Second Hand Tobacco SmokeTackSHSWP6NCT03102684
Impact of Secondhand Exposure to E-cigarettes Aerosols on the Respiratory System
A study testing Secondhand exposure to e-cigarette aerosols (low) and Secondhand exposure to e-cigarette aerosols (high) in people with Second Hand Tobacco Smoke, run by Institut Català d'Oncologia at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Second Hand Tobacco Smoke
- What is being tested?
- Secondhand exposure to e-cigarette aerosols (low) and Secondhand exposure to e-cigarette aerosols (high)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2016to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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)
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Greece1 site
"George D Behrakis RESEARCH LAB" of the Hellenic Cancer Society (HCS)
Athens, 1152
About this study
Official title: Clinical Impact of Secondhand Exposure to Aerosols Produced by E-cigarettes on the Respiratory System (TackSHS Project)
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.
Read the detailed description
This study is a part of a larger research project (TackSHS) funded by the European Union's Horizon 2020 Research and Innovation Programme (Grant Agreement No 681040). The current study main aim is to assess the impact of passive exposure to aerosols produced by use of e-cigarettes on indexes of lung function (respiratory mechanics and exhaled biomarkers) among healthy adults.
To achieve this objective, a laboratory based intervention study of cross-over design will be conducted at the "George D Behrakis RESEARCH LAB" of the Hellenic Cancer Society. Specifically, three trial arms will be performed (no exposure to e-cigarette aerosols (1) vs. low e-cigarette aerosols exposure (2) vs. high e-cigarette aerosols exposure (3)) with each subject participating in each of the three trial arms. Each trial arm is based around two battery power outputs, one of the key factors related to the production of e-cigarette aerosols.
Sample size:
The study sample will be 40 participants. The participants will be randomized to a sequence of exposures, and thus all the participants are requested to participate in all three trial-arms. In total, 120 person-exposures will take place (3 trial-arms x 40 adults) during the duration of this study, leading to 240 pre and post measurements.
Study Population:
Recruitment will take place within a community setting in Athens (Greece) among volunteers. Two types of participants are requested:
- Healthy non-smokers - to be exposed to e-cigarette aerosols (secondhand exposure)
- Healthy e-cigarette users - to create the e-cigarette exposure
Intervention
An intervention for the arms 2 and 3 will be a 30-minute exposure to aerosols produced by use of e-cigarette by an experienced user. The difference between arm 2 and 3 exposure would lie in distinct opposition to electric current of the e-cigarette battery (resistance), in particularly, low (arm 2) and high (arm 3) battery resistance will be used. Each volunteer will be given appropriate information on exposure and health effects.
Measurements:
The following measurements will be performed at each arm:
- Exhaled CO
- Oscillometry
- Exhaled NO (FeNO)
- Exhaled Breath Condensate (EBC)
- Environmental measurements - PM1, PM2.5
Equipment to be used:
- Bedfont microsmokelyser
- Sidepak TSI
- Viasys, Vmax series body-box system
- Viasys, Jaeger Masterscreen IOS system: (heated pneumotach, resistance=0.05 kPa/(L/s) at 10 L/s), in line with ATS/ERS task force guidelines 2005 25
- ECO Medics, AG CLD 88 chemilluminescense, Spiroware 3.021
- Turbo-Deccs EBC
- Thermoscientific Deepfreezer
Exposures will take place within a standardized exposure chamber successfully used with similar protocols for exposure to secondhand tobacco smoke from conventional cigarettes. The chamber will allow to control for the environmental conditions of exposures and verify that the measures changes in outcomes will be attributable solely to the trial-arm.
All individuals taking part, will be informed by the responsible physician, regarding the study, the specific tests they are about to undergo, their procedure, clinical significance and impact.
