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Arbidol for COPD Exacerbations: a randomized controlled trial
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注册号:

Registration number:

ChiCTR1900022146 

最近更新日期:

Date of Last Refreshed on:

2019-09-29 

注册时间:

Date of Registration:

2019-03-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

阿比多尔改善慢阻肺急性加重 

Public title:

Arbidol for COPD Exacerbations: a randomized controlled trial 

注册题目简写:

阿比多尔改善慢阻肺急性加重研究 

English Acronym:

TEA-AECOPD Study 

研究课题的正式科学名称:

前瞻性、多中心、随机、双盲、安慰剂对照、为期52周评价盐酸阿比多尔胶囊对改善慢性阻塞性肺疾病患者中度或重度急性发作频度和程度的有效性和安全性临床研究 

Scientific title:

A 52-week Multicenter, Randomized, Double-blind, Placebo-controlled, trial for Evaluation of the Efficacy and Safety of Arbidol Hydrochloride Capsules in Reducing the Frequency of Moderate or Severe Acute Exacerbations in Patients With Chronic Obstructive Pulmonary Disease.  

研究课题代号(代码):

Study subject ID:

 

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:

李钰 

研究负责人:

赵立 

Applicant:

Yu Li 

Study leader:

Li Zhao 

申请注册联系人电话:

Applicant telephone:

+86 18940256331 

研究负责人电话:

Study leader's telephone:

+86 18940251639 

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:

sundy_liyu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhaol@sj-hospital.org 

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:

中国辽宁省沈阳市和平区三好街36号 

研究负责人通讯地址:

中国辽宁省沈阳市和平区三好街36号 

Applicant address:

36 Sanhao Street, Heping District, Shenyang, Liaoning, China 

Study leader's address:

36 Sanhao Street, Heping District, Shenyang, Liaoning, China 

申请注册联系人邮政编码:

Applicant postcode:

110000 

研究负责人邮政编码:

Study leader's postcode:

110000 

申请人所在单位:

盛京医院 

Applicant's institution:

Shengjing Hospital 

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:

2019PS405K(X3) 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

中国医科大学附属盛京医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Shengjing Hospital affiliated to China Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-20 

伦理委员会联系人:

王洪 

Contact Name of the ethic committee:

Wang Hong 

伦理委员会联系地址:

沈阳市和平区三好街36号 

Contact Address of the ethic committee:

36 Sanhao Street, Heping District, Shenyang 

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:

盛京医院 

Primary sponsor:

Shengjing Hospital 

研究实施负责(组长)单位地址:

中国辽宁省沈阳市和平区三好街36号 

Primary sponsor's address:

36 Sanhao Street, Heping District, Shenyang, Liaoning, 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):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

盛京医院

具体地址:

和平区三好街36号

Institution
hospital:

Shengjing Hospital

Address:

36 Sanhao Street, Heping District

国家:

中国

省(直辖市):

辽宁省

市(区县):

大连

Country:

China

Province:

Liaoning

City:

Dalian

单位(医院):

中国医科大学附属盛京医院大连医院

具体地址:

金普新区黄海西路146号

Institution
hospital:

Dalian Hospital affilated to Shengjing Hospital of China Medical University

Address:

146 Huanghai Road West, Jinpu New District

国家:

中国

省(直辖市):

山西省

市(区县):

孝义市

Country:

China

Province:

Shanxi

City:

Xiaoyi

单位(医院):

山西省孝义市人民医院

具体地址:

新义东街20号

Institution
hospital:

Xiaoyi City People's Hospital, Shanxi Province

Address:

20,Xinyi Street East

国家:

中国

省(直辖市):

河南

市(区县):

开封

Country:

China

Province:

Henan

City:

Kaifeng

单位(医院):

河南大学淮河医院

具体地址:

龙亭区西门大街115号

Institution
hospital:

Huaihe Hospital of Henan University

Address:

115 Ximen Street, Longting District

国家:

中国

省(直辖市):

辽宁

市(区县):

大连

Country:

China

Province:

Liaoning

City:

Dalian

单位(医院):

中国人民解放军联勤保障部队第967医院

具体地址:

西岗区胜利路80号

Institution
hospital:

The 967th Hospital

Address:

80 Shengli Street, Xigang District

经费或物资来源:

北京医卫健康公益基金会 

Source(s) of funding:

Beijing Medical and Health Foundation 

研究疾病:

慢性阻塞性肺疾病 

Target disease:

Chronic obstructive pulmonary disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

探讨盐酸阿比多尔胶囊减低慢阻肺患者中度或重度急性加重频度及程度的有效性及安全性。 

Objectives of Study:

To explore the efficacy and safety of abidol hydrochloride capsule in reducing the frequency and degree of moderate or severe acute exacerbation in patients with COPD. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 受试者类型:门诊病人 2. 知情同意:参与研究前在书面知情同意书上签名并注明日期。 3. 年龄:筛选(访视0)时的年龄大于或等于40岁。 4. 具有咳嗽、咳痰、或气短等呼吸道症状。 5. 危险因素暴露(宿主因素,吸烟,职业,生物燃料,空气污染,等)。 6. 吸入支气管扩张剂后FEV1/FVC<0.70。 7. 1年内中度或重度急性加重≧2次,或因急性加重住院≧1次。 8. 研究者评估认为依从性良好。 

Inclusion criteria

1. Patients from Outpatient clinic 2. Informed consent and assent must be obtained before any study assessment is performed; 3. Aged ≥ 40 years; 4. Continuous respiratory symptoms, such as chronic cough, sputum or shortness of breath etc.; 5. Exposure to risk factors: Host factors, Tobacco, Occupation, Indoor/outdoor pollution; 6. FEV1/FVC less than 0.70 after withholding bronchodilator; 7. 2 or more acute exacerbations of COPD within the 12 months prior to visit 0. Or more than 1 hospitalizations due to AECOPD within the 12 months prior to visit 0; 8. Good compliance. 

排除标准:

符合以下任一标准的受试者不得入选本研究: 1. 患有慢阻肺以外的显著疾病或状况,根据研究者的判断,会对研究结果和受试者参加本研究的能力有影响。 2. 其他呼吸系统疾病:必需排除的疾病为活动性肺部感染(如结核病等)、肺癌。有临床意义的支气管扩张症(高分辨CT显示支气管扩张症导致反复急性加重)、原发性肺动脉高压、结节病、间质性肺病、未控制的睡眠呼吸暂停(研究者判断疾病的严重程度会影响研究实施)、支气管哮喘(哮喘-慢阻肺重叠不在排除标准之中)、肺源性心脏病-心功能III级以上。 3. 在入组前6个月内患有不稳定性缺血性心脏病、左心衰竭或心肌梗死;在过去3个月内,具有急性冠状动脉综合征或接受过经皮冠状动脉介入疗法或冠状动脉旁路移植术。 4. 临床未控制的高血压,指服用降压药后血压高于160/95mmHg。 5. 违背禁用药物使用规定: 禁用药物的时间规定,指距离访视V0的时间间隔。 口服>10mg泼尼松龙或等效的全身性皮质类固醇给药 ≤4周; 抗生素(用于任何适应症) ≤4周; 任何其他研究性药物 ≤30天或5个半衰期,以较长者为准; 新开始慢阻肺的标准治疗(LAMA、ICS/LABA、SAMA、SAMA、茶碱或粘液溶解剂) ≤4周。 6. 1年内注射过流感疫苗或其它病毒疫苗。 7. 距最近一次慢阻肺急性加重治疗结束少于4周,或最近一次急性加重发作在6周之内。 8. 对阿比多尔有过敏史。 9. 与研究中心有隶属关系:参与本研究的研究者、助理研究者、研究协调员、参与研究者或研究中心的雇员或上述人员的直系亲属。 10. 其他临床试验结束1个月以内。 11. 肝功能明显异常,满足AST或ALT>2倍正常值上限或总胆红素>1.3倍正常值上限。 

Exclusion criteria:

