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加巴喷丁治疗间质性肺病相关难治性咳嗽的随机、双盲和安慰剂对照临床研究
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注册号:

Registration number:

ChiCTR2100045202 

最近更新日期:

Date of Last Refreshed on:

2021-11-15 

注册时间:

Date of Registration:

2021-04-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

加巴喷丁治疗间质性肺病相关难治性咳嗽的随机、双盲和安慰剂对照临床研究 

Public title:

A randomized, double-blind, placebo-controlled clinical study of gabapentin in the treatment of interstitial pulmonary disease associated refractory cough 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

加巴喷丁治疗间质性肺病相关难治性咳嗽的随机、双盲和安慰剂对照临床研究 

Scientific title:

A randomized, double-blind, placebo-controlled clinical study of gabapentin in the treatment of interstitial pulmonary disease associated refractory cough 

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:

王璇 

研究负责人:

余莉 

Applicant:

Wang Xuan 

Study leader:

Yu Li 

申请注册联系人电话:

Applicant telephone:

+86 13918745569 

研究负责人电话:

Study leader's telephone:

+86 13816699078 

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:

xuan2018@tongji.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

96778@tongji.edu.cn 

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:

上海市普陀新村路389号 

研究负责人通讯地址:

上海市普陀新村路389号 

Applicant address:

389 Xincun Road, Putuo District, Shanghai 

Study leader's address:

389 Xincun Road, Putuo District, Shanghai 

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:

上海市同济医院(同济大学附属同济医院) 

Applicant's institution:

Tongji Hospital, Tongji University School of Medicine 

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:

(同)伦审第(2021-006)号 

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:

同济大学附属同济医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Tongji Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-01-13 

伦理委员会联系人:

宣淼 

Contact Name of the ethic committee:

Xuan Miao 

伦理委员会联系地址:

上海市普陀区新村路389号 

Contact Address of the ethic committee:

389 Xincun Road, Putuo District, Shanghai 

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:

上海市同济医院(同济大学附属同济医院) 

Primary sponsor:

Tongji Hospital, Tongji University School of Medicine 

研究实施负责(组长)单位地址:

上海市普陀新村路389号 

Primary sponsor's address:

389 Xincun Road, Putuo District, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市同济医院(同济大学附属同济医院)

具体地址:

普陀新村路389号

Institution
hospital:

Tongji Hospital, Tongji University School of Medicine

Address:

389 Xincun Road, Putuo District

经费或物资来源:

同济大学附属同济医院 

Source(s) of funding:

Tongji Hosipital, Tongji University School of Medicine 

研究疾病:

间质性肺病相关难治性咳嗽 

Target disease:

interstitial pulmonary disease associated refractory cough 

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:

探索性研究/预试验 

Study phase:

研究目的:

1.主要目的:通过随机、双盲、安慰剂对照的临床研究,探究加巴喷丁能否改善间质性肺病患者的咳嗽症状。 2.次要目的:探究加巴喷丁改善间质性肺病患者咳嗽症状的可能机制。 

Objectives of Study:

1. Main objective: to investigate whether gabapentin improves cough symptoms in patients with interstitial lung disease in a randomized, double-blind, placebo-controlled clinical study. 2. Secondary purpose: to investigate the possible mechanism by which gabapentin improves cough symptoms in patients with interstitial pulmonary disease. 

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:

1.18岁≤年龄≤70岁; 2.符合ILD的患者,包括CTD-ILD、IPAF、IPF; 3.根据病史和实验室检查不能诊断上气道咳嗽综合征、咳嗽变异性哮喘和嗜酸粒细胞性支气管炎等,或针对这些病因治疗咳嗽不能缓解及仅部分缓解; 4.无加巴喷丁治疗禁忌症; 5.能够阅读、理解并给出书面的知情同意。 

Inclusion criteria

1. Aged >= 18 years and <= 70 years; 2. Patients in line with ILD, including CTD-ILD, IPAF, IPF; 3. Upper airway cough syndrome, cough-variant asthma and eosinophilic bronchitis cannot be diagnosed according to the medical history and laboratory examination, or the cough cannot be relieved or only partially relieved by treatment for these causes; 4. No contraindication of gabapentin treatment; 5. Be able to read, understand and give written informed consent. 

排除标准:

1.妊娠、哺乳期妇女或拒绝签署知情同意书者; 2.正在吸烟或戒烟≤2年; 3.2个月内使用过加巴喷丁者; 4.8周内有呼吸道感染史; 5.处于间质性肺病急性加重期(acute exacerbation of interstitial pneumonitis,AEIP)的患者; 6.动脉血气分析提示呼吸衰竭; 7.有严重心、肝、肾等重要脏器和血液、内分泌系统病变; 8.存在活动性感染,糖皮质激素及免疫抑制治疗可使病情加重者; 9.乙型肝炎病毒表面抗原阳性,或丙肝抗体阳性; 10.精神疾患或其他原因不能配合治疗者; 11.过敏体质或多种药物过敏者; 12.研究者认为存在不适合进入研究的其它情况。 

Exclusion criteria:

1. Pregnant or lactating women or those who refuse to sign the informed consent; 2. Smoking or quitting smoking for no more than 2 years; 3. Patients who have used gabapentin within 2 months; 4. A history of respiratory infection within 8 weeks; 5. Patients with acute exacerbation of interstitial pneumonitis (AEIP); 6. Arterial blood gas analysis suggested respiratory failure; 7. With severe heart, liver, kidney and other important organs and blood and endocrine system lesions; 8. With active infection, glucocorticoid and immunosuppressive therapy can aggravate the disease; 9. Hepatitis B virus surface antigen positive or hepatitis C antibody positive; 10. Mentally ill or unable to cooperate with treatment for other reasons; 11. Patients with allergies or allergies to multiple drugs; 12. Other circumstances considered by the researcher to be unsuitable for study participation. 

研究实施时间:

Study execute time:

From2021-05-01To 2023-12-31 

征募观察对象时间:

Recruiting time:

From2021-05-01To 2022-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

42

Group:

Experimental group

Sample size:

干预措施:

加巴喷丁

干预措施代码:

Intervention:

gabapentin

Intervention code:

组别:

对照组

样本量:

42

Group:

Control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市同济医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Tongji Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

咳嗽症状积分

指标类型:

主要指标 

Outcome:

Cough symptom score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

间质性肺病的活动性评分

指标类型:

次要指标 

Outcome:

Activity score of interstitial lung 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:

莱切斯特咳嗽问卷

指标类型:

主要指标 

Outcome:

Leicester Cough Questionnaire

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

辣椒素咳嗽敏感性

指标类型:

主要指标 

Outcome:

Capsaicin cough sensitivity

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:

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 18 years
最大 Max age 70 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):

按照计算机设定的随机数字法对每例患者进行分组,并实行性别分层。

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

According to the random number method set by the computer, each patient is divided into groups, and gender stratification is implemented.

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

未说明 请阅读网页注册指南中关于“原始数据共享”的内容。

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

Not stated

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:

病例登记表

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

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2021-04-08
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