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

NCT03995329 | Completed

• 1 other identifier: 762.18/06/2019
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Heated Tobacco; Respiratory Function; Tobacco Toxicity

Keywords

pulmonary function; heated tobacco; IQOS

Outcome Measures

Primary Outcomes (14)

• 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)

  immediately (max 5 min)

• 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)

  immediatly (max 5 min)

• 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%)

  immediately (max 5 min)

• 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 )

  immediately (max 5 min)

• 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)

  immediately (max 5 min)

• 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)

  immediately (max 5 min)

• 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)

  immediately (max 5 min)

• 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)

  immediately (max 5 min)

• 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

  immediately (max 5 min)

• 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

  immediately (max 5 min)

• Arterial Blood Pressure

  Arterial Blood Pressure prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Arterial Blood Pressure were measured (mmHg)

  immediately (max 5 min)

• Oxygen Saturation

  Oxygen Saturation prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Oxygen Saturation were measured by oximetry

  immediately (max 5 min)

• Heart rate

  Heart rate prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Heart rate were measured by oximetry

  immediately (max 5 min)

• Exhaled CO

  Exhaled CO prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Exhaled CO were measured by (piCO Smokerlyzer) (ppm)

  immediately (max 5 min)

Study Arms (1)

healthy non smokers

OTHER

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

Other: IQOS

Interventions

IQOS OTHER

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

healthy non smokers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male non smokers,
• Age 18-55 years
• receiving no medications
• no co morbidity -

You may not qualify if:

• aged \<18 years
• smokers or ex-smokers
• receiving any medications
• any co morbidity -

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (2)

G Papanicolaou Hospital

Thessaloniki, Thessaloniki, 57010, Greece

Location

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: June 20, 2019
• First Posted: June 24, 2019
• Study Start: June 19, 2019
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)