The investigators will also provide answers to any possible questions, as well as information regarding the following issues:
- The purpose of the information to be collected, including aims, methods and implications of the research;
- The extent to which personal data is used and accessed by various partners (it will be made clear that all data pertaining to them is stored and handled in an anonymous manner using encrypted - not personally identifiable- codes);
- The participant's right to access personal data and/or study data; and
- The participant's right to withdraw from participation in the study, at any point, without consequences and without obligation of explanation or justification
If the individual agrees to participate, the participant will have to confirm this by reading the information sheets and providing consent to the researcher.
The results of the medical tests included in this study, will be given to all participants along with the corresponding diagnostic interpretation.
All individuals participating in this study can freely access their own personal data, but it will be made clear to the study participants that no research results from the project will be returned to the subjects. However, data related to the entire project will be publicly disseminated once it has been processed and protected. This will be accessed through the project website or through publications related to this project.
It will be made clear that the subjects are completely free to withdraw their records from participation at any time. It will be made clear that the consent given by participants in the project can be withdrawn at any time, without any explanation or justification. In this case all data pertaining to the subjects in question will be destroyed.
The results of the medical tests included in this study, will be given to all participants along with the corresponding diagnostic interpretation.
All individuals participating in this study can freely access their own personal data, but it will be made clear to the study participants that no research results from the project will be returned to the subjects. However, data related to the entire project will be publicly disseminated once it has been processed and protected. This will be accessed through the project website or through publications related to this project.
All measurements will be conducted by trained clinical researchers. Besides the information about sociodemographic characteristics, data on smoking consumption and e-cigarette use and other tobacco variables will be also collected.
Data will be saved in electronic format and protected by password. Only a selected number of pre- designated members of the data collection team will have access to these laptops. Once data collection is complete, all data will be uploaded to a single database and reliably and completely deleted from the laptops. Selected personal data, including the names of respondents, will be collected to enable quality assurance procedures and to allow participants willing to withdraw from participation in the survey to have their records deleted from the database. Once quality assurance procedures are complete (within 4 months of the completion of data collection), names and other unique personal identifiers (such as full address) will be reliably and completely deleted.
Statistical analyses will be focused on identifying both a deterministic effect as also investigation into a potential dose-response effect between lower vs. higher exposures to e-cigarette aerosols. Once the complete dataset of all participants has been merged and cleaned, the data will be analysed using SPSS.
Specific analyses will allow us to investigate the associations between exposure to e-cigarette emissions and
- indexes of lung mechanics (impedance, resistance, reactance, resonant frequency, frequency dependence of resistance)
- exhaled biomarkers (exhaled NO levels and EBC levels of 8-isoprostane). The model will also allow for adjustment of any potential confounding subject-level factors and will provide estimates of within and between subject variance components and correlations.
The TackSHS project is coordinated by Dr. Esteve Fernandez from Institut Catala d'Oncologia (ICO) (SPAIN). This study is managed by the "George D Behrakis RESEARCH LAB", within the Hellenic Cancer Society (HCS) (Greece), with collaboration of the Institut Catala d'Oncologia (ICO) (SPAIN) and the Public Health Agency of Barcelona (ASPB) (SPAIN) as partners.
