An Observational Study to Obtain Normal Values of Inflammatory Variables in Induced Sputum, Exhaled Breath, and Bronchial Biopsies From Healthy Smoking and Non-smoking Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- parameters for inflammation and remodelling in airway tissue
研究概览
简要总结
Smoking induces an inflammatory reaction in the airways which can ultimately result in persistent damage and the development of a Chronic Obstructive Pulmonary Disease (COPD). However, not all subjects who smoke end up with COPD. After long-term smoking, approximately 20% of subjects develop COPD. At this time, it is unclear why some subjects develop COPD, whereas others maintain a normal lung function.
In addition, smoking has important consequences in asthma. Patients with asthma who smoke have a more severe asthma and more often experience an asthma exacerbation. In addition, it has been shown that inhaled corticosteroids are less effective in smoking asthmatics.
With this research project, the researchers will investigate the effects of smoking on the airways. To this end, the researchers will compare markers of airway inflammation, lung function and symptoms between healthy smokers and non-smokers of varying age. In addition, the researchers will compare those healthy subjects with patients with asthma and COPD which are characterized in earlier studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have not smoked during the last year.
- •Have never smoked for as long as a year.
- •Have < 0.5 packyear.
排除标准
- •Persons who used inhaled or oral corticosteroids during >5 years, or within the last 5 years.
- •FEV1 <1.2 L
- •A subject is not eligible to enter and participate if he does not agree that we inform his general practicioner about participation in the study and also about any unexpected finding during the study.
- •Upper respiratory tract infection (e.g. colds), within 2 months.
- •Pregnancy, or the possibility of being pregnant (i.e. women who do not use adequate anticonception as judged by the investigator).
- •Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- •Signs or symptoms of any other concomitant disease that, in the eyes of the investigator, can interfere with the study results.
- •Known recent substance abuse (drug or alcohol).
- •Claustrophobia.
结局指标
主要结局
parameters for inflammation and remodelling in airway tissue
时间窗: The duration of the study is estimated on 2 year
次要结局
- Induced sputum, PC20 AMP, spirometrie, questionnaires, CT scan.(2 year)
研究者
Maarten van den Berge
Dr.
University Medical Center Groningen