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出境医 / 临床实验 / A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes

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

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. 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 sub-study.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Continue-smoking Other: myblu Tobacco Chill 2.5% Other: myblu Tobacco Chill 4.0% Other: myblu Honeymoon 2.5% Other: myblu Honeymoon 4.0% Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 : March 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021
Arms and Interventions
Arm Intervention/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 Chill 2.5%
myblu e-cigarette system with Tobacco Chill flavor Intense Liquidpod, 2.5% nicotine
 Other: myblu Tobacco Chill 2.5%
Ad-libitum use of myblu e-cigarette with Tobacco Chill flavor 2.5% nicotine
Experimental: myblu Tobacco Chill 4.0%
myblu e-cigarette system with Tobacco Chill flavor Intense Liquidpod, 4.0% nicotine
 Other: myblu Tobacco Chill 4.0%
Ad-libitum use of myblu e-cigarette with Tobacco Chill flavor 4.0% nicotine
Experimental: myblu Honeymoon 2.5%
myblu e-cigarette system with Honeymoon flavor Intense Liquidpod, 2.5% nicotine
 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 Intense Liquidpod, 4.0% nicotine
 Other: myblu Honeymoon 4.0%
Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine
Outcome Measures
Primary Outcome Measures :
  1. Concentration of carboxyhemoglobin in blood [ Time Frame: 56 days ]
    Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood

  2. Amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol in urine in 24 hours [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 in urine in 24 hours [ Time Frame: 56 days ]
    The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours

  2. Level of white blood cells [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 180 minutes following the start of product use (11 measurements over the period) ]
    The maximum nicotine concentration in blood (Cmax)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Layout table for location information
United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Fontem Ventures BV
Tracking Information
First Submitted Date  ICMJE July 12, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date September 24, 2020
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Concentration of carboxyhemoglobin in blood [ Time Frame: 56 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: 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
  • Amount of 3-hydroxypropylmercapturic acid in urine in 24 hours [ Time Frame: 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
  • Amount of s-phenyl mercapturic acid in urine in 24 hours [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Biomarker of Exposure to carboxyhemoglobin (COHb) [ Time Frame: 56 days ]
    Change from baseline in the concentration of COHb in whole blood
  • Biomarker of Exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) [ Time Frame: 56 days ]
    Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) excreted in urine in 24-hours
  • Biomarker of Exposure to Acrolein [ Time Frame: 56 days ]
    Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA) excreted in urine in 24-hours
  • Biomarker of Exposure to Benzene [ Time Frame: 56 days ]
    Change from baseline in the amount of s-phenyl mercapturic acid (S-PMA) excreted in urine in 24-hours
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Amount of nicotine in urine in 24 hours [ Time Frame: 56 days ]
    The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours
  • Level of white blood cells [ Time Frame: 56 days ]
    The change from baseline in the level of white blood cells, which is a biomarker of potential harm
  • Subjective Measure: Nicotine Withdrawal Symptoms [ Time Frame: 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.
  • Maximum nicotine concentration in blood [ Time Frame: 180 minutes following the start of product use (11 measurements over the period) ]
    The maximum nicotine concentration in blood (Cmax)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Biomarkers of Exposure to Nicotine [ Time Frame: 56 days ]
    The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours
  • Biomarker of Potential Harm [ Time Frame: 56 days ]
    The change from baseline in the level of white blood cells
  • Subjective Measure: Nicotine Withdrawal Symptoms [ Time Frame: 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.
  • Nicotine pharmacokinetics [ Time Frame: 180 minutes following the start of product use (11 measurements over the period) ]
    The maximum nicotine concentration in blood (Cmax)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes
Official Title  ICMJE 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
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. 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 sub-study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Other: Continue-smoking
    Ad-libitum use of subjects' usual brand combustible cigarette
  • Other: myblu Tobacco Chill 2.5%
    Ad-libitum use of myblu e-cigarette with Tobacco Chill flavor 2.5% nicotine
  • Other: myblu Tobacco Chill 4.0%
    Ad-libitum use of myblu e-cigarette with Tobacco Chill flavor 4.0% nicotine
  • Other: myblu Honeymoon 2.5%
    Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine
  • Other: myblu Honeymoon 4.0%
    Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine
Study Arms  ICMJE
  • Active Comparator: Continue-smoking
    The subject's usual brand of combustible cigarette
    Intervention: Other: Continue-smoking
  • Experimental: myblu Tobacco Chill 2.5%
    myblu e-cigarette system with Tobacco Chill flavor Intense Liquidpod, 2.5% nicotine
    Intervention: Other: myblu Tobacco Chill 2.5%
  • Experimental: myblu Tobacco Chill 4.0%
    myblu e-cigarette system with Tobacco Chill flavor Intense Liquidpod, 4.0% nicotine
    Intervention: Other: myblu Tobacco Chill 4.0%
  • Experimental: myblu Honeymoon 2.5%
    myblu e-cigarette system with Honeymoon flavor Intense Liquidpod, 2.5% nicotine
    Intervention: Other: myblu Honeymoon 2.5%
  • Experimental: myblu Honeymoon 4.0%
    myblu e-cigarette system with Honeymoon flavor Intense Liquidpod, 4.0% nicotine
    Intervention: Other: myblu Honeymoon 4.0%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04019626
Other Study ID Numbers  ICMJE CA22747
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fontem Ventures BV
Study Sponsor  ICMJE Fontem Ventures BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fontem Ventures BV
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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