1. Patients with any chronic diseases except COPD which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study; 2. Patients with a history of chronic lung disease other than COPD, including (but not limited to) active tuberculosis, lung cancer, clinically significant bronchiectasis, primary pulmonary hypertension, sarcoidosis, interstitial lung disease, asthma (other than asthma COPD overlap), severe cor pulmonale; 3. Patients with acute coronary syndrome(ACS) or acute left heart failure within the 6 months prior to visit 0. Patients accepted Coronary interventional therapy or coronary artery bypass grafting due to ACS within the 3 months prior to visit 0; 4. Patients with uncontrolled hypertension; 5. Patients who started oral >10mg prednisolone or Equivalent systemic corticosteroids within 4 weeks prior to Visit 1. Or patients who received antibiotics within 4 weeks prior to Visit 1. Or patients who received standard treatment for COPD within 4 weeks prior to Visit 1. Or use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer; 6. Patients who received influenza vaccine or other viral vaccine within the 12 months prior to visit 0; 7. The end of AECOPD therapy was within the 4 weeks prior to visit 0. Or Occurrence of AECOPD within the 6 weeks prior to visit 0; 8. History of arbidol sensitivity; 9. No person directly associated with the administration of the study is allowed to participate as a study subject; 10. Use of other investigational intervention within within 30 days; Patients with obviously abnormal liver function, AST or ALT>2 times the upper limit of normal value or total; 11. bilirubin>1.3 times the upper limit of normal value. 

研究实施时间:

Study execute time:

From2019-01-09To 2022-08-31 

干预措施:

Interventions:

组别:

阿比多尔组

样本量:

660

Group:

Arbidol group

Sample size:

干预措施:

按需服用 阿比多尔200mg 日三次 口服

干预措施代码:

Intervention:

Abidol 200 mg orally three times a day

Intervention code:

组别:

对照组

样本量:

330

Group:

control group

Sample size:

干预措施:

按需服用 安慰剂 日三次 口服

干预措施代码:

Intervention:

Take placebo three times a day

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

盛京医院 

单位级别:

三级甲等 

Institution
hospital:

Shengjing Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

慢阻肺患者中度或重度急性加重发生频度

指标类型:

主要指标 

Outcome:

Frequency of moderate or severe acute exacerbation in patients with chronic obstructive pulmonary disease

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

慢阻肺患者急性加重导致住院发生频度

指标类型:

次要指标 

Outcome:

Frequency of hospitalization due to acute exacerbation of chronic obstructive pulmonary disease

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第一次使用研究药物后距下一次急性加重发作时间(天)

指标类型:

次要指标 

Outcome:

The time between the first use of the study drug and the next acute exacerbation (days)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

慢阻肺中重度急性加重的平均持续时间

指标类型:

次要指标 

Outcome:

Average duration of moderate to severe acute exacerbation of chronic obstructive pulmonary disease

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

医疗保健资源的利用(慢阻肺需要看门诊的计划外就诊次数,因慢阻肺被送往急诊室抢救次数,慢阻肺加重住院次数,慢阻肺加重导致插管抢救次数)

指标类型:

次要指标 

Outcome:

Utilization of medical care resources (the number of unplanned outpatient visits for COPD, the number of rescues for COPD being sent to the emergency room, the number of hospitalizations for COPD aggravating, and the number of intubation rescues for COPD aggravating)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

慢阻肺患者1年后FEV1的下降程度,即与基线相比△FEV1数值

指标类型:

次要指标 

Outcome:

The decrease of FEV1 in COPD patients after one year, i.e. the value of Delta FEV1 compared with baseline

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

需要住院的慢阻肺急性加重患者的呼吸道病毒构成情况

指标类型:

次要指标 

Outcome:

Respiratory viral composition in patients with acute exacerbation of chronic obstructive pulmonary disease requiring hospitalization

Type:

Secondary 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:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 40 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):

统计专业人员利用SAS软件生成随机分配表。

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

Statistical professionals use SAS software to generate random allocation tables.

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

2022年11月通过发表文章

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

By publishing articles in 11/2022

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:

EDC

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

EDC

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-03-27
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