A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes

NCT04430634 | Completed Results

• 1 other identifier: CA22749
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (4)

• Level of White Blood Cells

  Baseline and 8 days

• Spirometry: Forced Expiratory Volume in 1 Second

  Baseline and 8 days

• Spirometry: Forced Vital Capacity

  Baseline and 8 days

• Subjective Measure: Urge to Smoke

  8 days

Study Arms (8)

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).

Other: Myblu variant A; Other: Myblu variant B; Other: Myblu variant C; Other: Myblu variant D

BCAD

EXPERIMENTAL

Same as previous arm, but in a different randomization order.

Other: Myblu variant A; Other: Myblu variant B; Other: Myblu variant C; Other: Myblu variant D

CDBA

EXPERIMENTAL

Same as previous arm, but in a different randomization order.

Other: Myblu variant A; Other: Myblu variant B; Other: Myblu variant C; Other: Myblu variant D

DACB

EXPERIMENTAL

Same as previous arm, but in a different randomization order.

Other: Myblu variant A; Other: Myblu variant B; Other: Myblu variant C; Other: Myblu variant D

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).

Other: Myblu variant E; Other: Myblu variant F; Other: Myblu variant G; Other: Myblu variant H

FGEH

EXPERIMENTAL

Same as previous arm, but in a different randomization order.

Other: Myblu variant E; Other: Myblu variant F; Other: Myblu variant G; Other: Myblu variant H

GHFE

EXPERIMENTAL

Same as previous arm, but in a different randomization order.

Other: Myblu variant E; Other: Myblu variant F; Other: Myblu variant G; Other: Myblu variant H

HEGF

EXPERIMENTAL

Same as previous arm, but in a different randomization order.

Other: Myblu variant E; Other: Myblu variant F; Other: Myblu variant G; Other: Myblu variant H

Interventions

Myblu variant A OTHER

Use of Myblu e-cigarette with flavor A 2.4% nicotine

ABDC; BCAD; CDBA; DACB

Myblu variant B OTHER

Use of Myblu e-cigarette with flavor B 3.6% nicotine

ABDC; BCAD; CDBA; DACB

Myblu variant C OTHER

Use of Myblu e-cigarette with flavor C 2.5% nicotine

ABDC; BCAD; CDBA; DACB

Myblu variant D OTHER

Use of Myblu e-cigarette with flavor D 4.0% nicotine

ABDC; BCAD; CDBA; DACB

Myblu variant E OTHER

Use of Myblu e-cigarette with flavor E 3.6% nicotine

EFHG; FGEH; GHFE; HEGF

Myblu variant F OTHER

Use of Myblu e-cigarette with flavor F 2.4% nicotine

EFHG; FGEH; GHFE; HEGF

Myblu variant G OTHER

Use of Myblu e-cigarette with flavor G 4.0% nicotine

EFHG; FGEH; GHFE; HEGF

Myblu variant H OTHER

Use of Myblu e-cigarette with flavor H 3.6% nicotine

EFHG; FGEH; GHFE; HEGF

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fontem US LLC: lead
• Fontem Ventures BV: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Related Publications (1)

• 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.

  PMID: 34435305 DERIVED

Results Point of Contact

• Title: Paul Morris
• Organization: Nerudia

paul.morris@nerudia.com

+44 7508 708 917

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: November 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: June 7, 2021
• Results First Posted: June 7, 2021

Record last verified: 2021-05

Locations

US (1)