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

NCT ID: NCT03889990

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-01-01

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.

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 smokers

Healthy smokers males, aged >18years, with >10 pack/years,receiving no medications

Intervention: the use of an IQOS

Group Type: OTHER

IQOS

Intervention Type: DEVICE

"Smoke" IQOS

Interventions

IQOS

"Smoke" IQOS

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

George Papanicolaou Hospital

OTHER

Sponsor Role: collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Athanasia Pataka

Assistant Professor of Respiratory Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

8/22.2.2017, 369

Identifier Type: -

Identifier Source: org_study_id