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

Hypertension Clinical Trial

— ELISABET  

Official title:

ELISABET : Enquête LIttoral Souffle Air Biologie Environnement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490553
• Other study ID #: 2009_32/1003
• Secondary ID: 2010-A00065-34
• Status: Completed
• Phase: N/A
• First received: June 25, 2015
• Last updated: July 1, 2015
• Start date: January 2011
• Est. completion date: February 2014

Study information

• Verified date: July 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3276
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 64 Years

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Airway Obstruction
• Chronic Disease
• Diabetes Mellitus
• Dyslipidemias
• Hypertension
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• heteroevaluation scale by a nurse or doctor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No