Respiratory FunctionNPAFNCT03098784
Nanoparticles Emitted by Aircraft Engines, Impact on Respiratory Function
An observational study of Respiratory Function, run by University Hospital, Montpellier.
Trial summary
The goal of this study is to assess the respiratory health of the Air France company's employees working in the Marseilles and Paris airports (flight line and administrative employees). This study was promoted by the Montpellier CHRU, Regional University Hospital Centre (ANSM identification number 2011-A00646-35). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Function
- What is being tested?
- Exposure to aircraft exhaust and Non exposure to aircraft exhaust
- How many people
- 472 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jun 2012
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Air France employees working in the Marseilles or Parisian airports (flightline and administrative employees)
Who may be able to join
- Subject must be given free and informed consent and signed the consent
- Subject must be affiliated or beneficiary in a health insurance plan
Who cannot join
- Subject has a cons-indication (or an incompatible combination therapy) for the realization of the EFR
About this study
The goal of this study is to assess the respiratory health of the Air France company's employees working in the Marseilles and Paris airports (flight line and administrative employees). This study was promoted by the Montpellier CHRU, Regional University Hospital Centre (ANSM identification number 2011-A00646-35). It allowes voluntary employees to be involved. They answer a lifestyle survey and perform a spirometry, an exhaled CO measurement and a sampling of exhaled air condensate (EAC). A metrological study of particles emitted by aircraft engines and found in the airport environment will be conducted and the elementary chemical composition analysis, as well a sieve analysis of particles present in the EAC will be conducted.
Read the detailed description
Air traffic is increasing, raising concern about local pollution and its adverse health effects on the people living in the vicinity of large airports. However, the highest risk is probably occupational exposure due to proximity. Jet exhaust is one of the main concerns at an airport and may have a health impact, particularly on the respiratory tract. Current studies are neither numerous enough nor strong enough to prove this kind of association. Yet, more and more people work in airports, and occupational exposure to jet exhaust is a fact. In 1999, the effect of occupational exposure to aircraft fuel and jet exhaust on pulmonary function and respiratory symptoms in Birmingham International Airport (Birmingham, UK) workers was reported. This work suggested that there was a link between high occupational exposure to aviation fuel or jet exhaust and excess respiratory tract symptoms, consistent with the presence of a respiratory irritant. It was a cross-sectional survey using a questionnaire filled out by the participants themselves. Respiratory and immunological function assessments and an exhaled carbon monoxide measurement were conducted with male full-time airport workers classified into three groups according to their exposure level.
The study will be presented to the volunteering subjects during an occupational medical appointment concerning their company. The information letter will be provided as well as the informed consent form to be filled for the study. Once the subjects have agreed to participate, self-surveys on their lifestyle habits will be filled and EACand urine samplings will be taken during one same consultation, in addition to exhaled CO and No measurements. This consultation will also include a spirometry test. The employees' workstation data will be collected. Therefore, the volunteers' participation is limited to one single visit including non-invasive examinations and self-surveys.
Method details:
- Survey: The survey breaks down into 2 parts, with a total of 94 items. The first part bears on the employees' respiratory health condition, essentially grounded on the validated EGEA survey. The rest focuses on employees' lifestyle habits, both professionally (outdoor and indoor working time, trade, type of exposure, etc.) and personally (geographical situation of the home, type of town or community, heating system, usual mode of cooking, etc.). The survey is anonymised and the answers are automatically read by datascan process.
- Spirometry: This method allows a non-invasive, simple and repeatable assessment of the respiratory function. It is indispensable to clearly explain the process to the patient. The patient sits with his or her back straight during the process. Once the subject and the device are ready, the subject deeply breathes in to fill the lungs then fully expires into the spirometer. Then the subject breathes in fully and forcedly in order to obtain the inspiratory curve. The spirometry results are compared with theoretical or predicted values determined based on patient's age, gender, size and ethnic group. Consequently, according to the subject's breathing speed and force intensity, measurements of vital capacity (VC) or forced vital capacity (FVC) are obtained. The curves will allow the other variables to be deduced, such as maximum expiratory volume per second (MEVS) or peak expiratory flow (PEF), or mean expiratory flows (MEF 25-75).
- Exhaled CO measurement (confounding factors of the respiratory function, in order to reflect the smoking status):the employee blows into the device's single-use cardboard mouthpiece after a deep inspiration followed by a fifteen-second apnea computed by the device. The measurement in part per million (ppm) is immediately displayed on the device to quantify the severity of CO intoxication. This measurement is simple and repeatable.
- Exhaled air condensate:for EAC acquisition. In fact, the RTube device is well adapted to non-invasion collection on the companies' sites. It will be used according to the recommendations from the American Thoracic Society and the EuropeanRespiratory Society. The R tube will be pre-treated as in the first study (intensive washing in order to abate background noise) and "white" R tubeswill be collected all through the study to check the method's detection limit. Briefly, the collection with nose blocked lasts for 15 minutes during which the subject breathes normally through the device. The mouth is rinsed with water before collection and the subject is asked to refrain from drinking or eating during the previous hour. This will allow ca. 1.4 ml to be collected (mean EACvolume collected during the first study over a 15-minute breathing time).
- Metrology:as this is a recent subject, there is no consensus so far on the most representative unit of measurement for employee exposure. Similarly, no current device allows all parameters to be obtained:quantitative data (particle content/cm3, sieve distribution, developed surface area of the alveolar fraction likely to be exposed in the breathing apparatus) and qualitative data (morphology, aggregation/agglomeration status, listof constitutive chemical elements). These experts' surveys require the implementation of different equipment. The method is based on personal metrology, use of portable and individual systems, as well as fixed installation metrology, organised into a single sampling by means of a cane to which the various measuring instruments are connected (Condensation ParticleCounter, ElectrostaticLow Pressure Impactor, Scanning MobilityParticleSizer, FastMobilityParticleSizer, Nanometer Surface Area Monitor, Alveolar Sensor, Alveolar Inhalable Thoracic sensor).An independent counter (Condensation ParticleCounter) allows background evolution to be monitored. Membrane sensors (such as the Giliansampling pump with membrane support) will also complement the process. They will be used as portable systems, on the employees involved in the study. Finally, the samples will be analysed by means of a SEM (Scanning Electron Microscope),model 5500 from Hitachi, associated with an energy-dispersive EDX system (X analysis system - Noranmodel from the Thermocompany).
- Conditions
- Respiratory Function
- Being tested
- Exposure to aircraft exhaust, Non exposure to aircraft exhaust
- Keywords
- airport environment, Air France, flightline employees, administrative employees
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to aircraft exhaustOther
The exposed group is made up of Air France personnel mainly working in physical proximity to the runways of the Marseille Marignane or Parisian airports. These people are subject to direct exposure to exhaust from aircraft engines.
Non exposure to aircraft exhaustOther
The non-exposed group is made up of Air France personnel working mainly inside buildings at the Marseille Marignane or Parisian airports. These people are not subject to direct exposure to exhaust from aircraft engines.
| Study group | Role | What they receive |
|---|---|---|
| Air France employees working near runways | Air France personnel mainly working in physical proximity to the runways of the Marseille Marignane or Parisian airports.
Intervention: Exposure to aircraft exhaust Receives: Other: Exposure to aircraft exhaust | |
| Air France employees working inside | Air France personnel working mainly inside buildings at the Marseille Marignane or Parisian airports.
Intervention: Non exposure to aircraft exhaust Receives: Other: Non exposure to aircraft exhaust |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quantity of nanoparticules present in exhaled air condensate
The quantity of nanoparticules present in exhaled air condensate
Measured: 1 day (Day of inclusion (D0)
Secondary outcomes (6)
Exhaled CO measurement
Exhaled CO measurement
Measured: 1 day (Day of inclusion (D0)
Exhaled NO measurement
Exhaled NO measurement
Measured: 1 day (Day of inclusion (D0)
Exhaled air condensate
Exhaled air condensate
Measured: 1 day (Day of inclusion (D0)
oxidative stress marker (8 isoprostane)
oxidative stress marker (8 isoprostane)
Measured: 1 day (Day of inclusion (D0)
plasma mass spectrometry which allows the simultaneous assaying of 17 elements
plasma mass spectrometry which allows the simultaneous assaying of 17 elements (Zn, Al, Ti, Co, Cu, Zr, Ni, Cr, Ga, In, Mn, Fe, Se, Cd, Ge, Be)
Measured: 1 day (Day of inclusion (D0)
Lung function
Spirometry value
Measured: 1 day (Day of inclusion (D0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startNov 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Aix Marseille Université, LBM- Nanosecurity platform - CEA Grenoble, LR2N - Nanosecurity platform - CEA Grenoble
- Responsible party
- Sponsor
- Investigators
- NICOLAS MOLINARI, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098784
- Sponsor's protocol ID
- 8755
- Other IDs
- 2011-A00646-35
- Acronym
- NPAF
- Status last verified
- Mar 2017
- First submitted
- 23 Aug 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: NC
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanoparticles Emitted by Aircraft Engines, Impact on Respiratory Function
- ClinicalTrials.gov ID
- NCT03098784
- Acronym / sponsor ID
- NPAF / 8755
- Conditions
- Respiratory Function
- Keywords
- airport environment, Air France, flightline employees, administrative employees
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Aix Marseille Université, LBM- Nanosecurity platform - CEA Grenoble, LR2N - Nanosecurity platform - CEA Grenoble
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 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.
The goal of this study is to assess the respiratory health of the Air France company's employees working in the Marseilles and Paris airports (flight line and administrative employees). This study was promoted by the Montpellier CHRU, Regional University Hospital Centre (ANSM identification number 2011-A00646-35). It allowes voluntary employees to be involved. They answer a lifestyle survey and perform a spirometry, an exhaled CO measurement and a sampling of exhaled air condensate (EAC). A metrological study of particles emitted by aircraft engines and found in the airport environment will be conducted and the elementary chemical composition analysis, as well a sieve analysis of particles present in the EAC will be conducted.
Detailed description
Air traffic is increasing, raising concern about local pollution and its adverse health effects on the people living in the vicinity of large airports. However, the highest risk is probably occupational exposure due to proximity. Jet exhaust is one of the main concerns at an airport and may have a health impact, particularly on the respiratory tract. Current studies are neither numerous enough nor strong enough to prove this kind of association. Yet, more and more people work in airports, and occupational exposure to jet exhaust is a fact. In 1999, the effect of occupational exposure to aircraft fuel and jet exhaust on pulmonary function and respiratory symptoms in Birmingham International Airport (Birmingham, UK) workers was reported. This work suggested that there was a link between high occupational exposure to aviation fuel or jet exhaust and excess respiratory tract symptoms, consistent with the presence of a respiratory irritant. It was a cross-sectional survey using a questionnaire filled out by the participants themselves. Respiratory and immunological function assessments and an exhaled carbon monoxide measurement were conducted with male full-time airport workers classified into three groups according to their exposure level.
The study will be presented to the volunteering subjects during an occupational medical appointment concerning their company. The information letter will be provided as well as the informed consent form to be filled for the study. Once the subjects have agreed to participate, self-surveys on their lifestyle habits will be filled and EACand urine samplings will be taken during one same consultation, in addition to exhaled CO and No measurements. This consultation will also include a spirometry test. The employees' workstation data will be collected. Therefore, the volunteers' participation is limited to one single visit including non-invasive examinations and self-surveys.
Method details:
- Survey: The survey breaks down into 2 parts, with a total of 94 items. The first part bears on the employees' respiratory health condition, essentially grounded on the validated EGEA survey. The rest focuses on employees' lifestyle habits, both professionally (outdoor and indoor working time, trade, type of exposure, etc.) and personally (geographical situation of the home, type of town or community, heating system, usual mode of cooking, etc.). The survey is anonymised and the answers are automatically read by datascan process.
- Spirometry: This method allows a non-invasive, simple and repeatable assessment of the respiratory function. It is indispensable to clearly explain the process to the patient. The patient sits with his or her back straight during the process. Once the subject and the device are ready, the subject deeply breathes in to fill the lungs then fully expires into the spirometer. Then the subject breathes in fully and forcedly in order to obtain the inspiratory curve. The spirometry results are compared with theoretical or predicted values determined based on patient's age, gender, size and ethnic group. Consequently, according to the subject's breathing speed and force intensity, measurements of vital capacity (VC) or forced vital capacity (FVC) are obtained. The curves will allow the other variables to be deduced, such as maximum expiratory volume per second (MEVS) or peak expiratory flow (PEF), or mean expiratory flows (MEF 25-75).
- Exhaled CO measurement (confounding factors of the respiratory function, in order to reflect the smoking status):the employee blows into the device's single-use cardboard mouthpiece after a deep inspiration followed by a fifteen-second apnea computed by the device. The measurement in part per million (ppm) is immediately displayed on the device to quantify the severity of CO intoxication. This measurement is simple and repeatable.
- Exhaled air condensate:for EAC acquisition. In fact, the RTube device is well adapted to non-invasion collection on the companies' sites. It will be used according to the recommendations from the American Thoracic Society and the EuropeanRespiratory Society. The R tube will be pre-treated as in the first study (intensive washing in order to abate background noise) and "white" R tubeswill be collected all through the study to check the method's detection limit. Briefly, the collection with nose blocked lasts for 15 minutes during which the subject breathes normally through the device. The mouth is rinsed with water before collection and the subject is asked to refrain from drinking or eating during the previous hour. This will allow ca. 1.4 ml to be collected (mean EACvolume collected during the first study over a 15-minute breathing time).
- Metrology:as this is a recent subject, there is no consensus so far on the most representative unit of measurement for employee exposure. Similarly, no current device allows all parameters to be obtained:quantitative data (particle content/cm3, sieve distribution, developed surface area of the alveolar fraction likely to be exposed in the breathing apparatus) and qualitative data (morphology, aggregation/agglomeration status, listof constitutive chemical elements). These experts' surveys require the implementation of different equipment. The method is based on personal metrology, use of portable and individual systems, as well as fixed installation metrology, organised into a single sampling by means of a cane to which the various measuring instruments are connected (Condensation ParticleCounter, ElectrostaticLow Pressure Impactor, Scanning MobilityParticleSizer, FastMobilityParticleSizer, Nanometer Surface Area Monitor, Alveolar Sensor, Alveolar Inhalable Thoracic sensor).An independent counter (Condensation ParticleCounter) allows background evolution to be monitored. Membrane sensors (such as the Giliansampling pump with membrane support) will also complement the process. They will be used as portable systems, on the employees involved in the study. Finally, the samples will be analysed by means of a SEM (Scanning Electron Microscope),model 5500 from Hitachi, associated with an energy-dispersive EDX system (X analysis system - Noranmodel from the Thermocompany).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air France employees working near runways | – | Other: Exposure to aircraft exhaustAir France personnel mainly working in physical proximity to the runways of the Marseille Marignane or Parisian airports. Intervention: Exposure to aircraft exhaust |
| Air France employees working inside | – | Other: Non exposure to aircraft exhaustAir France personnel working mainly inside buildings at the Marseille Marignane or Parisian airports. Intervention: Non exposure to aircraft exhaust |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Air France employees working in the Marseilles or Parisian airports (flightline and administrative employees)
Key inclusion criteria (2 listed)
- Subject must be given free and informed consent and signed the consent
- Subject must be affiliated or beneficiary in a health insurance plan
Key exclusion criteria (1 listed)
- Subject has a cons-indication (or an incompatible combination therapy) for the realization of the EFR
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 aircraft exhaustThe exposed group is made up of Air France personnel mainly working in physical proximity to the runways of the Marseille Marignane or Parisian airports. These people are subject to direct exposure to exhaust from aircraft engines. | Other | Air France employees working near runways |
| Non exposure to aircraft exhaustThe non-exposed group is made up of Air France personnel working mainly inside buildings at the Marseille Marignane or Parisian airports. These people are not subject to direct exposure to exhaust from aircraft engines. | Other | Air France employees working inside |
Primary outcome
The quantity of nanoparticules present in exhaled air condensate
Time frame: 1 day (Day of inclusion (D0)
The quantity of nanoparticules present in exhaled air condensate
6 secondary outcomes
Exhaled CO measurement
Time frame: 1 day (Day of inclusion (D0)
Exhaled NO measurement
Time frame: 1 day (Day of inclusion (D0)
Exhaled air condensate
Time frame: 1 day (Day of inclusion (D0)
oxidative stress marker (8 isoprostane)
Time frame: 1 day (Day of inclusion (D0)
plasma mass spectrometry which allows the simultaneous assaying of 17 elements
Time frame: 1 day (Day of inclusion (D0)
Lung function
Time frame: 1 day (Day of inclusion (D0)
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 4 Apr 2017.
- Individual participant dataSharing planned: Yes. NC
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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.
NICOLAS MOLINARI study director
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Function, run by University Hospital, Montpellier.
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 2 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The quantity of nanoparticules present in exhaled air condensate (time frame: 1 day (Day of inclusion (D0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2017.