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临床试验/NCT05525169
NCT05525169招募中不适用

Study of the Impact of Exposure to Outdoor and Indoor Pollutants in Patients With Asthma

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Asthma exacerbations

研究概览

简要总结

The project is to measure exposure to outdoor and indoor air pollutants in asthma patients in order to show a possible association between variation in pollutant exposure and the occurrence of exacerbations in these patients

详细描述

Asthma is a chronic airway disease affecting between 6% and 7% of the French adult population. Asthma is responsible for nearly 1000 deaths each year in France. Air pollution (indoor and outdoor) is responsible for 7 million deaths each year according to the World Health Organization (WHO) assessment published in 2018, including 65,000 in France. Studies monitoring exposure to indoor air pollutants are few in number in asthmatic patients. Very little research has been devoted to continuous monitoring of indoor air quality in homes. Our hypothesis is that variation in exposure to indoor air pollutants, in relation to outdoor air, would have an impact on the occurrence of exacerbations in asthmatic patients.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 18 years of age,
  • Patient with a confirmed diagnosis of asthma for at least 12 months as defined by the investigator,
  • Patient with at least 4 asthma exacerbations in the last year
  • Patient sleeping at least 6 nights per week in the same home

排除标准

  • Patient who is an active smoker or living with an active smoker,
  • Patient with a diagnosis of COPD, ABPA or associated pulmonary fibrosis,
  • Patient with an asthma exacerbation within 15 days prior to the inclusion visit,
  • Patient with known occupational exposure,
  • Patient living in a dwelling that does not allow the installation of sensors (inability to connect the sensor to the power supply, no location for the outdoor sensor...)
  • Patient who plans to move in the next 6 months,
  • Patient with a life expectancy of less than 6 months,
  • Patient who has someone living in their household also included in EXAP,
  • Patient who lives in an apartment and does not have a balcony or space for the outdoor sensor,
  • Pregnant or breastfeeding women,

结局指标

主要结局

Asthma exacerbations

时间窗: 36 months

The primary criterion is the association between the occurrence of exacerbations and the concentrations of the following pollutants or other environmental factors measured daily in the patients' homes by air pollution sensor inside and outside the home. * the concentration of indoor pollutants: PM1 (µg/m3), PM2.5 (µg/m3), PM10 (µg/m3), volatile organic compounds (VOC) (µg/m3) , CO2 (ppm), * the concentration of outdoor pollutants (µg/m3): PM1, PM2.5, PM10, * The ratios (indoor/outdoor air) of PM1, PM2.5 and PM10 in the home, * Temperature(°C) and relative humidity (RH) (%) in indoor and outdoor air, * Exceedances of regulatory (provided by the Environmental Code) or recommended (determined by the sensor supplier) pollutant thresholds.

次要结局

  • Daily Peak flow (l/ min)(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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