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A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes
NA trial testing Continue-smoking in Healthy Volunteers in 240 participants. Completed in 31 December 2020.
| Lead sponsor | Fontem Ventures BV |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 240 |
| Start date | 1 March 2019 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across United States |
Fontem Ventures BV
Adults 21 to 65, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood
| Group | Value | 95% CI |
|---|---|---|
| Myblu Tobacco Flavor 2.5% | -59.6 | ± 23.3 |
| Myblu Tobacco Flavor 4.0% | -62.7 | ± 19.4 |
| Myblu Honeymoon 2.5% | -46.4 | ± 35.1 |
| Myblu Honeymoon 4.0% | -62.7 | ± 21.2 |
| Continue-smoking | 8.5 | ± 28.3 |
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
| Group | Value | 95% CI |
|---|---|---|
| Myblu Tobacco Flavor 2.5% | -58.3 | ± 72.8 |
| Myblu Tobacco Flavor 4.0% | -44.7 | ± 150.5 |
| Myblu Honeymoon 2.5% | -62.7 | ± 36.2 |
| Myblu Honeymoon 4.0% | -70.7 | ± 33.7 |
| Continue-smoking | 1.1 | ± 29.6 |
Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA - a biomarker of exposure to acrolein) excreted in urine in 24-hours
| Group | Value | 95% CI |
|---|---|---|
| Myblu Tobacco Flavor 2.5% | -60.0 | ± 28.2 |
| Myblu Tobacco Flavor 4.0% | -55.7 | ± 46.1 |
| Myblu Honeymoon 2.5% | -50.5 | ± 36.2 |
| Myblu Honeymoon 4.0% | -53.8 | ± 64.5 |
| Continue-smoking | 1.6 | ± 40.6 |
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
| Group | Value | 95% CI |
|---|---|---|
| Myblu Tobacco Flavor 2.5% | -85.9 | ± 32.5 |
| Myblu Tobacco Flavor 4.0% | -44.9 | ± 257.5 |
| Myblu Honeymoon 2.5% | -63.1 | ± 79.3 |
| Myblu Honeymoon 4.0% | -73.8 | ± 55.7 |
| Continue-smoking | -2.7 | ± 38.4 |
The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours
| Group | Value | 95% CI |
|---|---|---|
| Myblu Tobacco Flavor 2.5% | -7.8 | ± 74.0 |
| Myblu Tobacco Flavor 4.0% | 16.6 | ± 61.1 |
| Myblu Honeymoon 2.5% | -13.8 | ± 54.5 |
| Myblu Honeymoon 4.0% | -1.3 | ± 38.8 |
| Continue-smoking | -7.0 | ± 27.0 |
The change from baseline in the level of white blood cells, which is a biomarker of potential harm
| Group | Value | 95% CI |
|---|---|---|
| Myblu Tobacco Flavor 2.5% | -9.2 | ± 16.7 |
| Myblu Tobacco Flavor 4.0% | -4.3 | ± 16.8 |
| Myblu Honeymoon 2.5% | -8.7 | ± 17.9 |
| Myblu Honeymoon 4.0% | -8.5 | ± 16.3 |
| Continue-smoking | 4.7 | ± 17.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Myblu Tobacco Flavor 2.5% | 8.6 | ± 6.7 |
| Myblu Tobacco Flavor 4.0% | 5.7 | ± 5.5 |
| Myblu Honeymoon 2.5% | 7.1 | ± 5.3 |
| Myblu Honeymoon 4.0% | 6.8 | ± 5.8 |
| Continue-smoking | 8.1 | ± 5.9 |
The maximum nicotine concentration in blood (Cmax)
| Group | Value | 95% CI |
|---|---|---|
| Myblu Tobacco Flavor 2.5% | 4.0 | ± 196.3 |
| Myblu Tobacco Flavor 4.0% | 7.3 | ± 118.6 |
| Myblu Honeymoon 2.5% | 4.3 | ± 191.3 |
| Myblu Honeymoon 4.0% | 8.9 | ± 159.8 |
| Continue-smoking | 13.5 | ± 62.5 |
| JUUL® 5.0% | 6.9 | ± 160.1 |
Time frame: 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Myblu Tobacco Flavor 2.5% | Myblu Tobacco Flavor 4.0% | Myblu Honeymoon 2.5% | Myblu Honeymoon 4.0% | Continue-smoking | JUUL® 5.0% |
|---|---|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — | — | — |
| Laceration | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — | — |
| Hiccups | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
Data from ClinicalTrials.gov NCT04019626 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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