Second Hand Smoke ExposurePhase 1NCT01988467
The Protective Role of the Nose During Acute Exposure to Passive Smoking.
A Phase 1 study testing exposure to second hand smoking in people with Second Hand Smoke Exposure, run by Hellenic Anticancer Society at 1 site in Greece.
Trial summary
The aim of this study was to compare the acute effects of second hand smoke exposure between nasal and oral breathing and to assess the potential protective role of the nose during acute exposure, in exposure conditions similar to those within a bar where smoking is permitted. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Second Hand Smoke Exposure
- What is being tested?
- exposure to second hand smoking
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGreece
- Study dates
- Aug 2011to Jul 2013
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer adults non-smokers
Who cannot join
- < 18 years old
- Recent or chronic disease of the upper or lower respiratory system.
- Current pregnancy
- Breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to compare the acute effects of second hand smoke exposure between nasal and oral breathing and to assess the potential protective role of the nose during acute exposure, in exposure conditions similar to those within a bar where smoking is permitted.
Read the detailed description
Analysis of the laboratory testing:
The measurement of NO for the respiratory tract was performed with a Ecomedics CLD 88spNO analyzer as follows: the examinee performed tidal breathing with a closed nose, through a special mouthpiece and then took a deep breath and exhale steadily with a flow of 50ml/sec. After 3 attempts, during which we obtained an exhaled NO measurement each time, until we obtained a reliability index CV <10%.
For the oscillometry (IOS) of the respiratory tract the Master Screen IOS VIASYS was used, the examinee breathed quietly through the mouthpiece with his/her nose closed for a period of 1 minute. In this way we measured the impedance Z at 5 Hz, the resistance to 5,10,20 Hz respectively, the reactance in 5,10,20 Hz respectively, the central and peripheral airway resistance and resonant frequency.
Rhinomanometry was done by the Master Screen IOS VIASYS system, the examinee breathed calmly through the examined nostril, while the other was closed, 5 breaths per attempt were performed. After 3 attempts for each nostril, we assessed the average inspiratory resistance for each nostril separately.
The plethysmography took place on the Master Screen Body of VIASYS, the door of the Body was closed as well as all the doors of the room and without the presence of motion in the test room. The subject performed calm breaths with a closed nose, through the mouthpiece and then took a deep breath, followed by deep exhalation. At the end of the effort we had values for the total lung capacity (TLC), residual volume (RV), airway resistance (R), vital capacity (VC), the functional residual capacity (FRC), Exhaled residual volume (ERV) and the ratio RV / TLC. This was repeated 3 times and one was selected to be the most representative.
The P.100 was performed through the Master Screen Body of VIASYS with the door of the Body Box opened. The volunteer was performing calm breaths with a closed nose, through the mouthpiece, during which a shutter blocked the flow. The obtained value of the pressure was the one that developed in the first second of inhalation with the shutter down is noted. This repeated 3 times and one selected to be the most representative.
Spirometry and the flow-volume curve were assessed with a Master Screen Body of VIASYS with the door of the Body Box opened as follows: The subject performed tidal breathing with a closed nose, through the mouthpiece, and then took a sharp deep breath, which was followed by sharp deep exhalation, and the test ended with deep inhalation. At the end of the effort we had values for forced vital capacity (FVC), the violent expiratory the first volume 1 (FEV1), the ratio FVC/FEV1%, peak expiratory flow (PEF) and mesoexpiratory flow in peripheral airways than 25% to 75% of vital capacity. This was repeated 3 times and one was selected to be the most representative.
The assessment of the type of breathing during exposure to secondhand smoke was performed through the VIASYS Respitrace. The protocol was as follows: The volunteer breathed calmly over 20 times with the mouth closed and once with a closed nose, while wearing two rubber bands, one on the chest and one to the abdomen, which incorporates electrodes. The waveform of the breath in the thorax, abdomen and the average of these was recorded in real time. Also, for every breath we had values for the inspiratory time, expiratory time, total time, the participation rate of the chest, the participation rate of the ventricle, the peak inspiratory flow (Pif), the mean inspiratory flow (Mif), and the flow-volume curve and the analysis chart of each breath in the thoracic and abdominal component.
- Conditions
- Second Hand Smoke Exposure
- Being tested
- exposure to second hand smoking
- Keywords
- nasal breathing, oral breathing, secondhand smoking,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to second hand smokingOther
The duration of the exposure to second hand smoke both days was for 20 minutes within a 250mgr/m3 concentration box room. A smoking machine was used, which mimics the smoker (up to 6 breaths per minute in tobacco volume 80ml for each inhalation). The exposure was sometimes with closed mouth and others with closed nose in random sequence.
| Study group | Role | What they receive |
|---|---|---|
| nasal breathing | Experimental | At the time that the exposure took place with nasal breathing, the study was as follows:
Before the exposure: rhinomanometry, IOS , FeNO , spirometry, plethysmography, P.100.
