A BA study to investigate nicotine delivery in healthy volunteers
Research type
Research Study
Full title
A randomised open-label, 3-way crossover, relative bioavailability study of nicotine delivered by an electronic inhaler, Nicorette® Inhalator and Nicorette® QuickMist.
IRAS ID
1005952
Contact name
Gabrielle Brill
Contact email
Sponsor organisation
Ventus Medical Limited
Eudract number
2022-001982-10
ISRCTN Number
ISRCTN17715270
Clinicaltrials.gov Identifier
N/A
Research summary
Summary of Research
The purpose of this study is to investigate nicotine administered in the form of three different nicotine replacement therapies (NRTs); a test product (ENHALE Inhaler with cartridge) vs Nicorette® Inhalator & Nicorette® QuickMist.The study will enrol 24 healthy male smokers and the main objectives of this study are:
- To determine the maximum concentration of nicotine in the blood following the use of three different NRTs for a period of four hours each and to evaluate whether there are differences in the maximum concentration of nicotine in the blood.- To investigate the concentration of nicotine in the blood, how this changes over a period of time and to evaluate whether there are differences in the concentration in the blood between the three different NRTs.
- To evaluate and compare the bioavailability (the degree and rate at which a substance (such as a drug) is absorbed into the body or is made available at the site of its’ desired effect) of nicotine administered via a test product and two commercially available NRTs.
- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of nicotine when it is administered as single doses via three different NRTs.
- To determine the effect of nicotine on the body by measuring the relief from nicotine cravings following the use of the three different NRTs.
Participants will be required to use each of the products; one product per study day and during each study day, participants will be given the products to use once per hour for four hours (total of 5 administrations per day). Blood samples will be taken (specifically after the first and final hourly use) in order to measure the concentration of nicotine in the blood. The results will then be compared to determine if there are any significant differences in the safety profile of nicotine, the concentration of nicotine in the blood and to determine whether there are any differences between the three NRTs.
Summary of Results
"The purpose of this study was to investigate nicotine administered in the form of three different nicotine replacement therapies (NRTs); a test product (ENHALE Electronic Inhaler with nicotine cartridge) and two commercially available NRTs (Nicorette® Inhalator & Nicorette® QuickMist). The main objectives of this study were as follows:
To determine the maximum concentration of nicotine in the blood following use of three different NRTs over a period of four hours each and to evaluate whether there were differences in the maximum concentration of nicotine in the blood between the three different NRTs.
To investigate how the concentration of nicotine in the blood changed over a period of time and to evaluate whether there were differences in the concentration in the blood between the three different NRTs.
To evaluate and compare the bioavailability (the degree and rate at which a substance (such as a drug) is absorbed into the body or is made available at the site of its’ desired effect) of nicotine administered via a test product (ENHALE Electronic Inhaler with nicotine cartridge) and two commercially available NRTs (Nicorette® Inhalator & Nicorette® QuickMist).
To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of nicotine when it was administered via three different NRTs.
To determine the effect of nicotine on the body by measuring the relief from nicotine cravings following the use of the three different NRTs.
In this study, participants were required to use three different types of NRTs; a test product (ENHALE Electronic Inhaler delivering 0.5 milligram (mg) nicotine per cartridge) and two commercially available NRTs (Nicorette® Inhalator (15 mg nicotine per cartridge) & Nicorette® QuickMist (1 mg nicotine per spray)). Participants were required to use each of the products; on each study day participants were given one product to use once per hour for four hours (total of five administrations per study day).
During each study day and each product use, blood samples were taken at set time points in order to measure the concentration of nicotine in the blood. The results have now been analysed and compared to determine if there were any significant differences in the concentration of nicotine in the blood and to determine whether there were any differences between the two commercially available NRTs versus the test NRT (ENHALE Electronic Inhaler with nicotine cartridge).
The purpose of the data generated in this study was to provide further information and guidance to support the study sponsor in the development of the ENHALE Electronic Inhaler (and nicotine cartridge) as a new NRT.
With respect to the safety objectives of the study, the safety profile of the test product (ENHALE Electronic Inhaler with nicotine cartridge) was considered to be comparable with the marketed comparator products (Nicorette® Inhalator (15 mg nicotine per cartridge) & Nicorette® QuickMist (1 mg nicotine per spray)). All of the reported side effects in the study were considered to be mild in severity and resolved within less than 10 hours following reporting. In addition, the majority of effects were considered to not be related to any of the products and resolved without treatment (other than administration of paracetamol where required). Further to this, the reported effects which were considered related are similar to those which have been reported by product users who regularly use this type of NRT.
As it relates to the other objectives of the study, the following outcomes were reported:
With respect to the assessment of bioavailability, it was noted that the values for the concentration of nicotine following the 1st and 5th administrations of the ENHALE Electronic Inhaler were higher than that of the reference product Nicorette Inhalator. However, the reported values were lower when compared with the reference product Nicorette QuickMist.
Nicotine was more rapidly absorbed from the ENHALE Electronic Inhaler vs the Nicorette Inhalator and Nicorette QuickMist which was demonstrated by the fact that the time taken for the concentration of nicotine to reach its’ maximum in the blood was shorter for ENHALE when compared with the other products.
With respect to nicotine cravings, it was noted that nicotine craving scores lowered with each product administration across all three products administered. The reduction in score was greater between the 1st and 5th administrations of the ENHALE Electronic Inhaler when compared to the Nicorette Inhalator and the Nicorette QuickMist. It should, however, be noted that the data are variable, and no formal analysis was conducted to assess this.
In summary, the data gathered during the study was considered sufficient to meet the objectives of the study."REC name
Wales REC 2
REC reference
22/WA/0188
Date of REC Opinion
19 Aug 2022
REC opinion
Further Information Favourable Opinion