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| Name | Class |
|---|---|
| Fontem Ventures BV | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| BCAD | Experimental | Same as previous arm, but in a different randomization order. |
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| CDBA | Experimental | Same as previous arm, but in a different randomization order. |
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| DACB | Experimental | Same as previous arm, but in a different randomization order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myblu variant A | Other | Use of Myblu e-cigarette with flavor A 2.4% nicotine |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Nicotine Concentration in Blood | Maximum nicotine concentration in blood (Cmax) | 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. | 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). | 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). | 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). | Baseline and 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Level of White Blood Cells | The change from baseline in the level of white blood cells, a biomarker of potential harm. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34435305 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2019 | Apr 14, 2021 |
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| 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). |
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| FGEH | Experimental | Same as previous arm, but in a different randomization order. |
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| GHFE | Experimental | Same as previous arm, but in a different randomization order. |
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| HEGF | Experimental | Same as previous arm, but in a different randomization order. |
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| Myblu variant B | Other | Use of Myblu e-cigarette with flavor B 3.6% nicotine |
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| Myblu variant C | Other | Use of Myblu e-cigarette with flavor C 2.5% nicotine |
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| Myblu variant D | Other | Use of Myblu e-cigarette with flavor D 4.0% nicotine |
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| Myblu variant E | Other | Use of Myblu e-cigarette with flavor E 3.6% nicotine |
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| Myblu variant F | Other | Use of Myblu e-cigarette with flavor F 2.4% nicotine |
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| Myblu variant G | Other | Use of Myblu e-cigarette with flavor G 4.0% nicotine |
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| Myblu variant H | Other | Use of Myblu e-cigarette with flavor H 3.6% nicotine |
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| 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. | 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. | 8 days |
| FG001 | BCAD | Same as previous but in a different randomization order |
| FG002 | CDBA | Same as previous but in a different randomization order |
| FG003 | DACB | Same as previous but in a different randomization order |
| FG004 | 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). |
| FG005 | FGEH | Same as previous but in a different randomization order |
| FG006 | GHFE | Same as previous but in a different randomization order |
| FG007 | HEGF | Same as previous but in a different randomization order |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | BCAD | Same as previous but in a different randomization order |
| BG002 | CDBA | Same as previous but in a different randomization order |
| BG003 | DACB | Same as previous but in a different randomization order |
| BG004 | 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). |
| BG005 | FGEH | Same as previous but in a different randomization order |
| BG006 | GHFE | Same as previous but in a different randomization order |
| BG007 | HEGF | Same as previous but in a different randomization order |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| BMI | Body mass index | Mean | Standard Deviation | kg/m^2 |
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| 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 | Maximum Nicotine Concentration in Blood | Maximum nicotine concentration in blood (Cmax) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period) |
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| Primary | Concentration of Carboxyhemoglobin in Blood | Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood. | 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. | Posted | Mean | Standard Deviation | % saturation | Baseline and 8 days |
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| 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 (NNK), excreted in urine during 24 hours (creatinine adjusted). | 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. | Posted | Mean | Standard Deviation | ng/g creatinine | Baseline and 8 days |
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| 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 during 24 hours (creatinine adjusted). | 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. | Posted | Mean | Standard Deviation | ug/g creatinine | Baseline and 8 days |
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| 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 during 24 hours (creatinine adjusted). | 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. | Posted | Mean | Standard Deviation | ug/g creatinine | Baseline and 8 days |
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| Secondary | Level of White Blood Cells | The change from baseline in the level of white blood cells, a biomarker of potential harm. | 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. | Posted | Mean | Standard Deviation | cells*10^9/L | Baseline and 8 days |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | L | Baseline and 8 days |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | L | Baseline and 8 days |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 8 days |
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9 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Product Variant A | MyBlu e-cigarette variant A (2.4% nicotine) | 0 | 19 | 0 | 19 | 1 | 19 |
| EG001 | Product Variant B | MyBlu e-cigarette variant B (3.6% nicotine) | 0 | 19 | 0 | 19 | 4 | 19 |
| EG002 | Product Variant C | MyBlu e-cigarette variant C (2.5% nicotine) | 0 | 19 | 0 | 19 | 3 | 19 |
| EG003 | Product Variant D | MyBlu e-cigarette variant D (4.0% nicotine) | 0 | 20 | 0 | 20 | 2 | 20 |
| EG004 | Product Variant E | MyBlu e-cigarette variant E (3.6% nicotine) | 0 | 19 | 0 | 19 | 3 | 19 |
| EG005 | Product Variant F | MyBlu e-cigarette variant F (2.4% nicotine) | 0 | 19 | 0 | 19 | 2 | 19 |
| EG006 | Product Variant G | MyBlu e-cigarette variant G (4.0% nicotine) | 0 | 20 | 0 | 20 | 0 | 20 |
| EG007 | Product Variant H | MyBlu e-cigarette variant H (3.6% nicotine) | 0 | 20 | 0 | 20 | 3 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Abnormal sensation in eye | Eye disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Eyelid irritation | Eye disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Eyelid pain | Eye disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Swelling of eyelid | Eye disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA® Version 22.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Morris | Nerudia | +44 7508 708 917 | paul.morris@nerudia.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2020 | Apr 14, 2021 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| OG005 | Product Variant F | MyBlu e-cigarette variant F (2.4% nicotine) |
| OG006 | Product Variant G | MyBlu e-cigarette variant G (4.0% nicotine) |
| OG007 | Product Variant H | MyBlu e-cigarette variant H (3.6% nicotine) |
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