Study of the Impact of Exposure to Outdoor and Indoor Pollutants in Patients With Asthma (EXAP)
2022年11月28日 更新者：Nantes University Hospital
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
研究概览
地位
招聘中
条件
详细说明
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.
研究类型
观察性的
注册 (预期的)
30
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：François-Xavier Blanc, PU-PH
- 电话号码：02 40 16 53 33
- 邮箱：xavier.blanc@chu-nantes.fr
研究联系人备份
- 姓名：Megguy Bernard
- 邮箱：megguy.bernard@chu-nantes.fr
学习地点
-
-
-
Nantes、法国、44093
- 招聘中
- CHU de Nantes
-
接触：
- François-Xavier Blanc, PU-PH
- 电话号码：02 40 16 53 33
- 邮箱：xavier.blanc@chu-nantes.fr
-
接触：
- Megguy Bernard
- 邮箱：megguy.bernard@chu-nantes.fr
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 99年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The study population will consist of adult men and women recruited from the active file of asthma patients followed at the Nantes University Hospital, the Saint Nazaire Hospital, the Châteaubriant Nozay Pouancé Hospital and the Erdre et Loire Hospital.
Regardless of the type of asthma, patients will be potentially included if they have a minimum of 4 exacerbations during the year preceding inclusion in the EXAP project>.
Participation in other non-interventional research is allowed during the study unless this research increases the number of exacerbations.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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,
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Asthma exacerbations
大体时间：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.
|
36 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Daily Peak flow (l/ min)
大体时间：36 months
|
The secondary criterion is the the temporal association between the daily Peak flow and the concentrations of the same pollutants or other environmental factors listed in the primary criterion. Subgroup analyses : groups of patients will be created according to the characteristics of their habitat (heating mode, ventilation, rural or urban area...). Both primary and secondary outcomes will be studied in these subgroups. |
36 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：François-Xavier Blanc, PU-PH、CHU de Nantes
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年11月15日
初级完成 (预期的)
2025年9月15日
研究完成 (预期的)
2025年9月15日
研究注册日期
首次提交
2022年7月7日
首先提交符合 QC 标准的
2022年8月30日
首次发布 (实际的)
2022年9月1日
研究记录更新
最后更新发布 (实际的)
2022年12月1日
上次提交的符合 QC 标准的更新
2022年11月28日
最后验证
2022年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.