Clinical trial NCT03995329: Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function in Healthy Non Smokers.
Official title: Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function in Healthy Non Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heated Tobacco
Respiratory Function
Tobacco Toxicity
Keywords: pulmonary function
heated tobacco
IQOS
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility 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 -

Primary outcomes:
measure: Forced Expiratory Volume in 1 second
timeFrame: immediately (max 5 min)
measure: Forced Vital Capacity
timeFrame: immediatly (max 5 min)
measure: Tiffenau index
timeFrame: immediately (max 5 min)
measure: Peak Expiratory Flow
timeFrame: immediately (max 5 min)
measure: Functional Residual Capacity (FRC)
timeFrame: immediately (max 5 min)
measure: Total Lung Capacity (TLC)
timeFrame: immediately (max 5 min)
measure: Residual Volume (RV)
timeFrame: immediately (max 5 min)
measure: Diffusion Capacity (DLCO)
timeFrame: immediately (max 5 min)
measure: Respiratory impedance
timeFrame: immediately (max 5 min)
measure: Total respiratory resistances
timeFrame: immediately (max 5 min)
measure: Arterial Blood Pressure
timeFrame: immediately (max 5 min)
measure: Oxygen Saturation
timeFrame: immediately (max 5 min)
measure: Heart rate
timeFrame: immediately (max 5 min)
measure: Exhaled CO
timeFrame: immediately (max 5 min)
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: G Papanicolaou Hospital
state: Thessaloniki
city: Thessaloníki
country: Greece
facility: Respiratory Failure Unit, G Papanikolaou Hospital, Aristotle Unioversity of Thessaloniki
Study officials:
References: