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

E-cigarettes Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03153228
• Other study ID #: IPU-DIMPA-WUM13(2)
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 12, 2017
• Last updated: May 12, 2017
• Start date: May 8, 2017
• Est. completion date: October 2018

Study information

• Verified date: May 2017
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 87
• Est. completion date: October 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• E-cigarettes

Locations

Country	Name	City	State
Poland	Medical University of Warsaw, Banacha Hospital	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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