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

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.

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.

Study Overview

• Status: Unknown
• Conditions: E-cigarettes

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 Type: Observational
• Enrollment (Anticipated): 87

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-097
    • Medical University of Warsaw, Banacha Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy smokers of traditional cigarettes, healthy smokers of e-cigarettes, healthy nonsmoking volunteers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Smokers of traditional cigarettes; 29 healthy smokers of traditional cigarettes (min. 1 packyear)
Smokers of e-cigarettes; 29 healthy smokers of e-cigarettes (min. 1 packyear)
Control; 29 healthy volunteers.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: May 12, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: E-cigarettes
• Other Study ID Numbers: IPU-DIMPA-WUM13(2)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No