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中国广州慢性阻塞性肺疾病急性加重风险因素和分型的前瞻性队列研究
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注册号:

Registration number:

ChiCTR2000034586 

最近更新日期:

Date of Last Refreshed on:

2020-07-11 

注册时间:

Date of Registration:

2020-07-11 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

中国广州慢性阻塞性肺疾病急性加重风险因素和分型的前瞻性队列研究 

Public title:

Study on risk factors and phenotypes of acute exacerbations of chronic obstructive pulmonary disease in Guangzhou, China: A prospective cohort study 

注册题目简写:

广州COPD急性加重研究 

English Acronym:

Study on AECOPD in Guangzhou 

研究课题的正式科学名称:

在中国广州进行的一项关于季节变化因素、致病因素、相关生物标记物和疾病加重对有慢性阻塞性肺疾病( COPD )风险的和有轻度至重度COPD的受试者影响的为期2年的开放性,纵向研究 

Scientific title:

An Open, Longitudinal, 2 Year Study in Guangzhou, China to Investigate the Seasonal Variation, Causative Factors, Associated Biomarkers and the Impact of Exacerbations in Subjects at Risk for Chronic Obstructive Pulmonary Disease 

研究课题代号(代码):

Study subject ID:

D6256M00020 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

周玉民 

研究负责人:

陈荣昌 

Applicant:

Yumin Zhou 

Study leader:

Rongchang Chen 

申请注册联系人电话:

Applicant telephone:

+86 13826190798 

研究负责人电话:

Study leader's telephone:

+86 13902273260 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

zhoyumin410@126.com 

研究负责人电子邮件:

Study leader's E-mail:

nanshan@vip.163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

广州市沿江西路151号 

研究负责人通讯地址:

广州市沿江西路151号 

Applicant address:

151 Yanjiang Road West, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

151 Yanjiang Road West, Yuexiu District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

广州呼吸疾病研究所 

Applicant's institution:

Guangzhou Institute of Respiratory Disease 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

(2009)医审第(3)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

广州医学院第一附属医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2009-03-10 

伦理委员会联系人:

广州医学院第一附属医院医学伦理委员会 

Contact Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University 

伦理委员会联系地址:

中国广东广州市沿江西路151号 

Contact Address of the ethic committee:

151 Yanjiang Road West, Yuexiu District, Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

广州呼吸疾病研究所 

Primary sponsor:

Guangzhou Institute of Respiratory Disease 

研究实施负责(组长)单位地址:

广州市沿江西路151号 

Primary sponsor's address:

151 Yanjiang Road West, Yuexiu District, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广州呼吸疾病研究所

具体地址:

广州市沿江西路151号

Institution
hospital:

Guangzhou Institute of Respiratory Disease

Address:

151 Yanjiang Road West, Yuexiu District, Guangzhou

经费或物资来源:

阿斯利康 

Source(s) of funding:

AstraZeneca 

研究疾病:

慢性阻塞性肺疾病 

Target disease:

COPD 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

主要目的:评估疾病严重程度(按GOLD分级)的影响,评估触发因素(吸烟、污染和/或病毒感染)和季节变化对中国广州患者COPD急性加重发病率的影响。评估包括采用适当的统计模型来建立这些影响因素的模型,对加重(频率)、持续时间以及加重的严重程度进行评估。 次要目的是:通过肺功能、患者报告结果、健康经济学指标、功能表现指标和CT,研究环境因素(细菌和病毒、污染、吸烟)和急性加重对COPD的疾病进程的影响;研究生化及影像学标志物等与COPD急性加重、疾病进展和疾病严重程度之间的关系;研究COPD患者和对照组之间在骨骼肌的病理和表型之间的不同。急性加重开始时和缓解后对肌肉的影响;根据多因素——包括(但不仅限于)临床表型、感染因素、环境因素和合并疾病等,研究COPD进展和急性加重易感性(频率、时间长短或严重程度)可能存在的不同;收集血液样本以进行可能的回顾性遗传学分析 

Objectives of Study:

The primary objectives: 1. To assess the effects of disease severity (by GOLD stage), the impact of trigger factors (smoking, pollution and/or viral infections) and seasonal variation on the incidence of COPD exacerbations in Guangzhou, China; 2. Assessment will include modelling the effects of these factors on exacerbations (frequency) and the durations and severity of the exacerbations, using appropriate statistical models. Secondary Objectives: 1. To investigate the impact of environmental factors (bacterial and viral triggers, pollution, smoking status) and exacerbations on disease progression of COPD assessed by lung function, patient reported outcomes, health economic measures, functional performance measures and computerised tomography; 2. To investigate the relationship of biochemical and imaging biomarkers to aspects of exacerbations, disease progression and disease severity of COPD; 3. To investigate the pathology and phenotypic differences in skeletal muscle of COPD subjects compared to control subjects and the impact of exacerbations on changes in muscle at onset and after resolution of the exacerbation; 4. To investigate the potential for differences in disease progression of COPD and susceptibility to exacerbations (by frequency, duration or severity) according to multiple factors including (but not restricted to) clinical phenotype, infective agent, environmental factors and co-morbidities; 5. To collect blood samples for possible retrospective genetic analysis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

