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

NCT03889990 | Completed

• 1 other identifier: 8/22.2.2017, 369
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heated Tobacco; Respiratory Function; Tobacco Toxicity

Keywords

pulmonary function; IQOS; heated tobacco

Outcome Measures

Primary Outcomes (11)

• Forced Expiratory Volume in 1 second

  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)

  5 minutes after smoking IQOS

• Forced Vital Capacity

  Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in:Forced Vital Capacity (FVC), (liters)

  5 minutes after smoking IQOS

• Tiffenau index

  Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Tiffenau index (FEV1/FVC, FEV1%)

  5 minutes after smoking IQOS

• Peak Expiratory Flow

  Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Peak Expiratory Flow (PEF), (liters/second )

  5 minutes after smoking IQOS

• Maximal Expiratory Flow (MEF)

  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 )

  5 minutes after smoking IQOS

• Functional Residual Capacity (FRC)

  Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in:Functional Residual Capacity (FRC), (liters)

  5 minutes after smoking IQOS

• Total Lung Capacity (TLC)

  Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Total Lung Capacity (TLC), (liters)

  5 minutes after smoking IQOS

• Residual Volume (RV)

  Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Residual Volume (RV), (liters)

  5 minutes after smoking IQOS

• Diffusion Capacity (DLCO)

  Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Diffusion Capacity (DLCO) ((mmol/min/kPa)

  5 minutes after smoking IQOS

• Respiratory impedance

  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

  5 minutes after smoking IQOS

• Total respiratory resistances

  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

  5 minutes after smoking IQOS

Study Arms (1)

healthy smokers

OTHER

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

Device: IQOS

Interventions

IQOS DEVICE

"Smoke" IQOS

healthy smokers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• aged \<18 years
• pregnant
• receiving any medications
• any co morbidity

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• George Papanicolaou Hospital: collaborator

Study Sites (1)

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

Thessaloniki, 57010, Greece

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Respiratory Medicine

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 26, 2019
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)