Exposure to second hand smoking:Each volunteer was exposed to secondhand smoking twice, for 20 minutes, once with nasal breathing and once with oral breathing, with 3 days interval and in random sequence.
After the exposure: rhinomanometry, IOS , FeNO , spirometry,plethysmography , P.100. Receives: Other: exposure to second hand smoking |
| oral breathing | Experimental | At the time that the exposure took place with oral breathing, the study was as follows:
Before the exposure: IOS, exhaled nitric oxide (FeNO), spirometry, plethysmography and P.100.
Exposure to second hand smoking: each volunteer was exposed to secondhand smoking twice, for 20 minutes, once with nasal breathing and once with oral breathing, with 3 days interval and in random sequence.
After the exposure: IOS, FeNO, spirometry,plethysmography and P.100. Receives: Other: exposure to second hand smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
exhaled nitric oxide (FeNO) for the respiratory tract
To compare the changes between the two types of breathing
Measured: before exposure (Baseline) and after exposure with a 30 minutes interval
plethysmography
plethysmography take place both at oral and nasal breathing twice before and after intervention.
Measured: before exposure (Baseline) and after exposure with a 30 minutes interval
Secondary outcomes (1)
Eye or nose irritation
During the exposure to second hand smoke that lasted 20 minutes the examinee had his /her mouth closed and filled in an evaluation Questionnaire about eye or nose irritation.
Measured: during the exposure to second hand smoke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startAug 2011
- Primary completionFeb 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Second Hand Smoke ExposureStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Anticancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Sponsor
- Investigators
- Panagiotis K Behrakis, Professor, Study chair, National and Kapodistrian University of AthensPalagia M Karas, MD, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988467
- Sponsor's protocol ID
- 6322/6.3.13
- Status last verified
- Nov 2013
- First submitted
- 28 Oct 2013
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vardavas CI, Anagnostopoulos N, Kougias M, Evangelopoulou V, Connolly GN, Behrakis PK. Acute pulmonary effects of sidestream secondhand smoke at simulated car concentrations. Xenobiotica. 2013 Jun;43(6):509-13. doi: 10.3109/00498254.2012.741272. Epub 2012 Dec 4.
PubMed 23205567Vardavas CI, Anagnostopoulos N, Kougias M, Evangelopoulou V, Connolly GN, Behrakis PK. Short-term pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance, impedance, and exhaled nitric oxide. Chest. 2012 Jun;141(6):1400-1406. doi: 10.1378/chest.11-2443. Epub 2011 Dec 22.
PubMed 22194587
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Role of the Nose During Acute Exposure to Passive Smoking.
- ClinicalTrials.gov ID
- NCT01988467
- Acronym / sponsor ID
- 6322/6.3.13
- Conditions
- Second Hand Smoke Exposure
- Keywords
- nasal breathing, oral breathing, secondhand smoking,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hellenic Anticancer SocietyUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Nov 2013 (estimated)
- 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.
The aim of this study was to compare the acute effects of second hand smoke exposure between nasal and oral breathing and to assess the potential protective role of the nose during acute exposure, in exposure conditions similar to those within a bar where smoking is permitted.
Detailed description
Analysis of the laboratory testing:
The measurement of NO for the respiratory tract was performed with a Ecomedics CLD 88spNO analyzer as follows: the examinee performed tidal breathing with a closed nose, through a special mouthpiece and then took a deep breath and exhale steadily with a flow of 50ml/sec. After 3 attempts, during which we obtained an exhaled NO measurement each time, until we obtained a reliability index CV <10%.
For the oscillometry (IOS) of the respiratory tract the Master Screen IOS VIASYS was used, the examinee breathed quietly through the mouthpiece with his/her nose closed for a period of 1 minute. In this way we measured the impedance Z at 5 Hz, the resistance to 5,10,20 Hz respectively, the reactance in 5,10,20 Hz respectively, the central and peripheral airway resistance and resonant frequency.
Rhinomanometry was done by the Master Screen IOS VIASYS system, the examinee breathed calmly through the examined nostril, while the other was closed, 5 breaths per attempt were performed. After 3 attempts for each nostril, we assessed the average inspiratory resistance for each nostril separately.
The plethysmography took place on the Master Screen Body of VIASYS, the door of the Body was closed as well as all the doors of the room and without the presence of motion in the test room. The subject performed calm breaths with a closed nose, through the mouthpiece and then took a deep breath, followed by deep exhalation. At the end of the effort we had values for the total lung capacity (TLC), residual volume (RV), airway resistance (R), vital capacity (VC), the functional residual capacity (FRC), Exhaled residual volume (ERV) and the ratio RV / TLC. This was repeated 3 times and one was selected to be the most representative.
