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临床试验/NCT02879838
NCT02879838Unknown不适用

Occupational Respiratory Allergies and Gene-environment Interactions

Central Hospital, Nancy, France12 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
12
主要终点
Classification of suspected work-related asthma in occupational asthma, work aggravated asthma, non-work-related asthma

研究概览

简要总结

The purpose is to compare clinical, functional, professional and socio-economical characteristics of patients with occupational asthma and work aggravated asthma.

Secondary purposes are:

  • to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric oxide and cytology of induced expectoration;
  • to estimate medical-social becoming of diagnosed work-related asthma after one year;
  • to establish a biobank of blood samples of individuals with work related asthma for measurement of cytokines and search for genetic polymorphisms associated with asthma.

详细描述

Participants with work related asthma or suspected work related asthma will obtain a precise diagnosis concerning severity and control of respiratory disorder and also the possible effect of professional environment on the disorder. Their medical care and medico-legal care, in case of recognition of occupational disease, could be ameliorated.

In general, this study will allow the harmonization of diagnostic care and medical, medico-professional and medico-legal management of cases of work related asthma in specialized hospitals.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient consulting for suspected work-related asthma in one of hospitals participating to the study

排除标准

  • Patient refusing to participate
  • Pregnant or breastfeeding women
  • Individual in life-threatening emergency
  • Hospitalized patient
  • Patient in a health or social institution
  • Person deprived of liberty
  • Person with total occupational disability
  • Retired person
  • Person diagnosed as non-asthmatic
  • Asthmatic person already enrolled in a clinical trial of bio-therapy to treat asthma

结局指标

主要结局

Classification of suspected work-related asthma in occupational asthma, work aggravated asthma, non-work-related asthma

时间窗: Inclusion

Interpretation of diagnostic algorithm of study

次要结局

  • Costs of different types of asthma(Inclusion and after 1 year)
  • Cytology of induced expectoration(Inclusion)
  • Nitric oxide level(Inclusion)
  • Nonspecific bronchial hyperreactivity evaluated with metacholine bronchial challenge test and/or isocapnic hyperventilation test(Inclusion)
  • Control of asthma symptoms evaluated with Asthma Control test and peak exploratory flow(Inclusion)
  • Severity of symptoms(Inclusion)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (12)

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