Cell Distribution in Induced Sputum in Healthy Subjects and Patients With Asthma After Different Techniques for Sputum Induction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- cell count differences in induced sputum
研究概览
简要总结
The aim of this case-control study is the comparison of the cell distribution in induced sputum in young adults with asthma and in healthy controls.
The study consists of two visits. At both visits subjects are asked to perform a lung function test (body plethysmography) and levels of exhaled nitric oxide (eNO) are measured. At the first visit a blood sample is drawn to determine the inflammatory and allergic status of the subjects and the sputum is induced by an ultrasonic nebulizer. At the second visit another sputum sample is induced by a nozzle nebulizer. The cell distribution will be evaluated in both sputum samples.
详细描述
Objectives:
The aim of this study is the characterization of healthy children/ young adults and matched patients with asthma in terms of lung function, and the degree of the systemic and bronchial inflammation.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (qRT-PCR) and by a cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are determined from sputum or blood respectively.
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
- •between 6 and 25 years of age
- •Known bronchial asthma/no bronchial asthma(depending on the study group)
- •Ability to perform lung function tests and inhalation
排除标准
- •< 6 and > 25 years of age
- •Any acute condition with systemic or bronchial inflammation
- •any chronic condition or infection (e.g. HIV, tuberculosis, malignancy)
- •pregnancy
- •known alcohol and/ or drug abuse
- •Inability to understand the extent and scope of the study
- •Participation in another study
结局指标
主要结局
cell count differences in induced sputum
时间窗: V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
Differences in neutrophils, macrophages and lymphocytes in subjects with and without asthma
次要结局
- differences in cell count depending on the method of sputum induction(V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour))
研究者
Dr. med. Martin Rosewich
Principal Investigator
Johann Wolfgang Goethe University Hospital