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Nanoparticles Emitted by Aircraft Engines, Impact on Respiratory Function (NPAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098784
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborators:
Aix Marseille Université
LBM- Nanosecurity platform - CEA Grenoble
LR2N - Nanosecurity platform - CEA Grenoble
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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). 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.

Condition or disease Intervention/treatment
Respiratory Function Other: Exposure to aircraft exhaust Other: Non exposure to aircraft exhaust

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Study Type : Observational
Actual Enrollment : 472 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Nanoparticles Emitted by Aircraft Engines, Impact on Respiratory Function
Study Start Date : November 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Group/Cohort Intervention/treatment
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

Other: Exposure to aircraft exhaust
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.

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

Other: Non exposure to aircraft exhaust
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Exhaled CO measurement [ Time Frame: 1 day (Day of inclusion (D0) ]
    Exhaled CO measurement

  2. Exhaled NO measurement [ Time Frame: 1 day (Day of inclusion (D0) ]
    Exhaled NO measurement

  3. Exhaled air condensate [ Time Frame: 1 day (Day of inclusion (D0) ]
    Exhaled air condensate

  4. oxidative stress marker (8 isoprostane) [ Time Frame: 1 day (Day of inclusion (D0) ]
    oxidative stress marker (8 isoprostane)

  5. plasma mass spectrometry which allows the simultaneous assaying of 17 elements [ Time Frame: 1 day (Day of inclusion (D0) ]
    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)

  6. Lung function [ Time Frame: 1 day (Day of inclusion (D0) ]
    Spirometry value



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Air France employees working in the Marseilles or Parisian airports (flightline and administrative employees)
Criteria

Inclusion Criteria:

  • Subject must be given free and informed consent and signed the consent
  • Subject must be affiliated or beneficiary in a health insurance plan

Exclusion Criteria:

  • Subject has a cons-indication (or an incompatible combination therapy) for the realization of the EFR

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098784


Sponsors and Collaborators
University Hospital, Montpellier
Aix Marseille Université
LBM- Nanosecurity platform - CEA Grenoble
LR2N - Nanosecurity platform - CEA Grenoble
Investigators
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Study Director: NICOLAS MOLINARI University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03098784    
Other Study ID Numbers: 8755
2011-A00646-35 ( Other Identifier: RCB number )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NC
Keywords provided by University Hospital, Montpellier:
airport environment
Air France
flightline employees
administrative employees