NCT03098784

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
472

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

August 23, 2016

Last Update Submit

March 31, 2017

Conditions

Keywords

airport environmentAir Franceflightline employeesadministrative employees

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

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

Other: 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.

Air France employees working near runways

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.

Air France employees working inside

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • NICOLAS MOLINARI

    University Hospital, Montpellier

    STUDY DIRECTOR

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