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

• Conditions: E-cigarettes

• Registration Number: NCT03153228
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

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

Study Timeline

• Status Verified: 2017-05
• Study Start: 2017-05-08
• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-12
• Last Update Submitted: 2017-05-12
• Study First Posted: 2017-05-15
• Last Update Posted: 2017-05-15
• Primary Completion: 2018-07
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Warsaw, Banacha Hospital; 🇵🇱 Warsaw, Poland