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

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Completed
• CT.gov ID: NCT03995329
• Collaborator: (none)
• Enrollment: 25
• Locations: 2
• Arm: 1
• Actual Duration (Days): 21
• Patients Per Site: 12.5
• Patients Per Site Per Month: 18.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heated Tobacco; Respiratory Function; Tobacco Toxicity	Other: IQOS	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function in Healthy Non Smokers.
• Actual Study Start Date: Jun 19, 2019
• Actual Primary Completion Date: Jul 10, 2019
• Actual Study Completion Date: Jul 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Other: IQOS; Acute effects of IQOS on pulmonary function, oxygen saturation, exhaled CO, heart rate and arterial blood pressure.

Outcome Measures

Primary Outcome Measures

1. Forced Expiratory Volume in 1 second [immediately (max 5 min)]

   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)

2. Forced Vital Capacity [immediatly (max 5 min)]

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

3. Tiffenau index [immediately (max 5 min)]

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

4. Peak Expiratory Flow [immediately (max 5 min)]

   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. Functional Residual Capacity (FRC) [immediately (max 5 min)]

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

6. Total Lung Capacity (TLC) [immediately (max 5 min)]

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

7. Residual Volume (RV) [immediately (max 5 min)]

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

8. Diffusion Capacity (DLCO) [immediately (max 5 min)]

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

9. Respiratory impedance [immediately (max 5 min)]

   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

10. Total respiratory resistances [immediately (max 5 min)]

    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

11. Arterial Blood Pressure [immediately (max 5 min)]

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

12. Oxygen Saturation [immediately (max 5 min)]

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

13. Heart rate [immediately (max 5 min)]

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

14. Exhaled CO [immediately (max 5 min)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	G Papanicolaou Hospital	Thessaloníki	Thessaloniki	Greece	57010
2	Respiratory Failure Unit, G Papanikolaou Hospital, Aristotle Unioversity of Thessaloniki	Thessaloníki		Greece	57010

Sponsors and Collaborators

• Aristotle University Of Thessaloniki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Athanasia Pataka, Assistant Professor of Respiratory Medicine, Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT03995329
• Other Study ID Numbers: 762.18/06/2019
• First Posted: Jun 24, 2019
• Last Update Posted: Jan 9, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Athanasia Pataka, Assistant Professor of Respiratory Medicine, Aristotle University Of Thessaloniki: pulmonary function; heated tobacco; IQOS

Study Results

No Results Posted as of Jan 9, 2020