Exposure to Particulate Matter on the London Underground in Healthy Subjects and Patients With Chronic Respiratory Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- The difference (London Underground vs control exposure) in post exposure pulse wave velocity in healthy vs COPD participants.
研究概览
简要总结
An average of 4.8 million journeys are made on the London Underground every day and as the 'Tube' has elevated airborne particulate matter concentrations compared to ambient air, this raises concern about the potential health impact of this environment. This study explores the health effects of particulate matter from the London Underground on patients with COPD and healthy volunteers.
Patients with COPD and healthy participants will be invited to undertake a set 90 min journey on the London Underground, and on a separate occasion (3-8 weeks apart), a 90 min journey on the London Overground (as a proxy for a clean air London area while maintaining other aspects of a train journey). A series of clinical, physiological and inflammatory data will be collected before, during and after (at different time points) each of the sessions in order to compare their response in relation to exposure and/or to disease status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for both groups:
- •Give informed consent
- •London resident
- •For participants with COPD:
- •GOLD stage 2 COPD (FEV1/FVC<70%; 50%>FEV1<80% predicted), GOLD stage 3 COPD (FEV1/FVC<70%; 30%>FEV1<50%) and GOLD stage 4 (FEV1/FVC<70%;FEV1<30%)
- •No history of ischaemic heart disease
- •For healthy volunteers:
- •No history of ischaemic heart disease.
- •Normal lung function with no evidence of airflow obstruction.
排除标准
- •for both participants with COPD and healthy volunteers:
- •Those with unstable ischaemic heart disease or COPD.
- •Current smokers and those who are ex-smokers of <12 months duration.
- •Those who work in the London Underground or are occupationally exposed to - - high levels of vehicle traffic exposure on a frequent basis.
- •Those who cannot walk for 30 mins.
- •Involvement in another research study
- •Those unable to give consent.
研究组 & 干预措施
COPD patients
As per inclusion and exclusion criteria for COPD patients
干预措施: Exposure to London Underground ambient particulate matter (Other)
COPD patients
As per inclusion and exclusion criteria for COPD patients
干预措施: Exposure to London air ambient particulate matter (Other)
Healthy volunteers
As per inclusion and exclusion criteria for healthy volunteers
干预措施: Exposure to London Underground ambient particulate matter (Other)
Healthy volunteers
As per inclusion and exclusion criteria for healthy volunteers
干预措施: Exposure to London air ambient particulate matter (Other)
结局指标
主要结局
The difference (London Underground vs control exposure) in post exposure pulse wave velocity in healthy vs COPD participants.
时间窗: -2 hours, +2 hours, +5 hours, +6 hours, +24 hours
Measurement of arterial stiffness
次要结局
- Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure(-2 hours, +24 hours)
- Other clinical responses on the London Underground vs control exposure(-2 hours, +7 hours, +24 hours)
- Other clinical responses on the London Underground vs control exposure(-2 hours, 0 hours, +45 minutes +90 minutes, +4 hours, +5 hours, +6 hours, +24 hours)
- Other clinical responses on the London Underground vs control exposure(-2 hours, 0 hours, +45 minutes, +90 minutes, +2 hours, +4 hours, +6 hours, +24 hours)
- Circulating inflammatory and oxidative responses after the exposure on the London Underground vs control exposure(-2 hours, +7 hours, +24 hours)