NCT00331058终止1 期
A Study To Validate Key Therapeutic Targets and Characterise Their Response to Corticosteroids in Multiple Asthma Phenotypes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- evaluate changes in target expression in response to a 2 week course of corticosteroids across the 4 asthma phenotypes
研究概览
简要总结
The primary goal of this study is to compare the expression of key GSK drug targets across the 4 asthma phenotypes and healthy subjects and secondarily to evaluate changes in target expression in response to a 2-week course of corticosteroids across the 4 asthma phenotypes. Each asthmatic subject in this study will undergo two bronchoscopies. Each healthy subject will undergo one bronchoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
evaluate changes in target expression in response to a 2 week course of corticosteroids across the 4 asthma phenotypes
时间窗: visits 3 through to and including visit 6
compare key drug targets across 4 asthma phenotypes and healthy subjects
时间窗: visits 3 through to and including visit 6
次要结局
- Cytospins(visits 3 through to and including visit 6)
- Histopathology on bronchial biopsies(visits 3 through to and including visit 6)
- target expression in the blood(visits 3 through to and including visit 6)
- inflammatory markers(visits 3 through to and including visit 6)
- Quality of life (QoL) and symptom scores(visits 3 through to and including visit 6)
- activation state of a signalling pathway(visits 3 through to and including visit 6)
- target protein expression(visits 3 through to and including visit 6)
- Measures of pulmonary inflammation(visits 3 through to and including visit 6)
- Assessments of lung structure(visits 3 through to and including visit 6)
- lung function(visits 3 through to and including visit 6)
- Changes in medication(visits 3 through to and including visit 6)
- new targets and biomarkers(visits 3 through to and including visit 6)
- Radiological Parameters(visits 3 through to and including visit 6)
- Pharmacogenomics from blood samples(visits 3 through to and including visit 6)
- Whole Blood TaqMan and/or transcriptomic analysis(visits 3 through to and including visit 6)
- TaqMan and/or Differential Gene Expression and Proteomics(visits 3 through to and including visit 6)
研究者
研究点 (3)
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