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Clinical Trials/NCT02490553
NCT02490553CompletedNot Applicable

ELISABET : Enquête LIttoral Souffle Air Biologie Environnement

University Hospital, Lille0 sites3,276 target enrollmentStarted: January 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
3,276
Primary Endpoint
airway obstruction

Study Overview

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.

Study Design

Study Type
Observational
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
40 Years to 64 Years (Adult)
Sex
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

Exclusion Criteria

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

Outcomes

Primary Outcomes

airway obstruction

Time Frame: 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 Outcomes

  • hypertension(during a the single visit scheduled (less than 3 hours in the morning))
  • dyslipidemia(during a the single visit scheduled (less than 3 hours in the morning))
  • diabetes mellitus(during a the single visit scheduled (less than 3 hours in the morning))

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

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