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Trial record 2 of 5 for:    TackSHS

Impact of Secondhand Exposure to E-cigarettes Aerosols on the Respiratory System (TackSHSWP6)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03102684
First Posted: April 6, 2017
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hellenic Cancer Society
Agència de Salut Pública de Barcelona
Information provided by (Responsible Party):
Institut Català d'Oncologia
  Purpose
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.

Condition Intervention
Second Hand Tobacco Smoke Other: Secondhand exposure to e-cigarette aerosols (low) Other: Secondhand exposure to e-cigarette aerosols (high)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Impact of Secondhand Exposure to Aerosols Produced by E-cigarettes on the Respiratory System (TackSHS Project)

Resource links provided by NLM:


Further study details as provided by Institut Català d'Oncologia:

Primary Outcome Measures:
  • Mechanical functions of respiratory system [ Time Frame: 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. ]
    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.

  • Fraction of Exhaled Nitric Oxide (FeNO) [ Time Frame: 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. ]
    Measurement of airway eosinofilic inflammation


Secondary Outcome Measures:
  • Exhaled Breath Condensate (EBC) [ Time Frame: 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. ]
    8 isoprostane measurement as a means for oxidative stress evaluation


Estimated Enrollment: 40
Study Start Date: September 2016
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No exposure
No exposure to secondhand exposure to aerosols produced by e-cigarettes
Experimental: Low exposure
Secondhand exposure to e-cigarette aerosols (low)
Other: Secondhand exposure to e-cigarette aerosols (low)

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.

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

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.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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…)
  • Medication of any kind (<2 weeks prior to study)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102684


Locations
Greece
"George D Behrakis RESEARCH LAB" of the Hellenic Cancer Society (HCS)
Athens, Greece, 1152
Sponsors and Collaborators
Institut Català d'Oncologia
Hellenic Cancer Society
Agència de Salut Pública de Barcelona
Investigators
Principal Investigator: Anna Tzortzi, MD,FCCP Hellenic Cancer Society
  More Information

Additional Information:
Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT03102684     History of Changes
Other Study ID Numbers: TackSHS WP6
First Submitted: March 3, 2017
First Posted: April 6, 2017
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Català d'Oncologia:
e-cigarette
electronic cigarette
passive exposure
secondhand exposure
smoking
respiratory system

Additional relevant MeSH terms:
Respiratory System Agents