Air France Company's Employees Working in the Marseilles and Paris Airports (Flightline and Administrative Employees)NANOAF2NCT02872727
Nanoparticles Emitted by Aircraft Engines, Impact on the Respiratory Function:
An observational study of Air France Company's Employees Working in the Marseilles and Paris Airports (Flightline and Administrative Employees), run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Air France Company's Employees Working in the Marseilles and Paris Airports (Flightline and Administrative Employees)
- What is being tested?
- Respiratoy health, biological investigations
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2017to 13 Jun 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects previously included in our previous study (RBC No: 2011-A00646-35; NCT03098784).
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
- Subject included in our previous study (RBC No: 2011-A00646-35; NCT03098784)
Who cannot join
- Subject has a cons-indication (or an incompatible combination therapy) for the realization of the EFR.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nanoparticles Emitted by Aircraft Engines, Impact on the Respiratory Function: Cohort Follow-up Study
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
Read the detailed description
It is well known that the nanoparticle (NP) rate is higher in large metropolitan cities but also in the airport environments owing to aircraft engine emissions. Now, this nanoparticulatepollution is a public health issue owing to its potential cardiovascular and respiratory impact on general population. Besides, an evolution of exposure in airport environments is now observed, due to the implementation of new protective equipment better adapted to nanoparticles and to the use of new fuels.
From October 2011 to June 2012, our partnership network conducted a first study on the assessment of the respiratory health of the Air France company'semployees working in the Marseillesand Paris airports (flightline and administrative employees). This study was promoted by the Montpellier CHRU, Regional University Hospital Centre (ANSM identification number 2011-A00646-35). It allowed 471 voluntary employees to be involved. They answered a lifestyle survey and underwent 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 was conducted and the elementary chemical composition analysis, as well a sieve analysis of particles present in the EACwere conducted. The data analysis from this first study (whose publications are currently being drafted) gave rise to a description of the respiratory health condition of the employees working in the vicinity of nanoparticle production sources, and to characterise exposure to nanoparticles of secondary emission originating from aircraft engine exhaust gases, as well as a description of the elementary and particulate content of the EACsin this whole population.
The analysis of the respiratory functions of the exposed subjects combined with the measurement and characterisation of nanoparticlesemitted by aircraft engines (through a metrology data analysis) and with the EACanalysis allowed the measurement of the exposure levels and the assessment of the respiratory health of the employees in an airport environment. Besides, the studied population was located on two airports in two different cities (Roissy Charles de Gaulle for Paris and Marignanefor Marseilles).
So far, no longitudinal follow-up study of airport NPsin a large size sample has been carried out, notably in a plurisdisciplinary scope. Yet only such a longitudinal follow-up analysis of the cohortwill provide a suitable impact study of the various exposure factors, taking into account their integration. Now, no large size cohortof subjects exposed to secondary emission nanoparticlesor ultrafine particles (UFP) has ever been monitored in France.
The first previously conducted study enabled us to draw up a situational respiratory health analysis on 471 employees. It also allowed us to measure nanoparticlesin their exhaled air and to evaluate their UFPexposure rate on the work station. It is now relevant to monitor the evolution of these parameters in the course of time and better assess the role of possibly confounding factors in the evolution of their respiratory health.
The EAC is collected by means of a simple device and is a non-invasive tool providing useful information on lung exposure, or even on inflammatory effects at respiratory tract level. The EACis a good proposed methodology to study exposure and effect biomarkers in professional exposure situations (Mutti 2006; Corradi 2010). Exposure biomarkers such as metals were also studied in the EACin connection with smoking (Mutti 2006) or with professional exposure to metallic particles (Goldoni 2010, Goldoni2004, Hoffmeyer2011). In a recent study, the EACwas used in order to locate nanoparticlesand oxidative stress markers (malondialdehydeand hydrogen peroxide H2O2) in volunteers exposed to cigarette smoke (Sauvain 2014). As the EACis a highly diluted aqueous medium, there is no reported matrix effect. However, one of the difficulties lies in the use of highly sensitive techniques. In the scope of our previous study, the analysis techniques were already implemented and used on the 471 collected EACsamples. The Medical Biology Laboratory of CEA in Grenoble is currently working on methodologies intended to standardise the analyses in this medium (sodium measured in parallel by ICPMS, knowing that standardisation was proposed in the literature: Dompeling 2010) and other methodologies such as total protein assaying by µBCA.
