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临床试验/NCT02802891
NCT02802891已完成不适用

Projeto JOIN - o ar Como Meio de prevenção e a diagnóstico da Asma e Alergia

Universidade do Porto1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年12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
64
试验地点
1
主要终点
Volatile organic compounds in the exhaled breath condensate

研究概览

简要总结

The JOIN project combines the health and indoor environment research areas to contribute in the development and validation of a new asthma diagnosis method through exhaled VOC analysis. This method is more sensitive, more specific, and completely non-invasive. Moreover, the JOIN project will assess the impact of exposure to the indoor environment, namely endocrine disruptors, on asthma and allergy development in children.

详细描述

Objectives:

The JOIN project combines the health and indoor environment research areas to contribute in the development and validation of a new asthma diagnosis method through exhaled VOC analysis. This method is more sensitive, more specific, and completely non-invasive. Moreover, the JOIN project will assess the impact of exposure to the indoor environment, namely endocrine disruptors, on asthma and allergy development in children. The specific objectives of the project are:

  1. Classify children with asthma and healthy controls using exhaled VOC profiles;
  2. Classify asthma phenotypes using exhaled VOCprofiles;
  3. Evaluate the influence of prolonged exposure to exogenous VOCs on the exhaled breath samples;
  4. Characterize indoor exposure by measuring the concentrations of a set of chemicals identified as EDCs in indoor air and dust at homes;
  5. Evaluate the association between exposure to EDCs indoors and children's health outcomes focused on asthma/allergies and also with the exacerbation of allergies and respiratory symptoms in those who are already sensitized;
  6. Investigate which building materials and consumer products might be contributing most to children's exposure;
  7. Assess the association between EDCs indoor exposure and lung function, airway inflammation and responsiveness, and exhaled and urine biomarkers of disease.

The completion of this project may contribute to the validation of a new asthma diagnostic method on its way to be introduced in a real clinical context.

The indoor air quality auditing will permit a better understanding of the exposure process to endocrine disruptors and health effects, mainly in children. The project will also evaluate and compare EDCs in indoor air and in children, as a result from exposure.

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
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals (6 to 18 years old) with skin prick tests and spirometry with bronchodilation results.

排除标准

  • Individuals with chronic diseases (other than asthma and atopy)
  • Planning to change home address in the next 4 months
  • Low volume of EBC
  • Refused to participate despite signing written consent

结局指标

主要结局

Volatile organic compounds in the exhaled breath condensate

时间窗: 4 to 8 months after recruitment

Volatile organic compounds, released from EBC through heating, will be measured by an electronic nose system

次要结局

  • ISAAC-based questionnaire(4 to 8 months after recruitment)
  • 24h food questionnaire(4 to 8 months after recruitment)
  • Endocrine disruptors in the house dust(4 to 8 months after recruitment)
  • Endocrine disruptors in the urine(4 to 8 months after recruitment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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