Exposure to Secondhand Smoke in Exempted Areas/Outside Areas and Acute Health Effects in Patients With Chronic Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Respiratory Rate
研究概览
简要总结
Within the TackSHS project (H2020 project grant agreement No 681040), we will conduct a clinical research study, aiming at: i) to measure respiratory health effects when exposed to secondhand smoke (SHS) in patients with asthma and Chronic Obstructive Pulmonary Disease (COPD); ii) to investigate exposure levels to SHS in smoking areas provided by bars, casinos, bingo halls, etc. The study will involve 60 patients (volunteers) in three European countries: Czech Republic, Ireland, and Spain, recruiting 20 patients in each participating country (10 COPD and 10 asthma patients).
详细描述
The current study is a part of the TackSHS project and will be conducted in three selected European countries, coordinated by Prof Luke Clancy, Director General of TobaccoFree Research Institute (Dublin, Ireland).
Background: Respiratory disease causes an important worldwide health burden. It was estimated that in 2020, of 68 million deaths worldwide, 11.9 million will be caused by lung diseases, 4.7 by COPD, 2.5 by pneumonia, 2.4 by TB and 2.3 million by lung cancer. Over the past two decades, scientific evidence has accumulated linking secondhand tobacco smoke (SHS) exposure to adverse health outcomes, including respiratory outcomes in children and adults, acute cardiovascular effects, and lung cancer. However, there is scarce knowledge about health effects of SHS on respiratory disease patients. TackSHS is a new research project funded by the European Commission (EC) within the Horizon 2020 programme (Grant Agreement: 681040). Within the TackSHS Project, WorkPackage 5 is aimed to broaden knowledge and improve understanding of (immediate) effects of SHS to respiratory health.
The study objectives are to:
- measure respiratory health effects when exposed to SHS in: patients with asthma and COPD
- investigate exposure levels to Second Hand Smoke (SHS) in smoking areas provided by bars, casinos, bingo halls, etc.
Study Design Population: The study population will consist of 30 Asthmatic and 30 COPD subjects to be recruited through the European Lung Foundation (ELF) in three EU countries (20 subjects in each country), leading to a total sample of 60 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Dr Diagnosed COPD patients
- •Current or ex-smokers
- •Fully ambulatory
- •Frequent visits to smoking areas*
- •Between 50 and 70 years old
- •Confirmed Dr Diagnosed Asthmatic patients
- •Fully ambulatory
- •Frequent visits to smoking areas
- •Over 18 years old
排除标准
- •Under 18 years old
- •On oxygen therapy
- •Never smokers in COPD patient group
- •Undergoing treatment for acute exacerbations
- •Pregnant women
- •Irish law has defined an outdoor smoking area as: a place or premises, or part of a place or premises that, is wholly uncovered by any roof, fixed or mobile. An out door place or premises that is covered by a roof, so long as not more than 50% of the perimeter (outside) is covered by a wall, windows, gate or similar.
结局指标
主要结局
Respiratory Rate
时间窗: 24hours to include during non exposure and exposure to SHS
Respiratory rate during non exposure and exposure to secondhand smoke: change from baseline respiratory symptoms
次要结局
- Medication Usage(24 hours)
- Secondhand Smoke Exposure Levels(1) At homes - 24 hours, during the study period; 2) in outside smoking areas - 15-60 minutes during the intervention)