Nanoparticles Emitted by Aircraft Engines, Impact on Respiratory Function
NPAF
2 other identifiers
observational
472
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2011
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 23, 2016
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedApril 4, 2017
March 1, 2017
7 months
August 23, 2016
March 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The quantity of nanoparticules present in exhaled air condensate
The quantity of nanoparticules present in exhaled air condensate
1 day (Day of inclusion (D0)
Secondary Outcomes (6)
Exhaled CO measurement
1 day (Day of inclusion (D0)
Exhaled NO measurement
1 day (Day of inclusion (D0)
Exhaled air condensate
1 day (Day of inclusion (D0)
oxidative stress marker (8 isoprostane)
1 day (Day of inclusion (D0)
plasma mass spectrometry which allows the simultaneous assaying of 17 elements
1 day (Day of inclusion (D0)
- +1 more secondary outcomes
Study Arms (2)
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
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
Interventions
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.
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.
Eligibility Criteria
Air France employees working in the Marseilles or Parisian airports (flightline and administrative employees)
You may qualify if:
- Subject must be given free and informed consent and signed the consent
- Subject must be affiliated or beneficiary in a health insurance plan
You may not qualify if:
- Subject has a cons-indication (or an incompatible combination therapy) for the realization of the EFR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Montpellierlead
- Aix Marseille Universitécollaborator
- LBM- Nanosecurity platform - CEA Grenoblecollaborator
- LR2N - Nanosecurity platform - CEA Grenoblecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
NICOLAS MOLINARI
University Hospital, Montpellier
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2016
First Posted
April 4, 2017
Study Start
November 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
April 4, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
NC