Respiratory Function Clinical Trial
Official title:
Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function in Healthy Non Smokers.
Verified date | January 2020 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | July 10, 2019 |
Est. primary completion date | July 10, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
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 - |
Country | Name | City | State |
---|---|---|---|
Greece | G Papanicolaou Hospital | Thessaloníki | Thessaloniki |
Greece | Respiratory Failure Unit, G Papanikolaou Hospital, Aristotle Unioversity of Thessaloniki | Thessaloníki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) |
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