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

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT02490553

Collaborator

(none)

3,276

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Airway Obstruction Hypertension Diabetes Mellitus Dyslipidemias Pulmonary Disease, Chronic Obstructive	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 Design

Study Type:

Observational

Actual Enrollment :

3276 participants

Time Perspective:

Cross-Sectional

Official Title:

ELISABET : Enquête LIttoral Souffle Air Biologie Environnement

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

airway obstruction [during a the single visit scheduled (less than 3 hours in the morning)]
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.

Secondary Outcome Measures

hypertension [during a the single visit scheduled (less than 3 hours in the morning)]
Hypertension was defined as ongoing antihypertensive treatment, an Systolic blood pressure >=140 mmHg or a Diastolic Blood pressure >=90 mmHg
dyslipidemia [during a the single visit scheduled (less than 3 hours in the morning)]
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)
diabetes mellitus [during a the single visit scheduled (less than 3 hours in the morning)]
Diabetes mellitus was defined as ongoing antidiabetes treatment (oral medication or insulin) or a fasting blood glucose (FBG) level >=1.26 g/L

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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