NCT00655954已完成不适用
Osteoprotegerin (OPG) in Induced Sputum as a Novel Biomarker for COPD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Sputum OPG
研究概览
简要总结
Evaluation of OPG level as disease markers has also been reported. It has been showed that patients with coronary artery disease had higher serum OPG levels than healthy volunteers. Moreover, serum OPG levels correlate with the number of stenotic coronary arteries
详细描述
Osteoprotegerin (OPG) is a secreted glycoprotein containing 401 amino acids. It is a member of the tumour necrosis factor (TNF) receptor superfamily. It was firstly discovered as a protein regulating bone metabolism, inhibiting osteoclastogenesis, consequently, inhibiting bone resorption OPG is detected in lung using Northern blot analysis. It is likely that OPG would contribute to the pathogenesis of COPD and could be an effective disease marker of the disease
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smokers
- •Age <35 years (younger group)
- •Aged matched to COPD patients (older group)
- •Normal spirometry
- •Subjects are able to give informed consent
- •Healthy smokers
- •Age <35 years (younger group)
- •Aged matched to COPD patients (older group)
- •Normal spirometry
- •Subjects are able to give informed consent Stable COPD patients: Stage I-IV according to the GOLD guidelines (3), (9)
- •Current and/or ex-smokers with no less than 10 pack-year smoking history
- •The subjects are able to give informed consent COPD patients with acute exacerbation: Stage I-IV according to the GOLD guidelines (3), (9)
- •Exacerbation of COPD defined as "an event in the natural course of the disease characterised by a change in the patient's baseline dyspnoea, cough and/or sputum beyond day to day variability sufficient to warrant a change in management" (9)
- •Current and/or ex-smokers with no less than 10 pack-year smoking history
- •The subjects are able to give informed consent Asthma patients
- •Patients diagnosed with asthma
- •The subjects are able to give informed consent Bronchiectasis patients
- •Patients with CT-confirmed bronchiectasis
- •The subjects are able to give informed consent Cystic fibrosis patients
- •Patients diagnosed with cystic fibrosis
- •The subjects are able to give informed consent
排除标准
- •Healthy non-smokers and smokers
- •Upper respiratory infection within the last 4 weeks.
- •Subjects who have received research medication within the previous one month.
- •Subjects unable to give informed consent.
- •Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study Stable COPD patients
- •Patients who have had an exacerbation which required treatment with oral steroids during the last 2 months prior to the visit
- •Upper respiratory infection within the last 4 weeks
- •Subjects who have received research medication within the previous one month
- •Subjects unable to give informed consent
- •Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study COPD patients with acute exacerbation
- •Subjects who have received research medication within the previous one month
- •Subjects unable to give informed consent
- •Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study Asthma
- •Upper respiratory infection within the last 4 weeks
- •Subjects who have received research medication within the previous one month
- •Subjects unable to give informed consent.
- •Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- •Bronchiectasis and cystic fibrosis
- •Subjects who have received research medication within the previous one month.
- •Subjects unable to give informed consent.
- •Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
结局指标
主要结局
Sputum OPG
时间窗: 1 hour
Sputum OPG as assessed by ELISA at baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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