virginia Tobacco Flavor JUULpod, 5.0% nicotine. This arm is only included in the PK sub-study. |
|
| myblu Tobacco 2.5% |
| Other |
Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine |
|
| myblu Tobacco 4.0% | Other | Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine |
|
| myblu Honeymoon 2.5% | Other | Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine |
|
| myblu Honeymoon 4.0% | Other | Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine |
|
| JUUL 5% | Other | Ad-libitum use of JUUL 5% e-cigarette |
|
The change from baseline in the level of white blood cells, which is a biomarker of potential harm
| Baseline and 56 days |
| Subjective Measure: Nicotine Withdrawal Symptoms Total Score | 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. | 56 days |
| Maximum Nicotine Concentration in Blood | The maximum nicotine concentration in blood (Cmax) | 5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose |
| BG002 | Myblu Honeymoon 2.5% | Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine |
| BG003 | Myblu Honeymoon 4.0% | Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine |
| BG004 | Continue-smoking | The subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Blood carboxyhemoglobin (COHb) % | Mean | Standard Deviation | % saturation |
|
| 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) amount excreted in urine | Some samples were missing | Mean | Standard Deviation | ng/24 hours |
|
| 3-hydroxypropylmercapturic acid (3-HPMA) amount excreted in urine | Some samples were missing | Mean | Standard Deviation | ug/24 hours |
|
| S-phenyl mercapturic acid (S-PMA) amount excreted in urine | Some samples were missing | Mean | Standard Deviation | ug/24 hours |
|
| Nicotine equivalents amount excreted in urine | Some samples were missing | Mean | Standard Deviation | mg/24 hours |
|
| Level of white blood cells | Some samples were missing | Mean | Standard Deviation | cells*thousands/uL |
|
| OG001 |
| Myblu Tobacco Flavor 4.0% |
Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine |
| OG002 | Myblu Honeymoon 2.5% | Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine |
| OG003 | Myblu Honeymoon 4.0% | Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine |
| OG004 | Continue-smoking | The subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette |
|
|
| Primary | 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) excreted in urine in 24-hours | 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 | Posted | Mean | Standard Deviation | % change from baseline | Baseline and 56 days |
|
|
|
| Primary | 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 in 24-hours | 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 | Posted | Mean | Standard Deviation | % change from baseline | Baseline and 56 days |
|
|
|
| Primary | 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 in 24-hours | 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 | Posted | Mean | Standard Deviation | % change from baseline | Baseline and 56 days |
|
|
|
| Secondary | Amount of Nicotine Equivalents in Urine in 24 Hours | The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours | 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 | Posted | Mean | Standard Deviation | % change from baseline | Baseline and 56 days |
|
|
|
| Secondary | Level of White Blood Cells | The change from baseline in the level of white blood cells, which is a biomarker of potential harm | 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 | Posted | Mean | Standard Deviation | % change from baseline | Baseline and 56 days |
|
|
|
| Secondary | Subjective Measure: Nicotine Withdrawal Symptoms Total Score | 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. | 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 | Posted | Mean | Standard Deviation | score on a scale | 56 days |
|
|
|
| Secondary | Maximum Nicotine Concentration in Blood | The maximum nicotine concentration in blood (Cmax) | Sub-group of participants who participated in the PK sub-study, on Day 1 | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 8 |
| 55 |
| EG001 | Myblu Tobacco Flavor 4.0% | Use of myblu e-cigarette system with tobacco flavor 4.0% nicotine | 0 | 71 | 0 | 71 | 10 | 71 |
| EG002 | Myblu Honeymoon 2.5% | Use of myblu e-cigarette system with Honeymoon flavor 2.5% nicotine | 0 | 47 | 0 | 47 | 6 | 47 |
| EG003 | Myblu Honeymoon 4.0% | Use of myblu e-cigarette system with Honeymoon flavor 4.0% nicotine | 0 | 57 | 0 | 57 | 6 | 57 |
| EG004 | Continue-smoking | The subject's usual brand of combustible cigarette Continue-smoking: Ad-libitum use of subjects' usual brand combustible cigarette | 0 | 44 | 0 | 44 | 7 | 44 |
| EG005 | JUUL® 5.0% | Use of JUUL® system with Virginia Tobacco Flavor JUULPod, 5.0% nicotine | 0 | 21 | 0 | 21 | 8 | 21 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|