NCT01334853已完成不适用
A Prospective Observational Study to Assess the Role of Selected Biomarkers in Subjects Requiring Daily Medium- to High-dose Inhaled Corticosteroids for Persistent Asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics.
研究概览
简要总结
The rationale for conducting this study is to explore potential clinical and peripheral biomarkers in subjects requiring daily medium to high dose inhaled corticosteroids for persistent asthma
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 through 75 at the time of screening
- •Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •History of physician-diagnosed asthma for at least 12 months prior to screening
- •Stable Medium- to high-dose ICS divided twice daily as outlined by the NHLBI Asthma Guidelines, 2007
排除标准
- •Any medical condition that, in the opinion of the investigator or medical monitor, would interfere with interpretation of subject safety or study results
- •Concurrent enrollment in another clinical study
- •Use of immunosuppressive medication within 3 months prior to screening
- •Acute upper or lower respiratory infections requiring antibiotics or antiviral medications with in 30 days prior to screening or during screning period.
- •Receipt of immunoglobulin or blood products within 30 days prior to screening or during the screening period
- •Receipt of any investigational non-biological drug therapy within 30 days or 5 half-lives prior to screening whichever is longer; or receipt of any marketed or investigational biologic within 6 months or 5 half-lives prior to screening whichever is longer
- •Pregnant, lactating, or breastfeeding woman
- •Diagnosis of lung disease other than persistent asthma
- •History of smoking ≥10 pack years or any smoking within 12 months prior to screening
- •History of active, infectious hepatitis A, B, C or human immunodeficiency virus (HIV)
结局指标
主要结局
To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics.
时间窗: 8 Days
Variables representing lung function tests, patient reported outcomes, and blood biomarkers will be evaluated singly and in various combinations.
次要结局
- To assess which markers are associated with sputum esonophils(8 Days)
- To assess which markers are associated with sputum eosinophils.(8 Days)
- To assess which markers are associated with sputum eosinophils(8 Days)
- To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses(8 Days)
研究者
研究点 (2)
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