Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function

Not Applicable

Completed

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

• Registration Number: NCT03889990
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

Background: IQOS ("I-Quit-Ordinary-Smoking,") is a type of the growing class of "heat-not-burn" (HNB) tobacco products. The effect of the acute exposure to IQOS smoke on the pulmonary function of healthy smokers has not been studied extensively.

Objectives: Evaluation of the acute effects of IQOS on pulmonary function.

Methods: Healthy non symptomatic 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 15 min after the use of an IQOS.

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.

After smoking heated tobacco (IQOS): 5 minutes after smoking IQOS , they repeated again PFTs and IOS measurements.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-22
• Last Update Submitted: 2019-03-22
• Study First Posted: 2019-03-26
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Healthy smokers,
2. >10 pack/years
3. receiving no medications
4. no co morbidity

Exclusion Criteria

1. aged <18 years
2. pregnant
3. receiving any medications
4. any co morbidity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy smokers	IQOS	Healthy smokers males, aged \>18years, with \>10 pack/years,receiving no medications Intervention: the use of an IQOS

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 second	5 minutes after smoking IQOS	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)
Forced Vital Capacity	5 minutes after smoking IQOS	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)	5 minutes after smoking IQOS	Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Diffusion Capacity (DLCO) ((mmol/min/kPa)
Tiffenau index	5 minutes after smoking IQOS	Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Tiffenau index (FEV1/FVC, FEV1%)
Functional Residual Capacity (FRC)	5 minutes after smoking IQOS	Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in:Functional Residual Capacity (FRC), (liters)
Respiratory impedance	5 minutes after smoking IQOS	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 resistances	5 minutes after smoking IQOS	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
Peak Expiratory Flow	5 minutes after smoking IQOS	Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Peak Expiratory Flow (PEF), (liters/second )
Maximal Expiratory Flow (MEF)	5 minutes after smoking IQOS	Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Maximal Expiratory Flow (MEF) at 25%, 50%, and 75% of vital capacity,(liters/second )
Total Lung Capacity (TLC)	5 minutes after smoking IQOS	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)	5 minutes after smoking IQOS	Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Residual Volume (RV), (liters)

Trial Locations

Locations (1)

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