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

Not Applicable

Completed

• Conditions: Heated Tobacco; Respiratory Function; Tobacco Toxicity
• Interventions: Other: IQOS

• Registration Number: NCT03995329
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2019-06-19
• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-24
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy non smokers	IQOS	Healthy non smokers males, aged 18-55years,receiving no medications Intervention: the use of an IQOS Examination of pulmonary function, exhaled CO, blood pressure, heart rate and O2 saturation immediatly after IQOS

Primary Outcome Measures

Name	Time	Method
Peak Expiratory Flow	immediately (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 )
Forced Expiratory Volume in 1 second	immediately (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)
Tiffenau index	immediately (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%)
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)
Forced Vital Capacity	immediatly (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)
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)
Total respiratory resistances	immediately (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
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)
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)
Oxygen Saturation	immediately (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
Heart rate	immediately (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
Respiratory impedance	immediately (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
Arterial Blood Pressure	immediately (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)
Exhaled CO	immediately (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)

Trial Locations

Locations (2)

G Papanicolaou Hospital; 🇬🇷 Thessaloníki, Thessaloniki, Greece

Respiratory Failure Unit, G Papanikolaou Hospital, Aristotle Unioversity of Thessaloniki; 🇬🇷 Thessaloníki, Greece