Clinical trial NCT03889990: Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function
Official title: Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heated Tobacco
Respiratory Function
Tobacco Toxicity
Keywords: pulmonary function
IQOS
heated tobacco
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: George Papanicolaou Hospital
First posted: 2019-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Forced Expiratory Volume in 1 second
timeFrame: 5 minutes after smoking IQOS
measure: Forced Vital Capacity
timeFrame: 5 minutes after smoking IQOS
measure: Tiffenau index
timeFrame: 5 minutes after smoking IQOS
measure: Peak Expiratory Flow
timeFrame: 5 minutes after smoking IQOS
measure: Maximal Expiratory Flow (MEF)
timeFrame: 5 minutes after smoking IQOS
measure: Functional Residual Capacity (FRC)
timeFrame: 5 minutes after smoking IQOS
measure: Total Lung Capacity (TLC)
timeFrame: 5 minutes after smoking IQOS
measure: Residual Volume (RV)
timeFrame: 5 minutes after smoking IQOS
measure: Diffusion Capacity (DLCO)
timeFrame: 5 minutes after smoking IQOS
measure: Respiratory impedance
timeFrame: 5 minutes after smoking IQOS
measure: Total respiratory resistances
timeFrame: 5 minutes after smoking IQOS
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Respiratory Failure Unit, G Papanikolaou Hospital, Aristotle Unioversity of Thessaloniki
Study officials:
References: