Epidemiological Study on the Relationship Between Respiratory Health and Air Pollution From Industrial Sources (ELISABET)

ELISABET : Enquête LIttoral Souffle Air Biologie Environnement

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive; Dyslipidemias; Airway Obstruction
• Intervention / Treatment: Other: heteroevaluation scale by a nurse or doctor

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.

• Study Type: Observational
• Enrollment (Actual): 3276

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dunkirk area; Representative sample of Dunkirk and the surrounding urban area (of ~200 000inhabitants).Dunkirk area is characterize by high emission of industrial air pollutant	Other: heteroevaluation scale by a nurse or doctor
Lille area; Representative sample of Lille and the surrounding urban area (of ~1 million inhabitants, the fourth urban area in France)	Other: heteroevaluation scale by a nurse or doctor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
airway obstruction	Forced expiratory volume per second (FEV1) to forced vital capacity (FVC) ratio below 0.7. mesured by standardized spirometry Spirometry testing was performed mostly at home using Micro 6000 spirometers (Medisoft; Sorinnes, Belgium), according to the 2005 ATS/ERS guidelines. The spirometers were calibrated weekly. No bronchodilators were administered. For each participant, the spirometry test was repeated (up to seven times) until three acceptable, reproducible flow-volume loops were obtained, following the same guidelines. The greatest reproducible values of FEV1 and FVC were selected for the statistical analysis (regardless of whether these two values came from separate curves or from the same curve). All spirometry data were validated by an experienced, specialist physician.	during a the single visit scheduled (less than 3 hours in the morning)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypertension	Hypertension was defined as ongoing antihypertensive treatment, an Systolic blood pressure >=140 mmHg or a Diastolic Blood pressure >=90 mmHg	during a the single visit scheduled (less than 3 hours in the morning)
dyslipidemia	Dyslipidemia was defined as ongoing cholesterol-lowering treatment or one or more abnormal fasting blood lipid values (total cholesterol 2.4 g/L, LDLcholesterol>=1.6 g/L, HDLcholesterol <0.4 g/L or blood triglycerides >=2 g/L)	during a the single visit scheduled (less than 3 hours in the morning)
diabetes mellitus	Diabetes mellitus was defined as ongoing antidiabetes treatment (oral medication or insulin) or a fasting blood glucose (FBG) level >=1.26 g/L	during a the single visit scheduled (less than 3 hours in the morning)

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Luc Dauchet, PhD MD, CHRU Lille

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 7, 2015

Study Record Updates

• Last Update Posted (Estimate): July 7, 2015
• Last Update Submitted That Met QC Criteria: July 1, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: air pollution; epidemiological survey; representative sample
• Additional Relevant MeSH Terms: Metabolic Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Lung Diseases, Obstructive; Lipid Metabolism Disorders; Respiratory Insufficiency; Pulmonary Disease, Chronic Obstructive; Dyslipidemias; Airway Obstruction
• Other Study ID Numbers: 2009_32/1003; 2010-A00065-34 (Other Identifier: ID-RCB number, ANSM)