PASSIVE SMOKING ,Phase 1NCT02171871
Effects Of Passive Smoking On The Respiratory System Mechanics Of Healthy Non-Smokers In Different Body Positions
A Phase 1 study testing exposed to a smoking environment in people with PASSIVE SMOKING , and RESPIRATORY SYSTEM MECHANICS,, run by Hellenic Anticancer Society at 1 site in Greece.
Trial summary
The study will examine changes in the respiratory system mechanics and in respiratory physiology after exposure of subjects to passive smoking. It is about healthy non-smoking volunteers and it will be carried out through the techniques of forced oscillation with Impulse Oscillometry (IOS) technique methodology and… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- PASSIVE SMOKING ,, RESPIRATORY SYSTEM MECHANICS,
- What is being tested?
- exposed to a smoking environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2010to May 2014
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer, adults, non-smokers
Who cannot join
- < 18 years old , Current pregnancy, Breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
The study will examine changes in the respiratory system mechanics and in respiratory physiology after exposure of subjects to passive smoking. It is about healthy non-smoking volunteers and it will be carried out through the techniques of forced oscillation with Impulse Oscillometry (IOS) technique methodology and nitrogen washout.
The present study will contribute to the understanding of passive smoking consequences on the respiratory system of healthy non-smokers. Thanks to the nitrogen washout technique, changes to closing volume and closing capacity will be examined during measurement in different positions (sitting, decubitus) together with exposure to passive smoking. With IOS methodology, changes in respiratory system resistance in four positions (standing, sitting, right and left lateral decubitus) will be evaluated before and after exposure to a passive smoking environment. Results of the present study are expected to provide interesting information on the changes in measured parameters not only in different positions but also after exposure to smoking.
Read the detailed description
Methodology
For the current study the following techniques will be used. Impulse Oscillometry (IOS) methodology constitutes a method of studying the respiratory system mechanics, during which the investigators manage to determine the flow resistance, the capacity resistance and the resonant frequency through the application of multifrequent signals. It also offers the possibility of studying the mechanics of central and peripheral respiratory system.
The nitrogen washout technique is a method of indirect measurement of the functional residual capacity, during which exhaled nitrogen is measured after the subject has breathed oxygen of a 100% density. A single breath nitrogen washout contributes to the measurement of closing volume and closing capacity.
Emitted particles, detected in a smoking environment, will be measured with the SIDEPAK AM510, which is a measurement device of particles based on their diameter.
The research will be conducted according to the following procedure. Healthy non-smoking volunteers (18-40 years old) will be subject, after giving their brief medical history, to IOS and to the nitrogen washout test. The IOS will be conducted in four positions (standing, sitting, right and left lateral decubitus), whereas the nitrogen washout test in two (sitting and decubitus).
Then the subject will be exposed to a smoking environment for 20 minutes, under a continuous measurement of emitted particles using the SIDEPAK AM510 in Pm level 2,5=250, in a closed space of 20 m3. The passive smoking environment will be achieved via a smoking machine. Afterwards, the subject will again undergo IOS in four positions (standing, sitting, right and left lateral decubitus) and nitrogen washout test in two positions (sitting and decubitus). Thanks to the above mentioned techniques, changes in measured parameters will be evaluated.
- Conditions
- PASSIVE SMOKING ,, RESPIRATORY SYSTEM MECHANICS,
- Being tested
- exposed to a smoking environment
- Keywords
- EFFECTS,, PASSIVE SMOKING ,, RESPIRATORY SYSTEM MECHANICS,, DIFFERENT BODY POSITIONS.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposed to a smoking environmentOther
Also called EFFECTS OF PASSIVE SMOKING, RESPIRATORY SYSTEM MECHANICS
Then the subjects will be exposed to a smoking environment for 20 minutes, under a continuous measurement of emitted particles using the SIDEPAK AM510 in Pm level 2,5=250, in a closed space of 20 m3. The passive smoking environment will be achieved via a smoking machine. Afterwards, the subject will again undergo IOS in four positions (standing, sitting, right and left lateral decubitus) and nitrogen washout test in two positions (sitting and decubitus). Thanks to the above mentioned techniques, changes in measured parameters will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | Experimental | Healthy non-smoking volunteers (18-40 years old) will be subject, after giving their brief medical history, to IOS and to the nitrogen washout test. The IOS will be conducted in four positions (standing, sitting, right and left lateral decubitus), whereas the nitrogen washout test in two (sitting and decubitus).
Then the subjects will be exposed to a smoking environment for 20 minutes. Receives: Other: exposed to a smoking environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of IOS in four positions (standing, sitting, right and left lateral decubitus)
IOS methodology constitutes a method of studying the respiratory system mechanics, during which we manage to determine the flow resistance, the capacity resistance and the resonant frequency through the application of multifrequent signals. It also offers the possibility of studying the mechanics of central and peripheral respiratory system.
Measured: before exposure (Baseline) and after exposure to passive smoking with a 5 minutes interval at one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionMay 2014
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 PASSIVE SMOKING ,Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 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, Hellenic Anticancer Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171871
- Sponsor's protocol ID
- PBCS003
- Status last verified
- Jun 2014
- First submitted
- 3 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Behrakis PK, Baydur A, Jaeger MJ, Milic-Emili J. Lung mechanics in sitting and horizontal body positions. Chest. 1983 Apr;83(4):643-6. doi: 10.1378/chest.83.4.643.
