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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995329
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Athanasia Pataka, Aristotle University Of Thessaloniki

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 19, 2019
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : July 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Forced Expiratory Volume in 1 second [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995329


Locations
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Greece
G Papanicolaou Hospital
Thessaloníki, Thessaloniki, Greece, 57010
Respiratory Failure Unit, G Papanikolaou Hospital, Aristotle Unioversity of Thessaloniki
Thessaloníki, Greece, 57010
Sponsors and Collaborators
Aristotle University Of Thessaloniki
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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: June 24, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Athanasia Pataka, Aristotle University Of Thessaloniki:
pulmonary function
heated tobacco
IQOS