Cell Distribution in Induced Sputum in Patients With Asthma
Cell Distribution in Induced Sputum in Healthy Subjects and Patients With Asthma After Different Techniques for Sputum Induction
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.
研究概览
详细说明
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)
V1 (day 0 - duration 1 hour):
- Measurement of exhaled nitric oxide (eNO)
- Lung function testing with and body plethysmography
- Blood test: blood count, CRP, RAST, serum inflammatory mediators, markers of the non-specific pulmonary defense system
- Induced sputum attained by an ultrasonic-nebulizer for inflammatory mediators and microbiological investigations
V2 (day 14-28 - duration 1 hour):
- Measurement of nitric oxide in expired air (eNO)
- Lung function testing with spirometry and body plethysmography
- Induced sputum attained by a nozzle-nebulizer for inflammatory mediators and microbiological investigations
Study population:
Children, adolescents and young people (6 - 25 years of age). Both the patients and the healthy subjects are recruited from the outpatient clinic of Pediatric Allergy and Pulmonology.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Hessen
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Frankfurt am Main、Hessen、德国、60596
- Children's Hospital, Goethe-University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- < 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Patients with Asthma
Affected patients -20 Patients suffering from asthma with an eNO over 30 bbp |
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Healthy Subjects
Non-affected patients -20 matched controls not suffering from asthma |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
cell count differences in induced sputum
大体时间：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
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V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
differences in cell count depending on the method of sputum induction
大体时间：V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
|
At V1 an ultrasonic nebulizer is used for sputum induction.
At V2 a breath controlled nozzle nebulizer is used for sputum induction.
These different techniques might lead to different cell counts in included subjects.
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V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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