The Effects of Traffic-Related Air Pollution on Smokers at Risk for Developing COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Cytokine pattern
研究概览
简要总结
The investigators are investigating the effects of traffic-related diesel exhaust on lung function and the immune system in those at risk for COPD. The individual will be exposed to either filtered air (FA) or carefully controlled levels of diesel exhaust (DE) in our exposure chamber. Post exposure the individual will complete a steady state exercise test. 24h later, a procedure called bronchoscopy (whereby a thin, flexible tube is placed down the throat and into the lungs) will be used so that samples can be collected from the lungs. After 1 month the entire procedure will be repeated with the alternative exposure.
详细描述
- Purpose:
To study the effects of traffic related diesel exhaust on people at risk for developing COPD. 2. Hypotheses:
Hypothesis 1: An increase in proteins, in the exposed lung and blood, that are associated with the pathophysiology of COPD.
Hypothesis 2: Air trapping, dyspnea, and impaired exercise tolerance. Such increases will be more pronounced in those with COPD than in control subjects. 3. Justification:
The use of diesel engines is increasing because they are more fuel-efficient than gasoline engines. However, diesel engines produce different emissions than gasoline engines. Diesel exhaust is emitted from the tailpipe of both "on-road" diesel engine vehicles (diesel cars, buses and trucks) and "non-road" diesel engines (locomotives, marine vessels and some construction equipment). Diesel exhaust consists of both gaseous and particulate air pollutants. People with COPD may be sensitive to air pollution; we would like to know how diesel exhaust (DE) can affects the respiratory and immune systems. We are not expecting that responses will be noticeable to the participant; we are expecting that any responses that may occur will only be detectable through careful examination of cells and tissues (e.g., bronchoalveolar lavage (fluid from lungs), blood). Understanding these subtle changes will help us prevent health problems associated with air pollution in the future. 4. Objectives To provide biological plausibility and deepen mechanistic understanding of the emerging epidemiology suggesting a strong role for air pollution in COPD. 5. Research Methods:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 40-75 years of age
- •Free of cardiovascular disease
- •Free of insulin-dependent diabetes
- •Study participants must agree to adhere to the following medication intake protocol 24 hours prior to study visits:
- •participants will be asked to withhold:
- •short-acting beta2-agonists (SABAs) for 4 hours prior to testing
- •long-acting beta2-agonists (LABAs) for 12 hours prior to testing if taken in an individual inhaler (different inhaler from inhaled corticosteroid inhaler)
- •LABAs and ICS for 24hrs, if those two medication groups are combined in one inhaler
- •ICS (if taken alone as a mono-therapy, or if taken with either a LABA or SABA, but in two separate inhaler), for 24 hrs.
- •Overall, we are looking for 15 healthy controls without a history of smoking; 20 individuals with a history of smoking, but who have been non-smokers for at least 6 months prior to study participation; and 15 mild-moderate COPD patients (GOLD I and GOLD II).
排除标准
- •Not between the ages of 40-65 years.
- •Are pregnant, breast-feeding, or planning to get pregnant in the following 12 months.
- •Are currently using inhaled corticosteroids.
- •Are allergic to salbutamol, lidocaine, fentanyl or midazolam.
- •Are currently participating in another study that involves taking medications.
- •Have unstable COPD symptoms.
- •Have clinically significant comorbidities (i.e., coronary artery disease).
- •Have a history/clinical evidence of asthma.
- •Have contraindications to exercise testing.
- •Have a body mass index <18.
- •Regularly use of antihistamines, non-steroidal anti-inflammatories, anticoagulants, acetylsalicylic acid (ASA) or decongestants.
结局指标
主要结局
Cytokine pattern
时间窗: 24 hours
BAL, BW, and blood cytokines will be assessed at 24h using immunoassays
次要结局
- Cell culture(24 hours)
- Cardiopulmonary function(1.5 hours)
- Gene expression(24 hours)
研究者
Christopher Carlsten
Principal Investigator
University of British Columbia