Controlled Human Exposure to Indoor Air, Dust and Ozone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Causes of subjective Health effects from dust, ozone and interaction with dust and ozone as air pollutants compared to exposing with placebo filtered air.
研究概览
简要总结
The aim of the study is to provide information which may help to improve the quality of the life of persons exposed to indoor environments in Danish dwellings.
The experiment will document if dust and ozone contribute to deterioration of indoor air quality and to the occurrence of symptoms and health effects.
The study is aimed at testing the hypothesis that the presence of ozone potentiate the health and comfort effects of dust exposure in the indoor environment.
Testing this hypothesis will be based on the following questions:
Does house dust and ozone in concentrations frequently encountered in Danish dwellings cause unwanted health effects either by themselves or by interaction?
If so, does the presence of ozone potentiate the expected irritative effects of dust?
The challenge of these hypotheses will be made as a controlled experiment on humans in a climate chamber under controlled exposure conditions.
This controlled human experiment should be able to substantiate the findings from the intervention studies.
Furthermore, they ideally reflect something relevant to the general public and therefore should have maximum public appeal and application possibilities.
详细描述
This study is a part of a broader research programme established by CISBO ( Centre for Indoor air and Health in Dwellings). The purpose of the centre is to increase the general knowledge and to provide information on indoor air quality and related Health effects. The study may contribute with basic information on underlying pathophysiological mechanisms involved in human responses to these pollutants and in their interactive effects. The study includes as methods and techniques to detect minor changes in biomarkers suggesting early effect of exposure. These analyses will give information at a high sensitive level about the exposure effects on biomarkers for an array of symptoms and reactions.
The study Group consitss of 24 non-smoking persons(aged 60-70). A controlled, randomized and balanced Latin square cross-over design using the participants as their own controls. The exposures are arranged in a full-scale climate chamber where the participants will be exposed for 5½ hour under controlled environmental conditions.
The exposure facility (Climate chamber):
The exposures are arranged at the controlled experimental facilities at our department which include climate chambers and exposure generators for dust and ozone. The exposure sessions will take place under controlled conditions in a 79 m3 climate chamber made of welded stainless steel optimized for experiments with gasses and particulate air pollutants. The chamber facility allows exposures with controlled ventilation, temperature and air humidity and has an efficient mixing of ventilation air with the chamber air.
All participants will attend all four diff. exposure sessions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoker
- •Normal lung function
- •No active allergic rhinitis
- •Be free from clinically significant cardiac, pulmonary, neurological and psychiatric disease as determined by medical history, physical examination and screening investigations.
- •With no clinically-significant deviation outside the normal ranges for blood presure and pulse Measurements.
- •Capable of giving informed consent
- •Be avaible to complete the study
- •Provide oral and written informed consent to participate in the study
排除标准
- •Upper respiratory tract infection within 2 weeks
- •Medical conditions likely to affect the outcome of the study in the opion of the investigator.
- •Presence of any respiratory disease
- •Infection of the upper Airways/lower Airways includingviral infections in the 14 days prior to screening and at the start of/or during the study.
结局指标
主要结局
Causes of subjective Health effects from dust, ozone and interaction with dust and ozone as air pollutants compared to exposing with placebo filtered air.
时间窗: The Health outcomes were conducted at baseline, immediately after exposure (½ + 3½ hours) and the end of exposure (5½ post exposure initiation).
To assess the subjective discomfort from dust and ozone. The subjective baseline and follow-up Health Measurements includes completing a computerbased symptom and comfort questionnaire. Three indexes were used: Index for Irritated Body perceptions (IBP) consisting of the individual symptoms eye irritation, throat irritation and nose irritation, Index for Lower Respiratory Effects (LRE) consisting of perceptions of cough, shortness of breath and tightness of breath and finally the Index for Weak Inflammatory Response (WIR) consisting of eye irritation, dry eyes, watering eyes, throat irritaion, nose irritaion and itching skin.
次要结局
- To assess changes in Forced Expiratory Volume (FEV1)(On each study day : baseline, 30 min., 3½hour, 5½ post-exposure and in 3 hour intervals for 24 hours.)
- To assess changes in the intranasal volume measured by acoustic rhinometry (AR)(During the study day Measurements for AR will be performed at baseline, immediately following exposure and at the end of the study day (at 5½ hours from baseline))
- To assess changes in the epithelial plasticity with Endopat measures.(The EndoPat was conducted in the end of exposure (5½ post exposure initiation).)
- To assess changes in blood biomarkers compared with exposing with placebo filtered air.(The blood samples were conducted at baseline, in the end of exposure (5½ post exposure initiation) and follow-up (24 hours))
- To assess changes in concentrations of cytokines in nasal lavage fluid.(The lavage samples were conducted at the pre-exposure and in the end of exposure (5½ post exposure initiation).)