Acute Response to Cigarette and E-cigarette Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and E-cigarettes

Study Overview
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Brief Summary
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Electronical cigarettes, also known as e-cigarettes are a new phenomenon, which steadily wins more aprobation among smokers. However, there exists no much data concerning the effects of acute exposure to electronic cigarettes vapour on the respiratory system. The aim of the present study is to evaluate and compare the acute response to electronic and traditional cigarettes in healthy smokers.

Detailed Description
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The aim of the study is: to evaluate the acute response to traditional cigarettes on the respiratory system to evaluate the acute response to electronic cigarettes on the respiratory system to assess the relationship between the type of smoked cigarettes (traditional vs. electronic) and concentration of markers of airway inflammation released in healthy smokers Material and methods: 29 healthy smokers of traditional cigarettes 29 healthy smokers of electronic cigarettes 29 healthy, nonsmoking volunteers After 8 hours of smoking abstinence: the spirometry test the first collection of the exhaled breath condensate (EBC I) smoking a traditional / electronic cigarette the second collection of the exhaled breath condensate (EBC II) - one hour after smoking the third collection of the exhaled breath condensate (EBC III) - six hours after smoking the measurement of biomarkers of oxidative stress in the EBC (isoprostane-8, malondialdehyde MDA, IL-8) and pH of the EBC

Official Title
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The Comparison of Biomarkers of Acute Response to Cigarette Smoking and E-cigarettes Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and Electronical Cigarettes.

Conditions
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E-cigarettes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy smokers of traditional cigarettes - min. 1 packyear healthy smokers of e-cigarettes - min. 1 year of smoking history control group - healthy nonsmoking volunteers without any history of lung disease Exclusion Criteria: age below 18 years inhaled corticosteroid therapy at least 6 weeks prior to study enrollment any co-morbidities respiratory infections at least 6 weeks prior to study enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smokers of traditional cigarettes<br>29 healthy smokers of traditional cigarettes (min. 1 packyear) | |
| Smokers of e-cigarettes<br>29 healthy smokers of e-cigarettes (min. 1 packyear) | |
| Control<br>29 healthy volunteers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers in exhaled breath condensate | Inflammatory markers in exhaled breath condensate in healthy subjects, smokers of traditional cigarettes and e-cigarette smokers | Approximately 1-2 months after completion of study procedures in all patients | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E-cigarettes