NCT03102684

Brief Summary

Limited studies have evaluated potential exposure to secondhand e-cigarette aerosol, an indication of impact on indoor air quality. Also limited are the studies regarding direct passive exposure of humans and most of these studies have limitations, such as the small number of participants, the different methodology and devices used, or the fact that they are laboratory studies, where exposure parameters differ significantly from the actual user's habit and device. Therefore, TackSHS Project has foreseen an intervention study of cross-over design in similar to real-life conditions that aims to assess the mediating effect of e-cigarette battery output on pulmonary outcomes and indexes to provide a better understanding of the extent to which passive exposure to aerosols produced by use of e-cigarette impacts exhaled NO and exhaled breath condensate metabolites.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

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

September 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

March 3, 2017

Last Update Submit

May 10, 2017

Conditions

Second Hand Tobacco Smoke

Keywords

e-cigaretteelectronic cigarettepassive exposuresecondhand exposuresmokingrespiratory system

Outcome Measures

Primary Outcomes (2)

  • Mechanical functions of respiratory system

    By means of impulse oscillometry system (IOS) the following idicators will be measured: Respiratory system total Impedance (Z5), Resistance (R5, R10, R20), Reactance (X5, X10, X20), Resonant Frequency (Rf), Frequency dependence of resistance (fdr), Area AX.

    The measurements (IOS, FeNO, EBC) will be performed in each trial arm immediately after the exposure; the 30 minutes time frame applies for the collective measurements and it is the time needed to perform all 3 tests according to the ATS/ERS guidelines.

  • Fraction of Exhaled Nitric Oxide (FeNO)

    Measurement of airway eosinofilic inflammation

    The measurements (IOS, FeNO, EBC) will be performed in each trial arm immediately after the exposure; the 30 minutes time frame applies for the collective measurements and it is the time needed to perform all 3 tests according to the ATS/ERS guidelines.

Secondary Outcomes (1)

  • Exhaled Breath Condensate (EBC)

    The measurements (IOS, FeNO, EBC) will be performed in each trial arm immediately after the exposure; the 30 minutes time frame applies for the collective measurements and it is the time needed to perform all 3 tests according to the ATS/ERS guidelines.

Study Arms (3)

No exposure

NO INTERVENTION

No exposure to secondhand exposure to aerosols produced by e-cigarettes

Low exposure

EXPERIMENTAL

Secondhand exposure to e-cigarette aerosols (low)

Other: Secondhand exposure to e-cigarette aerosols (low)

High exposure

EXPERIMENTAL

Secondhand exposure to e-cigarette aerosols (high)

Other: Secondhand exposure to e-cigarette aerosols (high)

Interventions

Secondhand exposure to e-cigarette aerosols (low)OTHER

Participants will be exposed to secondhand aerosols produced by e-cigarette use. E-cigarette with low resistance will be used by an experienced smoker (tobacco flavor liquid, 12 mg nicotine, 4 sec puffs, 20-30 seconds inter-puff interval). Duration of exposure: 30 minutes. All study subjects will participate in this arm as the study has a cross-over design.

Low exposure
Secondhand exposure to e-cigarette aerosols (high)OTHER

Participants will be exposed to secondhand aerosols produced by e-cigarette use. E-cigarette with high resistance will be used by an experienced smoker (tobacco flavor liquid, 12 mg nicotine, 4 sec puffs, 20-30 seconds inter-puff interval). Duration of exposure: 30 minutes. All study subjects will participate in this arm as the study has a cross-over design.

High exposure

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For non-smokers:
  • Age 18-35
  • Non-smokers (exhaled CO measurement before each session), or
  • Ex-smokers (\> 1 year)
  • Healthy as by non-significant medical history, normal physical examination and flow volume loop within predicted normal limits (ATS/ERS Task Force 2005)
  • Normal BMI\< 30
  • For e-cigarette users
  • Age 18-35
  • Normal BMI\< 30
  • Experienced e-cig users:\>2 months use
  • Healthy as by non-significant medical history, normal physical examination and flow volume loop within predicted normal limits (ATS/ERS Task Force 2005)

You may not qualify if:

  • For non-smokers
  • Smokers of all kinds and devices, ex-smokers (\< 1 year)
  • Age \<18, \>35
  • BMI\>30
  • Pregnancy, lactation
  • Ongoing or recent illness (\<4 weeks prior to study), recent infection (\<4 weeks)
  • Acute or chronic condition or disease (diabetes, asthma, COPD, congenital heart disease, arrhythmia, hypertension…)
  • Medication of any kind (\<2 weeks prior to study)
  • For e-cigarette users
  • Non-smokers
  • Age \<18, \>35
  • BMI\>30
  • Pregnancy, lactation
  • Ongoing or recent illness (\<4 weeks prior to study), recent infection (\<4 weeks).
  • Acute or chronic condition or disease (diabetes, asthma, COPD, congenital heart disease, arrhythmia, hypertension…)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"George D Behrakis RESEARCH LAB" of the Hellenic Cancer Society (HCS)

Athens, 1152, Greece

Location

Related Publications (1)

  • Tzortzi A, Teloniatis SI, Matiampa G, Bakelas G, Vyzikidou VK, Vardavas C, Behrakis PK, Fernandez E. Passive exposure to e-cigarette emissions: Immediate respiratory effects. Tob Prev Cessat. 2018 May 7;4:18. doi: 10.18332/tpc/89977. eCollection 2018.

    PMID: 32411845DERIVED

Related Links

MeSH Terms

Conditions

VapingSmoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Anna Tzortzi, MD,FCCP

    Hellenic Cancer Society

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2017

First Posted

April 6, 2017

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

October 1, 2019

Last Updated

May 11, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)