Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05260827 |
| Other study ID # |
Karolinska Institutet 2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
February 1, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Karolinska Institutet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a human randomized controlled cross-over study where we investigate the effects of
heated tobacco products (HTP) on lung function and on assessing volatile organic compounds in
exhaled air.
Description:
The World Health Organization estimates that smoking is one of the leading causes of
premature death worldwide with an estimated 5-8 million lives lost annually due to tobacco
usage.
Heated tobacco products (HTP) is a new form of tobacco products. HTP usually consists of a
pod with tobacco that is mixed with glycerol which is inserted into a heating chamber. HTP is
not combusted but only heated. Previous studies into smoking cessation with regular
cigarettes and electronic cigarettes have suggested a risk for double usage instead of
cessation, augmenting a nicotine addiction. There is a risk that HTP use simply enhances
nicotine usage and smoking addiction.
There is limited data on the health effects of HTP. A majority of the studies available have
reported conflicts of interest to manufacturers of HTP. It has been shown that aerosols from
HTP contain toxic compounds and free radicals just as in regular cigarette smoke, albeit in
lower concentrations (6-8). Furthermore, aerosols from HTP can spread in a room, enabling
passive exposure (9). It has been shown that there is a decrease in harmful biomarkers in
smokers that switch to HTP after 5 days of usage but also of a higher HTP consumption
compared to regular smoking. There are few studies on effects of HTP in humans. We seek to
assess the effects of HTP usage on lung function and the presence of volatile organic
compounds in exhaled air using non invasive methods.
Subjects and criteria:
Twenty five male or female occasional tobacco users (age 18-40, maximum 10 cigarettes per
month or 10 pouches of snus per month) will be included. They have to be healthy, having no
preexisting conditions or take any medications. All subjects will have to complete a normal
health declaration.
Methods:
In randomized cross-over fashion subjects will either inhale vapor (1 puff per minute for 30
minutes, total 30 puffs) from a HTP of the brand IQOS (IQOS 3 Multi, Philip Morris AB) or
perform sham-smoking of HTP.
Baseline coitinine in the blood and volatile organic compounds in exhaled air will be
measured. Subjects will then use HTP as described above. Exhaled air is collected following
exhaling a full breath by the volunteer at normal speed through a disposable mouthpiece
connected to an open 129 ml plastic cylinder with valve and manual piston (Bio-VOC-2 breath
sampler, Markes International). The valve has a low resistance which makes it very easy to
blow air through the cylinder. A filter cassette with gas sampling tubes is then connected to
the cylinder where the last 129 ml of the exhaled air remains. Using the piston, the air is
then emptied onto the pipe via the filter. The gas sampling tube and the filter are marked
with unique markings, which can then be linked to a sample code. The procedure can now be
repeated 1-4 times to collect additional exhaled air. The total sampling time is from 2-7
minutes depending on the number of repetitions. After each exposure, exhaled air is collected
3-4 times for approximately two hours.
The gas sampling tube contains an inert adsorbent material which, when heated (~ 300 ° C) in
a oxygen-free carrier gas, releases the volatile organic substances trapped during sampling.
The substances are then analyzed using gas chromatography connected to a mass spectrometer,
where the intensity of the substances' different mass / charge ratios is collected. After
calibrating the instrument's response to various substances, the concentration in the exhaled
air is calculated. For substances where there is no reference substance, a quantification is
performed against a reference substance with a known response factor and identification is
carried out with criterion requirements for match factor by means of a deconvolution program
(AMDIS) against data in a mass spectrum reference library from NIST. Preliminary own tests
and method comparisons with previous studies indicate that the data material will contain in
the order of 30-100 identified volatile organic compounds.
Specification of VOCs:
The exhaled air is analyzed for the following VOCs:
Acetaldehyde Acetic acid Acetic acid, methyl ester Acetone Acetonitrile Acetophenone Acrolein
alpha-Pinene Benzaldehyde Benzene Benzene, 1-chloro-4-methyl- Benzene, bromopentafluoro-
Benzoic acid Benzonitrile Butanal Butane, 2,3-dimethyl-2,3-dinitro- Butanoic acid, methyl
ester Cyclohexane Cymene Decanal Decane Diethyl carbitol D-Limonene Etanol Ethene,
1,1-dichloro- Ethylbenzene Formamide, N,N-diethyl- Furan, 2-methyl- Furan,
tetrahydro-3-methyl- Heptanal Hexanal Hexane Hexane, 2,2-dimethyl- Hexane, 3-methyl- Hexanoic
acid Isoprene Isopropyl Alcohol Methacrolein Methanol Methylene chloride N-Ethylformamide
Nitrogen gas Nonanal Nonane Octanal Octane p-Cymene Phenol Phthalic anhydride Propane,
1-(methylthio)- p-Xylene Silane, triethylfluoro- Styrene Sulfide, allyl methyl Sulfur dioxide
Tetrahydrofuran Toluene Triethyl phosphate Undecanal 1,3-Dioxolane, 2-methyl-
1-Dodecene
1. H-Pyrrole, 1-ethyl- 1-Propene, 1-(methylthio)-, (E)- 1-Propene, 2-methyl-
2,2-Dimethoxybutane 2,3-Butanedione 2-Butanone 2-Ethylacrolein 2-Pentanone 2-Propanol,
2-methyl- 3-Pentanone 5-Hepten-2-one, 6-methyl-