PubMed 6831953Stathopoulou H , Vardavas C, Matsunaga Y , Kairi O , Anagnostopoulos N, Karras P , Agaku I, Loukopoulou A, Tzwrtzi A, Behrakis P. The effect of body position during short term exposure to secondhand smoke on pulmonary resistance and impedance using impulse osscilometry European Conference on Tobacco or Health, Istanbul. March 2014
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Passive Smoking On The Respiratory System Mechanics Of Healthy Non-Smokers In Different Body Positions
- ClinicalTrials.gov ID
- NCT02171871
- Acronym / sponsor ID
- PBCS003
- Conditions
- PASSIVE SMOKING ,, RESPIRATORY SYSTEM MECHANICS,
- Keywords
- EFFECTS,, PASSIVE SMOKING ,, RESPIRATORY SYSTEM MECHANICS,, DIFFERENT BODY POSITIONS.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hellenic Anticancer SocietyUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Jun 2014 (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 study will examine changes in the respiratory system mechanics and in respiratory physiology after exposure of subjects to passive smoking. It is about healthy non-smoking volunteers and it will be carried out through the techniques of forced oscillation with Impulse Oscillometry (IOS) technique methodology and nitrogen washout.
The present study will contribute to the understanding of passive smoking consequences on the respiratory system of healthy non-smokers. Thanks to the nitrogen washout technique, changes to closing volume and closing capacity will be examined during measurement in different positions (sitting, decubitus) together with exposure to passive smoking. With IOS methodology, changes in respiratory system resistance in four positions (standing, sitting, right and left lateral decubitus) will be evaluated before and after exposure to a passive smoking environment. Results of the present study are expected to provide interesting information on the changes in measured parameters not only in different positions but also after exposure to smoking.
Detailed description
Methodology
For the current study the following techniques will be used. Impulse Oscillometry (IOS) methodology constitutes a method of studying the respiratory system mechanics, during which the investigators manage to determine the flow resistance, the capacity resistance and the resonant frequency through the application of multifrequent signals. It also offers the possibility of studying the mechanics of central and peripheral respiratory system.
The nitrogen washout technique is a method of indirect measurement of the functional residual capacity, during which exhaled nitrogen is measured after the subject has breathed oxygen of a 100% density. A single breath nitrogen washout contributes to the measurement of closing volume and closing capacity.
Emitted particles, detected in a smoking environment, will be measured with the SIDEPAK AM510, which is a measurement device of particles based on their diameter.
The research will be conducted according to the following procedure. Healthy non-smoking volunteers (18-40 years old) will be subject, after giving their brief medical history, to IOS and to the nitrogen washout test. The IOS will be conducted in four positions (standing, sitting, right and left lateral decubitus), whereas the nitrogen washout test in two (sitting and decubitus).
Then the subject will be exposed to a smoking environment for 20 minutes, under a continuous measurement of emitted particles using the SIDEPAK AM510 in Pm level 2,5=250, in a closed space of 20 m3. The passive smoking environment will be achieved via a smoking machine. Afterwards, the subject will again undergo IOS in four positions (standing, sitting, right and left lateral decubitus) and nitrogen washout test in two positions (sitting and decubitus). Thanks to the above mentioned techniques, changes in measured parameters will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | Experimental | Other: exposed to a smoking environmentHealthy non-smoking volunteers (18-40 years old) will be subject, after giving their brief medical history, to IOS and to the nitrogen washout test. The IOS will be conducted in four positions (standing, sitting, right and left lateral decubitus), whereas the nitrogen washout test in two (sitting and decubitus). Then the subjects will be exposed to a smoking environment for 20 minutes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteer, adults, non-smokers
Key exclusion criteria (1 listed)
- < 18 years old , 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 |
|---|---|---|
| exposed to a smoking environmentAlso: EFFECTS OF PASSIVE SMOKING, RESPIRATORY SYSTEM MECHANICSThen the subjects will be exposed to a smoking environment for 20 minutes, under a continuous measurement of emitted particles using the SIDEPAK AM510 in Pm level 2,5=250, in a closed space of 20 m3. The passive smoking environment will be achieved via a smoking machine. Afterwards, the subject will again undergo IOS in four positions (standing, sitting, right and left lateral decubitus) and nitrogen washout test in two positions (sitting and decubitus). Thanks to the above mentioned techniques, changes in measured parameters will be evaluated. | Other | CONTROL GROUP |
Primary outcome
change of IOS in four positions (standing, sitting, right and left lateral decubitus)
Time frame: before exposure (Baseline) and after exposure to passive smoking with a 5 minutes interval at one time point
IOS methodology constitutes a method of studying the respiratory system mechanics, during which we manage to determine the flow resistance, the capacity resistance and the resonant frequency through the application of multifrequent signals. It also offers the possibility of studying the mechanics of central and peripheral respiratory system.
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 24 Jun 2014.
- Background: PubMed 6831953Behrakis PK, Baydur A, Jaeger MJ, Milic-Emili J. Lung mechanics in sitting and horizontal body positions. Chest. 1983 Apr;83(4):643-6. doi: 10.1378/chest.83.4.643.
- Results publicationStathopoulou H , Vardavas C, Matsunaga Y , Kairi O , Anagnostopoulos N, Karras P , Agaku I, Loukopoulou A, Tzwrtzi A, Behrakis P. The effect of body position during short term exposure to secondhand smoke on pulmonary resistance and impedance using impulse osscilometry European Conference on Tobacco or Health, Istanbul. March 2014
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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
Hellenic Anticancer Society
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 exposed to a smoking environment in people with PASSIVE SMOKING , and RESPIRATORY SYSTEM MECHANICS,, 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 1 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 24 Jun 2014. 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?
change of IOS in four positions (standing, sitting, right and left lateral decubitus) (time frame: before exposure (Baseline) and after exposure to passive smoking with a 5 minutes interval at one time point). 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 NCT02171871, 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 24 Jun 2014.