The P.100 was performed through the Master Screen Body of VIASYS with the door of the Body Box opened. The volunteer was performing calm breaths with a closed nose, through the mouthpiece, during which a shutter blocked the flow. The obtained value of the pressure was the one that developed in the first second of inhalation with the shutter down is noted. This repeated 3 times and one selected to be the most representative.
Spirometry and the flow-volume curve were assessed with a Master Screen Body of VIASYS with the door of the Body Box opened as follows: The subject performed tidal breathing with a closed nose, through the mouthpiece, and then took a sharp deep breath, which was followed by sharp deep exhalation, and the test ended with deep inhalation. At the end of the effort we had values for forced vital capacity (FVC), the violent expiratory the first volume 1 (FEV1), the ratio FVC/FEV1%, peak expiratory flow (PEF) and mesoexpiratory flow in peripheral airways than 25% to 75% of vital capacity. This was repeated 3 times and one was selected to be the most representative.
The assessment of the type of breathing during exposure to secondhand smoke was performed through the VIASYS Respitrace. The protocol was as follows: The volunteer breathed calmly over 20 times with the mouth closed and once with a closed nose, while wearing two rubber bands, one on the chest and one to the abdomen, which incorporates electrodes. The waveform of the breath in the thorax, abdomen and the average of these was recorded in real time. Also, for every breath we had values for the inspiratory time, expiratory time, total time, the participation rate of the chest, the participation rate of the ventricle, the peak inspiratory flow (Pif), the mean inspiratory flow (Mif), and the flow-volume curve and the analysis chart of each breath in the thoracic and abdominal component.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal breathing | Experimental | Other: exposure to second hand smokingAt the time that the exposure took place with nasal breathing, the study was as follows: Before the exposure: rhinomanometry, IOS , FeNO , spirometry, plethysmography, P.100. Exposure to second hand smoking:Each volunteer was exposed to secondhand smoking twice, for 20 minutes, once with nasal breathing and once with oral breathing, with 3 days interval and in random sequence. After the exposure: rhinomanometry, IOS , FeNO , spirometry,plethysmography , P.100. |
| oral breathing | Experimental | Other: exposure to second hand smokingAt the time that the exposure took place with oral breathing, the study was as follows: Before the exposure: IOS, exhaled nitric oxide (FeNO), spirometry, plethysmography and P.100. Exposure to second hand smoking: each volunteer was exposed to secondhand smoking twice, for 20 minutes, once with nasal breathing and once with oral breathing, with 3 days interval and in random sequence. After the exposure: IOS, FeNO, spirometry,plethysmography and P.100. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteer adults non-smokers
Key exclusion criteria (4 listed)
- < 18 years old
- Recent or chronic disease of the upper or lower respiratory system.
- Current pregnancy
- Breastfeeding women
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 |
|---|---|---|
| exposure to second hand smokingThe duration of the exposure to second hand smoke both days was for 20 minutes within a 250mgr/m3 concentration box room. A smoking machine was used, which mimics the smoker (up to 6 breaths per minute in tobacco volume 80ml for each inhalation). The exposure was sometimes with closed mouth and others with closed nose in random sequence. | Other | nasal breathing, oral breathing |
Primary outcome
exhaled nitric oxide (FeNO) for the respiratory tract
Time frame: before exposure (Baseline) and after exposure with a 30 minutes interval
To compare the changes between the two types of breathing
plethysmography
Time frame: before exposure (Baseline) and after exposure with a 30 minutes interval
plethysmography take place both at oral and nasal breathing twice before and after intervention.
1 secondary outcome
Eye or nose irritation
Time frame: during the exposure to second hand smoke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
- Background: PubMed 23205567Vardavas CI, Anagnostopoulos N, Kougias M, Evangelopoulou V, Connolly GN, Behrakis PK. Acute pulmonary effects of sidestream secondhand smoke at simulated car concentrations. Xenobiotica. 2013 Jun;43(6):509-13. doi: 10.3109/00498254.2012.741272. Epub 2012 Dec 4.
- Background: PubMed 22194587Vardavas CI, Anagnostopoulos N, Kougias M, Evangelopoulou V, Connolly GN, Behrakis PK. Short-term pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance, impedance, and exhaled nitric oxide. Chest. 2012 Jun;141(6):1400-1406. doi: 10.1378/chest.11-2443. Epub 2011 Dec 22.
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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.
Panagiotis K Behrakis, Professor study chair
National and Kapodistrian University of Athens
Palagia M Karas, MD principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing exposure to second hand smoking in people with Second Hand Smoke Exposure, run by Hellenic Anticancer Society 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 20 Nov 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
exhaled nitric oxide (FeNO) for the respiratory tract (time frame: before exposure (Baseline) and after exposure with a 30 minutes interval). 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 NCT01988467, which also lists 2 linked publications.
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 20 Nov 2013.