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

Aristotle University Of Thessaloniki

Status: Completed

Conditions: Tobacco Toxicity; Respiratory Function; Heated Tobacco

Treatments: Device: IQOS

Study type: Interventional

Funder types: Other

Identifiers

NCT03889990

8/22.2.2017, 369

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

healthy smokers

Other group

Description:

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

Treatment:

Device: IQOS