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
- Being tested
- Respiratoy health, biological investigations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratoy health, biological investigationsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Respiratoy health, biological investigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory function
maximum expiratory volume per second (MEVS)
Measured: 1 day (Day of inclusion (D0))
Secondary outcomes (5)
Exhaled CO measurement
Exhaled CO measurement
Measured: 1 day (Day of inclusion (D0))
Exhaled NO measurement
Exhaled NO measurement
Measured: 1 day (Day of inclusion (D0))
Exhaled air condensate
Exhaled air condensate
Measured: 1 day (Day of inclusion (D0))
oxidative stress marker (8 isoprostane)
oxidative stress marker (8 isoprostane)
Measured: 1 day (Day of inclusion (D0))
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))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start13 Dec 2017
- Primary completion13 Dec 2020
- Study completion13 Jun 2021
Why it stopped: Inclusion of the last patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Air France Company's Employees Working in the Marseilles and Paris Airports (Flightline and Administrative Employees)Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Aix Marseille Université, LBM- Nanosecurity platform - CEA Grenoble, LR2N - Nanosecurity platform - CEA Grenoble
- Responsible party
- Sponsor
- Investigators
- NICOLAS MOLINARI, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872727
- Sponsor's protocol ID
- 9637
- Other IDs
- 2015-A01771-48
- Acronym
- NANOAF2
- Status last verified
- Dec 2021
- First submitted
- 16 Aug 2016
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Touri L, Tarantini A, Suehs C, Nogue E, Marie-Desvergne C, Dubosson M, Dauba A, Ravanat JL, Chamel V, Klerlein M, Artous S, Locatelli D, Jacquinot S, Chanez P, Vachier I, Molinari N. Occupational exposure to aerosols in two French airports: multi-year lung function changes. Ann Work Expo Health. 2025 Jan 8;69(1):17-33. doi: 10.1093/annweh/wxae087.
PubMed 39585315
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanoparticles Emitted by Aircraft Engines, Impact on the Respiratory Function: Cohort Follow-up Study
- ClinicalTrials.gov ID
- NCT02872727
- Acronym / sponsor ID
- NANOAF2 / 9637
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inclusion of the last patient
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Aix Marseille Université, LBM- Nanosecurity platform - CEA Grenoble, LR2N - Nanosecurity platform - CEA Grenoble
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 13 Dec 2020 (actual)
- Study completion
- 13 Jun 2021 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
It is well known that the nanoparticle (NP) rate is higher in large metropolitan cities but also in the airport environments owing to aircraft engine emissions. Now, this nanoparticulatepollution is a public health issue owing to its potential cardiovascular and respiratory impact on general population. Besides, an evolution of exposure in airport environments is now observed, due to the implementation of new protective equipment better adapted to nanoparticles and to the use of new fuels.
From October 2011 to June 2012, our partnership network conducted a first study on the assessment of the respiratory health of the Air France company'semployees working in the Marseillesand Paris airports (flightline and administrative employees). This study was promoted by the Montpellier CHRU, Regional University Hospital Centre (ANSM identification number 2011-A00646-35). It allowed 471 voluntary employees to be involved. They answered a lifestyle survey and underwent 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 was conducted and the elementary chemical composition analysis, as well a sieve analysis of particles present in the EACwere conducted. The data analysis from this first study (whose publications are currently being drafted) gave rise to a description of the respiratory health condition of the employees working in the vicinity of nanoparticle production sources, and to characterise exposure to nanoparticles of secondary emission originating from aircraft engine exhaust gases, as well as a description of the elementary and particulate content of the EACsin this whole population.
The analysis of the respiratory functions of the exposed subjects combined with the measurement and characterisation of nanoparticlesemitted by aircraft engines (through a metrology data analysis) and with the EACanalysis allowed the measurement of the exposure levels and the assessment of the respiratory health of the employees in an airport environment. Besides, the studied population was located on two airports in two different cities (Roissy Charles de Gaulle for Paris and Marignanefor Marseilles).
