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
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Tracking Information | |||||
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First Submitted Date ICMJE | March 19, 2019 | ||||
First Posted Date ICMJE | March 26, 2019 | ||||
Last Update Posted Date | March 26, 2019 | ||||
Actual Study Start Date ICMJE | January 1, 2018 | ||||
Actual Primary Completion Date | January 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function | ||||
Official Title ICMJE | Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE | Device: IQOS
"Smoke" IQOS
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Study Arms ICMJE | healthy smokers
Healthy smokers males, aged >18years, with >10 pack/years,receiving no medications Intervention: the use of an IQOS Intervention: Device: IQOS
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
40 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | January 1, 2019 | ||||
Actual Primary Completion Date | January 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Greece | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03889990 | ||||
Other Study ID Numbers ICMJE | 8/22.2.2017, 369 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Athanasia Pataka, Aristotle University Of Thessaloniki | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Aristotle University Of Thessaloniki | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | George Papanicolaou Hospital | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Aristotle University Of Thessaloniki | ||||
Verification Date | March 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |