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

NCT ID: NCT03995329

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2019-07-10

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.

Conditions

Heated Tobacco; Respiratory Function; Tobacco Toxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

healthy non smokers

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

Group Type: OTHER

IQOS

Intervention Type: OTHER

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

Interventions

IQOS

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

Intervention Type: OTHER

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Athanasia Pataka

Assistant Professor of Respiratory Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

G Papanicolaou Hospital

Thessaloniki, Thessaloniki, Greece

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

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

762.18/06/2019

Identifier Type: -

Identifier Source: org_study_id