COPD或有COPD风险的受试者 1. 在进行任一研究规定的步骤前,必须提供知情同意 2. 广州居民 3. 年龄在 40–79之间的男性和女性 4. 符合下列一种情况: 根据GOLD 2008 确诊处于COPD I期到IV的患者(表 1)或依据如下定义,有COPD风险 (即,GOLD 0期): 连续两年内,每年至少有三个月发生慢性咳嗽和咯痰,没有其他可解释的咳嗽原因,使用支气管扩张剂后FEV1 /FVC? 0.7 和FEV1 ? 80%正常预计值 能够阅读并且能用当地语言流利表达,足以完成研究问卷 对照组受试者 1. 在进行任一研究规定的步骤前,必须提供知情同意 2. 广州居民 3. 使用支气管扩张剂后FEV1 /FVC ?0.7 和FEV1 ? 80%正常预计值。没有任何呼吸系统疾病或慢性呼吸道症状 4. 年龄在 40–79之间的男性和女性,年龄和性别与COPD或有COPD风险的研究人群相匹配 5. 能够阅读并且能用本地语言流利表达,足以完成研究问卷 

Inclusion criteria

Subjects with COPD or "at risk" of COPD: 1. Provision of informed consent prior to any study-specific procedure; 2. Resident of Guangzhou area; 3. Men and women aged 40–79 years; 4. Either. 

排除标准:

COPD或有COPD风险的受试者: 1. 哮喘 (例如,根据 GINA 2008定义), 无COPD的症状或诊断 2. 重大疾病或紊乱,如心血管疾病、除COPD以外的肺病、消化道疾病、肝病、肾病、神经系统疾病、肌肉骨骼病、内分泌紊乱、代谢性疾病、恶性肿瘤、精神疾病和主要身体损伤等,研究者认为受试者参与这项研究可能带来风险或对研究结果产生影响,或受试者无参加本研究的能力 3. 慢性呼吸衰竭,包括需要定期氧疗 4. 在访视1之前最后1个月内发生严重的COPD急性加重 (指使用抗生素和/或口服/全身糖皮质激素或由于COPD病情恶化引起的住院) 5. 在访视1前的最后3个月内参加另一项研究,使用研究药物或献血( > 500毫升) 6. 在本研究期间有住院计划 7. 参与研究设计和执行(适用于阿斯利康人员或研究中心人员)。 8. 在访视1前的最后1个月内,COPD维持药物治疗发生变化,或者开始使用新的COPD治疗药物。 对照组受试者: 1. 重大疾病或紊乱,如心血管疾病,除COPD以外的肺病、消化道疾病、肝病、肾病、神经系统疾病、肌肉骨骼病、内分泌病、代谢病、恶性肿瘤、精神疾病和主要身体损伤等,研究者认为受试者由于参与这项研究,可能存在风险或影响研究结果,或受试者无参加本研究的能力; 2. 任何慢性呼吸道症状或慢性呼吸道疾病 3. 在访视1前的最后3个月内参加另一项研究中,并使用了研究药物或献血( > 500毫升)。 4. 在本研究期间有住院计划。 5. 涉及研究的设计和执行(适用于阿斯利康或研究中心人员) 4.2.2.1 M亚组排除标准 若符合如下任何一条排除标准,则受试者不能入选M亚组: 1. 使用任何抗血小板或抗凝药物,如肝素、华法林或阿司匹林进行常规治疗 2. 存在任何可能阻碍受试者在医院进行肌肉活检的身体损伤。 3. 任何原因引起的下肢活动障碍。 

Exclusion criteria:

Subjects with COPD or "at risk" of COPD: 1. Asthma (eg, as defined by GINA 2008) in the absence of COPD symptoms or diagnosis; 2. Significant disease or disorder, eg cardiovascular, pulmonary other than COPD, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject’s ability to participate in the study; 3. Chronic respiratory failure including requirement for regular oxygen therapy; 4. A severe exacerbation of COPD (defined as use of antibiotics and/or oral/systemic glucocorticosteroids or hospitalisation related to COPD worsening) within 1 month prior to Visit 1; 5. Participation in another study involving drug administration or blood donation (more than 500 ml) within 3 months of Visit 1; 6. Planned hospitalisation during the course of the study; 7. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site); 8. Change of maintenance medication or start of new medication for COPD within 1 month prior to Visit 1 Control Subjects; 9. Significant disease or disorder, eg cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject’s ability to participate in the study; 10. Any chronic respiratory symptom or chronic respiratory disease; 11. Participation in another study involving drug administration or blood donation (more than 500 ml) within 3 months of Visit 1; 12. Planned hospitalisation during the course of the study; 13. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site); 14. Exclusion criteria for sub-group M. Subjects must not be entered into Sub-group M if any of the following exclusion criteria are fulfilled: 15. Regular treatment with any anti-platelet or anti-coagulant medication, eg, heparin, warfarin or aspirin; 16. Any impairment that may prevent them from attending the hospital for the muscle biopsy assessment. 

研究实施时间:

Study execute time:

From2009-09-01To 2013-09-18 

征募观察对象时间:

Recruiting time:

From2009-09-11To 2010-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

24882

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital, Guangzhou Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

急性加重次数

指标类型:

主要指标 

Outcome:

the frequency of exacerbations

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

急性加重持续时间

指标类型:

主要指标 

Outcome:

The duration of exacerbations

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

急性加重的严重程度

指标类型:

主要指标 

Outcome:

The severity of exacerbations

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

ResMan临床试验公共管理平台

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

ResMan (www.medresman.org)

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Not stated

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-07-11
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