Completed

NCT Number: NCT03889990

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

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.

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Key information

Conditions

Heated Tobacco Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Function Respiratory Tract Diseases Tobacco Toxicity

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory Failure Unit, G Papanikolaou Hospital, Aristotle Unioversity of Thessaloniki

Thessaloniki, 57010, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy smokers,
>10 pack/years
receiving no medications
no co morbidity

Exclusion criteria

aged <18 years
pregnant
receiving any medications
any co morbidity

Treatment and study plan

IQOS

Device

"Smoke" IQOS

Primary outcomes

Forced Expiratory Volume in 1 second

Time frame: 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

Time frame: 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)
Tiffenau index

Time frame: 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%)
Peak Expiratory Flow

Time frame: 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)

Time frame: 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 )
Functional Residual Capacity (FRC)

Time frame: 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)
Total Lung Capacity (TLC)

Time frame: 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)

Time frame: 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)
Diffusion Capacity (DLCO)

Time frame: 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)
Respiratory impedance

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

George Papanicolaou Hospital

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Mar 26, 2019
Registry last updated: Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed