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Respiratory FunctionNPAFNCT03098784

Nanoparticles Emitted by Aircraft Engines, Impact on Respiratory Function

An observational study of Respiratory Function, run by University Hospital, Montpellier.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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).
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 groups in NCT03098784
Study groupRoleWhat they receive
Air France employees working near runwaysAir 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 insideAir 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.

  1. 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)
  1. Exhaled CO measurement

    Exhaled CO measurement

    Measured: 1 day (Day of inclusion (D0)

  2. Exhaled NO measurement

    Exhaled NO measurement

    Measured: 1 day (Day of inclusion (D0)

  3. Exhaled air condensate

    Exhaled air condensate

    Measured: 1 day (Day of inclusion (D0)

  4. oxidative stress marker (8 isoprostane)

    oxidative stress marker (8 isoprostane)

    Measured: 1 day (Day of inclusion (D0)

  5. 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)

  6. 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.

  1. First posted4 Apr 2017
  2. Study startNov 2011
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

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)
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

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.

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