Protein Biomarker Discovery and Validation in COPD And Asthma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Exhaled Breath Condensate Protein Concentration
研究概览
简要总结
The purpose of the study is to better understand proteomics of asthma and COPD, and response to therapy. There are two Phases to this study broken into two arms. In Phase I, we propose is to use discovery proteomics and techniques to identify protein expression signatures. Subjects who complete Phase I are eligible, but not required, to enroll in Phase II. In Phase II, we propose to establish and validate the predictive value of protein signatures for treatment responses using inhaled corticosteroids.
详细描述
There are two Phases to this study broken into two arms. In Phase I, our propose to use discovery proteomics and high throughput techniques to identify protein expression signatures. The total planned size of Phase I is 100 patients. Patients will be divided into two arms based on disease status (COPD or asthma). Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study. No active smoking defined as never smoking or having stopped smoking for 5 years or greater.
In the Phase II, we aim to establish and validate the predictive value of proteomic signatures for therapeutic responses using inhaled corticosteroids. For Phase II, subjects who completed Phase I are eligible, but not required to participate in Phase II.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria for Asthma
- •History consistent with asthma: episodic wheezing, shortness of breath, or cough
- •Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age >18yrs
- •FEV1 >40% predicted
- •Never smoker, current smoker, or quit smoking ≥5 years ago Criteria for COPD
- •History consistent with COPD: dyspnea with exertion, productive cough, progressive course
- •Smoking history of at least 20 pack years
- •Current smoker or quit smoking ≥5 years ago
- •Age >18yrs
- •FEV1: Forced Vital Capacity (FVC) ratio < 0.70 following 2 puffs of albuterol
- •FEV1 greater than 50% predicted
排除标准
- •Exclusion for Asthma EXCLUSION
- •Other respiratory illness other than asthma
- •Chronic infectious process
- •Significant other medical illness
- •Inability to consent
- •Pregnancy Exclusion for COPD EXCLUSION
- •Other respiratory illness other than COPD
- •Chronic infectious process
- •Significant other medical illness
- •Inability to consent
- •Pregnancy
结局指标
主要结局
Exhaled Breath Condensate Protein Concentration
时间窗: 1 year through study completion
Protein concentrations were below the limit of detectability and are not scientifically robust.
次要结局
未报告次要终点