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临床试验/NCT02073708
NCT02073708进行中(未招募)不适用

A Population-based Investigation of Asthma in the Telemark Region of Norway

Sykehuset Telemark1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
2,000
试验地点
1
主要终点
The occurence of asthma and the association to specific occupational and environmental exposures and comorbidity

研究概览

简要总结

Respiratory conditions impose an enormous burden on the individual and the society. According to the WHO World Health Report 2000, the top five respiratory diseases - including asthma and COPD - account for 17% of all deaths and 13% of all Disability-Adjusted Life Years (DALYs). Obstructive lung diseases are among the most common chronic diseases in working-aged populations affecting ~40 million individuals in Europe. The greatest economic burden of respiratory diseases on health services and lost production in the EU is due to COPD and asthma, at about €20 billion each for healthcare and €25 billion and €15 billion, respectively, for lost production.

For Norway, there are no estimates of asthma prevalence for the country as a whole, but 80/1000 women and 55/1000 men used asthma medication in 2013 according to the national prescription register. Estimated annual deaths in Norway due to COPD were 4070 in 2015, which is 30% higher than for lung cancer. Unfortunately, a substantial proportion of patients are still difficult to treat. This underlines the need for better primary prevention and more knowledge regarding causes and exacerbating factors.

Several risk factors for chronic respiratory diseases are identified, most important tobacco smoke, closely followed by air pollution and occupational exposure. However, according to recent reviews there is a lack of understanding regarding environmental risk factors and mechanisms of how these affect respiratory health, the importance of biological markers and comorbidity, and of socioeconomic risk factors. Moreover, there is a need for assessment of interactions between risk factors and between the individual and the environment.

Telemark has a high proportion of craft- and industrial workers providing exposure contrasts. Furthermore, the use of medication against respiratory diseases and the rate of sick leave are higher in Telemark than elsewhere in Norway. Moreover, the county has a high rate of disability. There are previous studies from other parts of Norway, which have estimated the occurrence of respiratory diseases and provided valuable knowledge regarding some risk factors. However, these studies use crude measures of self-reported exposure and do not provide sufficient information on how to target intervention and implement effective prevention. In contrast to the Telemark study, these studies have not included register data or advanced modelling of environmental exposure.

详细描述

Hypotheses and choice of methods:

Primary objective:

To identify preventive and health promoting measures for obstructive respiratory disease in a 5-year follow up of adults from the general population in Telemark.

Secondary objectives:

  • Identify occupational risk factors for obstructive respiratory disease
  • Assess interactions between risk factors and the individual
  • Transfer relevant knowledge and advice regarding preventive and health promoting measures to individuals, health care professionals and authorities.

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
16 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Physician diagnosed asthma
  • Controls without physician-diagnosed asthma

排除标准

  • inability to fill-inn the questionnaire

结局指标

主要结局

The occurence of asthma and the association to specific occupational and environmental exposures and comorbidity

时间窗: Five years

Incidence and associations

次要结局

  • Risk factors for the occurence of asthma symptoms in subjects with asthma symptoms but no asthma diagnosis(Five years)
  • Differences in lung function, FeNO and inflammatory markers in blood in asthma patients and the association of these changes to specific occupational and environmental exposures.(Five years)

研究者

发起方
Sykehuset Telemark
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anne Kristin M. Fell

MD, PhD

Sykehuset Telemark

研究点 (1)

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