- Conditions
- Second Hand Tobacco Smoke
- Being tested
- Secondhand exposure to e-cigarette aerosols (low), Secondhand exposure to e-cigarette aerosols (high)
- Keywords
- e-cigarette, electronic cigarette, passive exposure, secondhand exposure, smoking, respiratory system
- Medical subject headings
- Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Secondhand exposure to e-cigarette aerosols (low) |
| High exposure | Experimental | Secondhand exposure to e-cigarette aerosols (high) Receives: Other: Secondhand exposure to e-cigarette aerosols (high) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
8 isoprostane measurement as a means for oxidative stress evaluation
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Second Hand Tobacco SmokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Cancer Society, Public Health Agency of Barcelona
- Responsible party
- Sponsor
- Investigators
- Anna Tzortzi, MD,FCCP, Principal investigator, Hellenic Cancer Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102684
- Sponsor's protocol ID
- TackSHS WP6
- Acronym
- TackSHSWP6
- Status last verified
- May 2017
- First submitted
- 3 Mar 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32411845
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Secondhand Exposure to Aerosols Produced by E-cigarettes on the Respiratory System (TackSHS Project)
- ClinicalTrials.gov ID
- NCT03102684
- Acronym / sponsor ID
- TackSHSWP6 / TackSHS WP6
- Conditions
- Second Hand Tobacco Smoke
- Keywords
- e-cigarette, electronic cigarette, passive exposure, secondhand exposure, smoking, respiratory system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Collaborators
- Hellenic Cancer Society, Public Health Agency of Barcelona
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a part of a larger research project (TackSHS) funded by the European Union's Horizon 2020 Research and Innovation Programme (Grant Agreement No 681040). The current study main aim is to assess the impact of passive exposure to aerosols produced by use of e-cigarettes on indexes of lung function (respiratory mechanics and exhaled biomarkers) among healthy adults.
To achieve this objective, a laboratory based intervention study of cross-over design will be conducted at the "George D Behrakis RESEARCH LAB" of the Hellenic Cancer Society. Specifically, three trial arms will be performed (no exposure to e-cigarette aerosols (1) vs. low e-cigarette aerosols exposure (2) vs. high e-cigarette aerosols exposure (3)) with each subject participating in each of the three trial arms. Each trial arm is based around two battery power outputs, one of the key factors related to the production of e-cigarette aerosols.
Sample size:
The study sample will be 40 participants. The participants will be randomized to a sequence of exposures, and thus all the participants are requested to participate in all three trial-arms. In total, 120 person-exposures will take place (3 trial-arms x 40 adults) during the duration of this study, leading to 240 pre and post measurements.
Study Population:
Recruitment will take place within a community setting in Athens (Greece) among volunteers. Two types of participants are requested:
- Healthy non-smokers - to be exposed to e-cigarette aerosols (secondhand exposure)
- Healthy e-cigarette users - to create the e-cigarette exposure
Intervention
An intervention for the arms 2 and 3 will be a 30-minute exposure to aerosols produced by use of e-cigarette by an experienced user. The difference between arm 2 and 3 exposure would lie in distinct opposition to electric current of the e-cigarette battery (resistance), in particularly, low (arm 2) and high (arm 3) battery resistance will be used. Each volunteer will be given appropriate information on exposure and health effects.
Measurements:
The following measurements will be performed at each arm:
- Exhaled CO
- Oscillometry
- Exhaled NO (FeNO)
- Exhaled Breath Condensate (EBC)
- Environmental measurements - PM1, PM2.5
Equipment to be used:
- Bedfont microsmokelyser
- Sidepak TSI
- Viasys, Vmax series body-box system
- Viasys, Jaeger Masterscreen IOS system: (heated pneumotach, resistance=0.05 kPa/(L/s) at 10 L/s), in line with ATS/ERS task force guidelines 2005 25
- ECO Medics, AG CLD 88 chemilluminescense, Spiroware 3.021
- Turbo-Deccs EBC
- Thermoscientific Deepfreezer
Exposures will take place within a standardized exposure chamber successfully used with similar protocols for exposure to secondhand tobacco smoke from conventional cigarettes. The chamber will allow to control for the environmental conditions of exposures and verify that the measures changes in outcomes will be attributable solely to the trial-arm.
All individuals taking part, will be informed by the responsible physician, regarding the study, the specific tests they are about to undergo, their procedure, clinical significance and impact.
The investigators will also provide answers to any possible questions, as well as information regarding the following issues:
- The purpose of the information to be collected, including aims, methods and implications of the research;
- The extent to which personal data is used and accessed by various partners (it will be made clear that all data pertaining to them is stored and handled in an anonymous manner using encrypted - not personally identifiable- codes);
- The participant's right to access personal data and/or study data; and
- The participant's right to withdraw from participation in the study, at any point, without consequences and without obligation of explanation or justification
If the individual agrees to participate, the participant will have to confirm this by reading the information sheets and providing consent to the researcher.
