Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02872727 |
| Other study ID # |
9637 |
| Secondary ID |
2015-A01771-48 |
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 13, 2017 |
| Est. completion date |
June 13, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
University Hospital, Montpellier |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. This will enable us to assess the
possible link between exposure and respiratory function evolution in the employees
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
