NCT01268072终止不适用
A Prospective Observational Study to Evaluate Biomarkers in Acute Exacerbations in Chronic Obstructive Pulmonary Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Identify biomarkers for evaluation of efficacy in subjects presenting with AECOPD
研究概览
简要总结
The primary objective of this study is to identify biomarkers that can be used for evaluation of efficacy in subjects presenting with AECOPD
详细描述
Identify biomarkers that can be used for evaluation of efficacy in subjects presenting with AECOPD by evaluating longitudinal changes and the interrelationship of blood and sputum biomarkers with physiological endpoints and symptom measures in stable subjects with COPD likely to experience a future AECOPD, and in subjects during severe AECOPD.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years at the time of screening
- •Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- •Cohort 1 only: A primary diagnosis of clinically stable physician-diagnosed COPD upon entry into the study meeting one of the following criteria:
- •Subjects who have experienced a severe AECOPD requiring inpatient hospitalization in the previous 12 months
- •Subject who had one severe AECOPD requiring ED visits in the past 9 months
- •Subjects who are currently on LTOT.
- •Cohort 1 only: Stable COPD for 4 weeks prior to screening, as defined by no change in ICS therapy and no use of oral corticosteroids or antibiotics for a respiratory tract infection.
- •Cohort 1 only: Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) < 0.70 or lower limits of normal (LLN).
- •Cohort 1 only: FEV1 < 60% predicted normal value.
- •Cohort 2 only: A primary diagnosis of physician-diagnosed AECOPD requiring admission to the hospital.
- •Current smoker or ex-smoker with a tobacco history of ≥ 10 pack-years (one pack year = 20 cigarettes smoked per day for 1 year).
- •Ability and willingness to complete the appropriate follow-up period of time as required by the protocol.
- •Able to read and write and use the electronic devices (English or Spanish version).
排除标准
- •Participation (defined as administration of at least one dose of investigational product) in another clinical study, the last follow-up visit of which is within 12 weeks (for a small molecule drug) and (6 months for a large molecule drug) of entry into this study.
- •Any condition that, in the opinion of the investigator would interfere with interpretation of subject safety or study results.
- •Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- •The presence of another chronic pulmonary or systemic disease, which in the opinion of the investigator or medical monitor might affect the analysis of the data (eg, idiopathic pulmonary fibrosis, sarcoidosis, active cancer or autoimmune disease).
- •History of immunodeficiency.
- •Current alcohol or drug abuse or a history of unsuccessfully treated alcohol or drug abuse within the past year.
- •Cohort 2 only: Diagnosis of an acute disease/condition (eg, congestive heart failure, acute myocardial infarction, pneumonia, or pulmonary embolus) that is the primary reason for the subject's hospitalization.
结局指标
主要结局
Identify biomarkers for evaluation of efficacy in subjects presenting with AECOPD
时间窗: 12 months
Investigate changes in physiological measures, symptoms, and blood, urine and sputum biomarkers in subjects with stable COPD during AECOPD, and as subjects return to clinical stability.
次要结局
- Hospitalization, treatment and discharge of COPD subjects(12 months)
研究者
研究点 (1)
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