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

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Completed
• CT.gov ID: NCT03889990
• Collaborator: George Papanicolaou Hospital (Other)
• Enrollment: 40
• Location: 1
• Arm: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Jan 1, 2018
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Primary Outcome Measures

1. Forced Expiratory Volume in 1 second [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 [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 [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 [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) [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) [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) [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) [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) [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Respiratory Failure Unit, G Papanikolaou Hospital, Aristotle Unioversity of Thessaloniki	Thessaloníki		Greece	57010

Sponsors and Collaborators

• Aristotle University Of Thessaloniki
• George Papanicolaou Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Mar 26, 2019
• Last Update Posted: Mar 26, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Athanasia Pataka, Assistant Professor of Respiratory Medicine, Aristotle University Of Thessaloniki: pulmonary function; IQOS; heated tobacco

Study Results

No Results Posted as of Mar 26, 2019