The results of the medical tests included in this study, will be given to all participants along with the corresponding diagnostic interpretation.
All individuals participating in this study can freely access their own personal data, but it will be made clear to the study participants that no research results from the project will be returned to the subjects. However, data related to the entire project will be publicly disseminated once it has been processed and protected. This will be accessed through the project website or through publications related to this project.
It will be made clear that the subjects are completely free to withdraw their records from participation at any time. It will be made clear that the consent given by participants in the project can be withdrawn at any time, without any explanation or justification. In this case all data pertaining to the subjects in question will be destroyed.
The results of the medical tests included in this study, will be given to all participants along with the corresponding diagnostic interpretation.
All individuals participating in this study can freely access their own personal data, but it will be made clear to the study participants that no research results from the project will be returned to the subjects. However, data related to the entire project will be publicly disseminated once it has been processed and protected. This will be accessed through the project website or through publications related to this project.
All measurements will be conducted by trained clinical researchers. Besides the information about sociodemographic characteristics, data on smoking consumption and e-cigarette use and other tobacco variables will be also collected.
Data will be saved in electronic format and protected by password. Only a selected number of pre- designated members of the data collection team will have access to these laptops. Once data collection is complete, all data will be uploaded to a single database and reliably and completely deleted from the laptops. Selected personal data, including the names of respondents, will be collected to enable quality assurance procedures and to allow participants willing to withdraw from participation in the survey to have their records deleted from the database. Once quality assurance procedures are complete (within 4 months of the completion of data collection), names and other unique personal identifiers (such as full address) will be reliably and completely deleted.
Statistical analyses will be focused on identifying both a deterministic effect as also investigation into a potential dose-response effect between lower vs. higher exposures to e-cigarette aerosols. Once the complete dataset of all participants has been merged and cleaned, the data will be analysed using SPSS.
Specific analyses will allow us to investigate the associations between exposure to e-cigarette emissions and
- indexes of lung mechanics (impedance, resistance, reactance, resonant frequency, frequency dependence of resistance)
- exhaled biomarkers (exhaled NO levels and EBC levels of 8-isoprostane). The model will also allow for adjustment of any potential confounding subject-level factors and will provide estimates of within and between subject variance components and correlations.
The TackSHS project is coordinated by Dr. Esteve Fernandez from Institut Catala d'Oncologia (ICO) (SPAIN). This study is managed by the "George D Behrakis RESEARCH LAB", within the Hellenic Cancer Society (HCS) (Greece), with collaboration of the Institut Catala d'Oncologia (ICO) (SPAIN) and the Public Health Agency of Barcelona (ASPB) (SPAIN) as partners.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No exposure | No intervention | –No exposure to secondhand exposure to aerosols produced by e-cigarettes |
| Low exposure | Experimental | Other: Secondhand exposure to e-cigarette aerosols (low)Secondhand exposure to e-cigarette aerosols (low) |
| High exposure | Experimental | Other: Secondhand exposure to e-cigarette aerosols (high)Secondhand exposure to e-cigarette aerosols (high) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- For non-smokers
- Smokers of all kinds and devices, ex-smokers (< 1 year)
- Age <18, >35
- BMI>30
- Pregnancy, lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Low exposure |
| 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. | Other | High exposure |
Primary outcome
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
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Derived from this study: PubMed 32411845Tzortzi 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.
- TackSHS ProjectLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Tzortzi, MD,FCCP principal investigator
Hellenic Cancer Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secondhand exposure to e-cigarette aerosols (low) and Secondhand exposure to e-cigarette aerosols (high) in people with Second Hand Tobacco Smoke, run by Institut Català d'Oncologia at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.