Clinical trial NCT02490553: Epidemiological Study on the Relationship Between Respiratory Health and Air Pollution From Industrial Sources
Official title: ELISABET : Enquête LIttoral Souffle Air Biologie Environnement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Obstruction
Hypertension
Diabetes Mellitus
Dyslipidemias
Pulmonary Disease, Chronic Obstructive
Keywords: air pollution
epidemiological survey
representative sample
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 3276
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The participants were selected from electoral rolls by random sampling, with stratification for gender, age and centercentre (Lille or Dunkirk). All participants were all recruited between January 2011 and November 2013. Each selected participant received a letter asking him/her to contact the coordinating team and make an appointment for data collection. In the absence of a reply, participants were contacted by telephone. Data was collected at home (occasionally during a consultation in a healthcare establishment). In all cases, a trained, registered nurse administered a detailed questionnaire and performed spirometry testing.

Brief summary: The ELISABET STUDY is across sectional Survey on a representative sample of two urban area conduct on a representative sample. The main objective of the project is to compare the prevalence of the obstructive ventilatory disorders (OVD) in the Urban Community of Dunkirk touched by the industrial pollution in relation to the one recovered in the Urban Community of Lille (CUDL) less industrialized.

Detailed description: Airflow obstruction include Pulmonary Disease, Chronic Obstruction and asthma. Identification of Airflow obstruction is through Functional Tests Lung. In the 1950s, high pollution levels were associated with increased mortality. Despite a reduction of air pollution, it has been established that pollution peaks have short-term effects on acute respiratory episodes. The Urban Community of Dunkirk (CUD) focuses many large pollutant emitters. The long term effects of industrial pollution on TVO are unknown.

The main objective of the project is to compare the prevalence of Airflow obstruction in the Urban Community of Dunkirk affected by industrial pollution compared to that found in the Urban Community of Lille (CUDL) less industrialized. Secondary objectives are: 1) To assess the relationship between air pollution from industrial and biological markers, particularly the plasma concentrations of heavy metals 2) To assess the prevalence of TVO general population in French populations 3) Establish a baseline epidemiological and biological bank.

Eligibility criteria: Inclusion Criteria:

* had lived for at least 5 years in the same city or its surrounding urban area (either Lille or Dunkirk) in the northern of France
* Agreed to participate and signed contentment

Exclusion Criteria:

* The detainees
* People under legal protection
* Individuals unable to consent

Primary outcomes:
measure: airway obstruction
timeFrame: during a the single visit scheduled (less than 3 hours in the morning)
Secondary outcomes:
measure: hypertension
timeFrame: during a the single visit scheduled (less than 3 hours in the morning)
measure: dyslipidemia
timeFrame: during a the single visit scheduled (less than 3 hours in the morning)
measure: diabetes mellitus
timeFrame: during a the single visit scheduled (less than 3 hours in the morning)
Other outcomes:
Locations:
Study officials:
affiliation: CHRU LILLE
name: Luc Dauchet, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: