NCT03153228

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

May 12, 2017

Last Update Submit

May 12, 2017

Conditions

E-cigarettes

Keywords

E-cigarettes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw, Banacha Hospital

Warsaw, 02-097, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

exhaled breath condensate

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2017

First Posted

May 15, 2017

Study Start

May 8, 2017

Primary Completion

July 1, 2018

Study Completion

October 1, 2018

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations

PL(1)