Clinical trial NCT04430634: A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes
Official title: An Open-Label, Randomized, Crossover Study to Assess Nicotine Uptake, Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Puff Topography With Use of mybluTM Electronic Cigarettes in Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Fontem Ventures BV
Sponsor class: INDUSTRY
Collaborators: name: Fontem Ventures BV
First posted: 2020-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* smoking an average of at least 10 manufactured combustible cigarettes per day for at least 12 months prior to Screening
* tested positive for urine cotinine (≥ 200 ng/mL) at Screening
* exhaled carbon monoxide \> 10 ppm (parts per million) at Screening

Exclusion Criteria:

* relevant illness history
* relevant medication use
* body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening
* allergy to propylene glycol or glycerin
* use of nicotine-containing products other than manufactured combustible cigarettes within 14 days prior to Check-in
* use of any prescription smoking cessation treatments within 3 months prior to Check-in
* smokers who draw smoke from the cigarette into the mouth and throat but do not inhale
* planning to quit smoking during the study
* female subjects who are pregnant, lactating, or intend to become pregnant

Primary outcomes:
measure: Maximum Nicotine Concentration in Blood
timeFrame: 180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)
measure: Concentration of Carboxyhemoglobin in Blood
timeFrame: Baseline and 8 days
measure: Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
timeFrame: Baseline and 8 days
measure: Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
timeFrame: Baseline and 8 days
measure: Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
timeFrame: Baseline and 8 days
Secondary outcomes:
measure: Level of White Blood Cells
timeFrame: Baseline and 8 days
measure: Spirometry: Forced Expiratory Volume in 1 Second
timeFrame: Baseline and 8 days
measure: Spirometry: Forced Vital Capacity
timeFrame: Baseline and 8 days
measure: Subjective Measure: Urge to Smoke
timeFrame: 8 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
References:
citation: 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.