Nanoparticles Emitted by Aircraft Engines, Impact on the Respiratory Function:

NCT02872727 | Terminated DMC

• 2 other identifiers: 96372015-A01771-48
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

The object of this new project is to proceed with investigations with the employees of the cohort for the first study so as to obtain a remote evolution (5 years) of their respiratory function while measuring their nanoparticle exposure. This will enable us to assess the possible link between exposure and respiratory function evolution in the employees

Conditions

Air France Company's Employees Working in the Marseilles and Paris Airports (Flightline and Administrative Employees)

Outcome Measures

Primary Outcomes (1)

• respiratory function

  maximum expiratory volume per second (MEVS)

  1 day (Day of inclusion (D0))

Secondary Outcomes (5)

• 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))

Study Arms (1)

Air France Company's Employees Working

Observational cohort : Air France Company's Employees Working in the Marseilles and Paris Airports having Respiratoy health, biological investigations

Other: Respiratoy health, biological investigations

Interventions

Respiratoy health, biological investigations OTHER

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 (and their evolution since the first study) will be collected. Therefore, the volunteers' participation is limited to one single visit including non-invasive examinations and self-surveys.

Air France Company's Employees Working

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All subjects previously included in our previous study (RBC No: 2011-A00646-35; NCT03098784).

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
• Subject included in our previous study (RBC No: 2011-A00646-35; NCT03098784)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Aix Marseille Université: collaborator
• LBM- Nanosecurity platform - CEA Grenoble: collaborator
• LR2N - Nanosecurity platform - CEA Grenoble: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled air and urine samples.

Study Officials

• NICOLAS MOLINARI

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 19, 2016
• Study Start: December 13, 2017
• Primary Completion: December 13, 2020
• Study Completion: June 13, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

FR (1)