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

Medical University of Warsaw

Status: Unknown

Conditions: E-cigarettes

Study type: Observational

Funder types: Other

Identifiers

NCT03153228

IPU-DIMPA-WUM13(2)

Details and patient eligibility

About

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.

Full 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

Enrollment: 87 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

87 participants in 3 patient groups

Smokers of traditional cigarettes

Description:

29 healthy smokers of traditional cigarettes (min. 1 packyear)

Smokers of e-cigarettes

Description:

29 healthy smokers of e-cigarettes (min. 1 packyear)

Control

Description:

29 healthy volunteers.