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临床试验/NCT02490553
NCT02490553已完成不适用

ELISABET : Enquête LIttoral Souffle Air Biologie Environnement

University Hospital, Lille0 个研究点目标入组 3,276 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,276
主要终点
airway obstruction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

airway obstruction

时间窗: 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.

次要结局

  • 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))

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

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