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

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ClinicalTrials.gov Identifier: NCT03889990
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
George Papanicolaou Hospital
Information provided by (Responsible Party):
Athanasia Pataka, Aristotle University Of Thessaloniki

Study Description
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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.


Condition or disease Intervention/treatment Phase
Heated Tobacco Respiratory Function Tobacco Toxicity Device: 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.

After smoking heated tobacco (IQOS): 5 minutes after smoking IQOS , they repeated again PFTs and IOS measurements.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 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
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arms and Interventions
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Arm Intervention/treatment
healthy smokers

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

Intervention: the use of an IQOS

 Device: IQOS
"Smoke" IQOS


Outcome Measures
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Primary Outcome Measures :
  1. Forced Expiratory Volume in 1 second [ Time Frame: 5 minutes after smoking IQOS ]
    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: 5 minutes after smoking IQOS ]
    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: 5 minutes after smoking IQOS ]
    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: 5 minutes after smoking IQOS ]
    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. Maximal Expiratory Flow (MEF) [ Time Frame: 5 minutes after smoking IQOS ]
    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 )

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

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

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

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

  10. Respiratory impedance [ Time Frame: 5 minutes after smoking IQOS ]

    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


  11. Total respiratory resistances [ Time Frame: 5 minutes after smoking IQOS ]

    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



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT03889990


Locations
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Greece
Respiratory Failure Unit, G Papanikolaou Hospital, Aristotle Unioversity of Thessaloniki
Thessaloníki, Greece, 57010
Sponsors and Collaborators
Aristotle University Of Thessaloniki
George Papanicolaou Hospital
More Information
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Responsible Party: Athanasia Pataka, Assistant Professor of Respiratory Medicine, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03889990    
Other Study ID Numbers: 8/22.2.2017, 369
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
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
IQOS
heated tobacco