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Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function in Healthy Non Smokers.

Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function in Healthy Non Smokers.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03995329
Enrollment
25
Registered
2019-06-24
Start date
2019-06-19
Completion date
2019-07-10
Last updated
2020-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heated Tobacco, Respiratory Function, Tobacco Toxicity

Keywords

pulmonary function, heated tobacco, IQOS

Brief summary

IQOS (I-Quit-Ordinary-Smoking,) is a type of heat-not-burn (HNB) tobacco product. There is evidence of a growing number of young people who try IQOS as a 'safe' alternative of cigarette. The effect of the acute exposure to IQOS smoke on pulmonary function of healthy non smokers has not been studied extensively. Objectives: Evaluation of the acute effects of IQOS on pulmonary function,exhaled CO, O2 Saturation, arterial pressure and heart rate. Methods: Healthy non smokers, underwent exhaled CO measurement, spirometry including flows, volumes and diffusion capacity, and measurement of their respiratory resistances at 5, 10 and 20 Hz (R5Hz, R10Hz and R20Hz) with the use of an impulse oscillometry system (IOS) before and after the use of an IQOS. Additionally heart rate and arterial blood pressure were also measured.

Detailed description

All participants underwent pulmonary function tests (PFT) (MasterScreen PFT, Jaeger, Wurzburg, Germany) and total respiratory resistances measurement with an impulse oscillometry system (IOS)( (Viasys Jaeger MasterScreen IOS system).From the basic pulmonary measurements (flows and dynamic lung volumes), Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), Tiffenau index (FEV1/FVC, FEV1%), Peak Expiratory Flow (PEF), Maximal Expiratory Flow (MEF) at 25%, 50%, and 75% of vital capacity, Functional Residual Capacity (FRC), Total Lung Capacity (TLC), Residual Volume (RV), Diffusion Capacity (DLCO) were measured. Each manoeuvre was repeated for at least three technically acceptable forced expiratory flow curves in order to attain the best results. Respiratory impedance at 5 Hz (Z5Hz) and respiratory resistance at 5, 10, and 20 Hz (R5Hz, R10Hz, and R20Hz, respectively), reactance at 5, 10, and 20 Hz and resonant frequency were assessed with IOS. Heart rate, saturation of O2 (oxymetry) and arterial blood pressure were also measured. Exhaled CO measurement (piCO Smokerlyzer,Bedfont Scientific Ltd, Kent, U.K.) was performed After smoking heated tobacco (IQOS): 5 minutes after smoking IQOS , they repeated again PFTs, IOS, exhaled CO heart rate, saturation of O2 (oximetry) and arterial blood pressure measurements.

Interventions

OTHERIQOS

Acute effects of IQOS on pulmonary function, oxygen saturation, exhaled CO, heart rate and arterial blood pressure.

Sponsors

Aristotle University Of Thessaloniki
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1. Healthy male non smokers, 2. Age 18-55 years 3. receiving no medications 4. no co morbidity -

Exclusion criteria

1. aged \<18 years 2. smokers or ex-smokers 3. receiving any medications 4. any co morbidity -

Design outcomes

Primary

MeasureTime frameDescription
Forced Expiratory Volume in 1 secondimmediately (max 5 min)Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in:Forced Expiratory Volume in 1 second (FEV1), (liters)
Heart rateimmediately (max 5 min)Heart rate prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Heart rate were measured by oximetry
Forced Vital Capacityimmediatly (max 5 min)Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in:Forced Vital Capacity (FVC), (liters)
Tiffenau indeximmediately (max 5 min)Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Tiffenau index (FEV1/FVC, FEV1%)
Peak Expiratory Flowimmediately (max 5 min)Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Peak Expiratory Flow (PEF), (liters/second )
Exhaled COimmediately (max 5 min)Exhaled CO prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Exhaled CO were measured by (piCO Smokerlyzer) (ppm)
Functional Residual Capacity (FRC)immediately (max 5 min)Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in:Functional Residual Capacity (FRC), (liters)
Total Lung Capacity (TLC)immediately (max 5 min)Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Total Lung Capacity (TLC), (liters)
Residual Volume (RV)immediately (max 5 min)Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Residual Volume (RV), (liters)
Diffusion Capacity (DLCO)immediately (max 5 min)Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Diffusion Capacity (DLCO) ((mmol/min/kPa)
Respiratory impedanceimmediately (max 5 min)Total respiratory resistances measurement with an impulse oscillometry system (IOS)( (Viasys Jaeger MasterScreen IOS system) prior to smoking heated tobacco IQOS and 5 minutes after smoking IQOS were performed. The changes in: Respiratory impedance at 5 Hz (Z5Hz) (kPa/L/sec) were assessed
Total respiratory resistancesimmediately (max 5 min)Total respiratory resistances measurement with an impulse oscillometry system (IOS)( (Viasys Jaeger MasterScreen IOS system) prior to smoking heated tobacco IQOS and 5 minutes after smoking IQOS were performed. The changes in: respiratory resistance at 5 (R5Hz),10 Hz (R10Hz),20 Hz (R20Hz) (kPa/L/sec) were assessed
Arterial Blood Pressureimmediately (max 5 min)Arterial Blood Pressure prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Arterial Blood Pressure were measured (mmHg)
Oxygen Saturationimmediately (max 5 min)Oxygen Saturation prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Oxygen Saturation were measured by oximetry

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026