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临床试验/NCT02540408
NCT02540408已完成不适用

COPD in Dairy Farmers: Screening, Characterization and Constitution of a Cohort. The BALISTIC Study

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
prevalence of COPD in dairy farmers and in unexposed subjects

研究概览

简要总结

A pilot study from the investigators group suggests that the prevalence of chronic obstructive pulmonary disease (COPD) among dairy farmers is higher than in the general population. Most characteristics of COPD in dairy farmers (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) are largely unknown. Although immunization against organic dusts is suspected, the pathophysiology of COPD in dairy farmers is also unknown.

This study therefore aims at (i) comparing the prevalence of COPD in dairy farmers and in subjects without any occupational exposure (control arm) through a vast COPD detection program in the Franche-Comté region; (ii) comparing several characteristics (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) between dairy farmers with COPD and patients with COPD without any occupational exposure; (iv) identifying etiological factors of COPD in dairy farmers (comparison of exposure and specific immunoglobulin E between dairy farmers with COPD and dairy farmers with normal pulmonary function tests); and (v) constituting a cohort of COPD patients and control subjects for further longitudinal studies.

Data from selected patients (either current or former smokers) with mild COPD and from matched controls will also be analyzed in an ancillary study which objectives are to compare exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls.

详细描述

2000 dairy workers and 2000 subjects without any occupational exposure, all aged 40 to 74 years, will take part to a COPD screening program (spirometry and bronchodilation test) between September 2011 and October 2014.

Subjects with COPD and healthy matched controls will attend a second visit. If needed, COPD subjects will be asked to stop any respiratory related medication such as short and long acting bronchodilators 72 hours prior to the visit. All subjects will complete several questionnaires (quality of life, respiratory symptoms, smoking habits,...). A complete medical history will be collected, and a blood sample will be taken. Subjects thereafter will complete arterial stiffness measurement, exhaled nitric oxide and pulmonary function testing pre- and 30-min post-bronchodilator. A symptom-limited incremental cycle exercise test will be performed on the same day, at least 6 hours after the bronchodilator test and at least 4 hours after the meal.

Exposure to organic dusts will be quantified through analyze of electrostatic wipes left at subjects' homes for 10 weeks.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subject aged 40-74 years
  • either dairy farmer or unexposed to any occupational risk factor for COPD

排除标准

  • COPD in GOLD stage 4
  • pregnancy
  • treatment with systemic corticosteroids
  • established diagnosis of asthma
  • established diagnosis of bronchiectasis
  • established diagnosis of allergic alveolitis

结局指标

主要结局

prevalence of COPD in dairy farmers and in unexposed subjects

时间窗: 3-year

次要结局

  • comparison of lung function between dairy farmers with COPD and unexposed COPD(4-year)
  • comparison of bronchial exhaled nitric oxide between dairy farmers with COPD and unexposed COPD(4-year)
  • comparison of smoking habits between dairy farmers with COPD and unexposed COPD(4-year)
  • comparison of dyspnoea between dairy farmers with COPD and unexposed COPD(4-year)
  • comparison of systemic inflammation between dairy farmers with COPD and unexposed COPD(4-year)
  • comparison of arterial stiffness between dairy farmers with COPD and unexposed COPD(4-year)
  • comparison of exposure to organic dusts between dairy farmers with and without COPD(3-year)
  • comparison of immunization to organic dusts between dairy farmers with and without COPD(3-year)
  • comparison of exercise capacity between dairy farmers with COPD and unexposed COPD(4-year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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