So far, no longitudinal follow-up study of airport NPsin a large size sample has been carried out, notably in a plurisdisciplinary scope. Yet only such a longitudinal follow-up analysis of the cohortwill provide a suitable impact study of the various exposure factors, taking into account their integration. Now, no large size cohortof subjects exposed to secondary emission nanoparticlesor ultrafine particles (UFP) has ever been monitored in France.
The first previously conducted study enabled us to draw up a situational respiratory health analysis on 471 employees. It also allowed us to measure nanoparticlesin their exhaled air and to evaluate their UFPexposure rate on the work station. It is now relevant to monitor the evolution of these parameters in the course of time and better assess the role of possibly confounding factors in the evolution of their respiratory health.
The EAC is collected by means of a simple device and is a non-invasive tool providing useful information on lung exposure, or even on inflammatory effects at respiratory tract level. The EACis a good proposed methodology to study exposure and effect biomarkers in professional exposure situations (Mutti 2006; Corradi 2010). Exposure biomarkers such as metals were also studied in the EACin connection with smoking (Mutti 2006) or with professional exposure to metallic particles (Goldoni 2010, Goldoni2004, Hoffmeyer2011). In a recent study, the EACwas used in order to locate nanoparticlesand oxidative stress markers (malondialdehydeand hydrogen peroxide H2O2) in volunteers exposed to cigarette smoke (Sauvain 2014). As the EACis a highly diluted aqueous medium, there is no reported matrix effect. However, one of the difficulties lies in the use of highly sensitive techniques. In the scope of our previous study, the analysis techniques were already implemented and used on the 471 collected EACsamples. The Medical Biology Laboratory of CEA in Grenoble is currently working on methodologies intended to standardise the analyses in this medium (sodium measured in parallel by ICPMS, knowing that standardisation was proposed in the literature: Dompeling 2010) and other methodologies such as total protein assaying by µBCA.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Air France Company's Employees Working | – | Other: Respiratoy health, biological investigationsObservational cohort : Air France Company's Employees Working in the Marseilles and Paris Airports having Respiratoy health, biological investigations |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects previously included in our previous study (RBC No: 2011-A00646-35; NCT03098784).
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Subject has a cons-indication (or an incompatible combination therapy) for the realization of the EFR.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratoy health, biological investigationsOnce 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. | Other | Air France Company's Employees Working |
Primary outcome
respiratory function
Time frame: 1 day (Day of inclusion (D0))
maximum expiratory volume per second (MEVS)
5 secondary outcomes
Exhaled CO measurement
Time frame: 1 day (Day of inclusion (D0))
Exhaled NO measurement
Time frame: 1 day (Day of inclusion (D0))
Exhaled air condensate
Time frame: 1 day (Day of inclusion (D0))
oxidative stress marker (8 isoprostane)
Time frame: 1 day (Day of inclusion (D0))
plasma mass spectrometry which allows the simultaneous assaying of 17 elements
Time frame: 1 day (Day of inclusion (D0))
Results and safety
The study was stopped early (reason given: Inclusion of the last patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 39585315Touri L, Tarantini A, Suehs C, Nogue E, Marie-Desvergne C, Dubosson M, Dauba A, Ravanat JL, Chamel V, Klerlein M, Artous S, Locatelli D, Jacquinot S, Chanez P, Vachier I, Molinari N. Occupational exposure to aerosols in two French airports: multi-year lung function changes. Ann Work Expo Health. 2025 Jan 8;69(1):17-33. doi: 10.1093/annweh/wxae087.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NICOLAS MOLINARI study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Air France Company's Employees Working in the Marseilles and Paris Airports (Flightline and Administrative Employees), run by University Hospital, Montpellier at 1 site in France.
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 3 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: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Inclusion of the last patient). Results are not available in the source record.
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?
respiratory function (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?
On the ClinicalTrials.gov record for NCT02872727, which also lists 1 linked publication.
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 14 May 2026.