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哮喘患者GLCCI1基因多态性分布对糖皮质激素疗效的影响及其机制研究
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注册号:

Registration number:

ChiCTR-RCC-13003634 

最近更新日期:

Date of Last Refreshed on:

2016-03-25 

注册时间:

Date of Registration:

2013-09-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

哮喘患者GLCCI1基因多态性分布对糖皮质激素疗效的影响及其机制研究 

Public title:

Asthma GLCCI1 gene polymorphisms on glucocorticoid therapeutic effect andits mechanism 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

GLCCI1应答糖皮质激素效应调控哮喘小鼠肾上腺髓质嗜铬细胞转分化的表观遗传学机制 

Scientific title:

GLCCI1 response effect of glucocorticoid regulation asthmatic mice adrenal medulla chromaffin cell transdifferentiation epigenetic mechanisms 

研究课题代号(代码):

Study subject ID:

81270080 

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:

荀秋芬 

研究负责人:

冯俊涛 

Applicant:

Qiufen Xun 

Study leader:

Juntao Feng 

申请注册联系人电话:

Applicant telephone:

+86 13873120540 

研究负责人电话:

Study leader's telephone:

+86 13786145799 

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:

710980956@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

Jtfeng1976@hotmail.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:

湖南省长沙市开福区湘雅路87号中南大学湘雅医院呼吸内科 

研究负责人通讯地址:

湖南省长沙市开福区湘雅路87号中南大学湘雅医院呼吸内科 

Applicant address:

87 Xiangya Road, Changsha, Hunan, China 

Study leader's address:

87 Xiangya Road, Changsha, Hunan, China 

申请注册联系人邮政编码:

Applicant postcode:

410008 

研究负责人邮政编码:

Study leader's postcode:

410008 

申请人所在单位:

中南大学湘雅医院 

Applicant's institution:

Xiangya Hospital, Central South University 

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:

ChiECRCT-2013002 

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:

中国注册临床试验伦理审查委员会 

Name of the ethic committee:

Chinese Clinical Trial Register ethical review committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-01-23 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

中南大学湘雅医院 

Primary sponsor:

Xiangya Hospital, Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市开福区湘雅路87号中南大学湘雅医院呼吸内科 

Primary sponsor's address:

87 Xiangya Road, Changsha, Hunan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

支气管哮喘 

Target disease:

bronchial asthma 

研究疾病代码:

 

Target disease code:

 

研究类型:

相关因素研究 

Study type:

Relative factors research 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

了解GLCCI1基因表达水平及rs37973位点单核苷酸多态性与哮喘的关联,以增进对GLCCI1与哮喘的认识,为哮喘提供早期筛查方法,从而及早对哮喘患者进行干预,并为哮喘的基因治疗提供线索。 通过研究GLCCI1基因结构及表达改变与糖皮质激素生物学效应弱化之间的应答关系,初步阐明哮喘状态下肾上腺髓质嗜铬细胞发生神经元转分化的表观遗传学机制,为哮喘的早期防控及个体化治疗提供新的线索,使患者达到更好地长期哮喘控制,并节约治疗费用。 

Objectives of Study:

To learn the association of GLCCI1 gene expression levels andrs37973 single nucleotide polymorphism with asthma. By studying the relationship between the change of GLCCI1 structure andexpression andweakened biological effects of glucocorticoid, We hope to clarify the epigenetic mechanism of neuron transdifferentiation of the adrenal medulla Chromaffin cells in asthma. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

1、符合2008年中华医学会呼吸病学分会哮喘学组制定的诊断标准的轻中度哮喘持续期患者。 2、年龄18-70岁,性别不限。 3、支气管舒张试验或激发试验阳性。 4、试验前4周内未使用全身或吸入糖皮质激素。 5、试验前2周内未使用白三烯受体调节剂、茶碱衍生物及肥大细胞膜稳定剂。 6、试验前1周内未使用长效β2受体激动剂、口服β2受体激动剂或吸入性抗胆碱能受体制剂。 7、试验前4周内无呼吸道感染及全身感染,尤其是严重呼吸道感染、肺结核、真菌感染。 8、试验前4周内未因急性哮喘加重而住院治疗。 9、试验前4周内未接受任何研究药物治疗。 10、无吸入糖皮质激素、β2受体激动剂过敏。 11、无严重的心、肝、肾及其他全身性疾患。 12、同意加入此研究并签署书面知情同意书。 

Inclusion criteria

1. mild to moderate persistent asthma that meet the 2008 diagnostic criteria established by Chinese Medical Association Respiratory Diseases Asthma Study Group; 2. Age 18-70 years old , male or female; 3. Bronchial provocation test or Bronchodilation test positive; 4. No use of systemic or inhaled corticosteroids during the last 4 weeks; 5. No use of leukotriene receptor modulators, theophylline derivatives andmast cell stabilizers Within 2 weeks before the test; 6. No use of long-acting β2 agonists, oral β2 agonists or inhaled anti- cholinergic receptor 1 week before the test; 7.Abscent of without respiratory infections andsystemic infections, particularly acute respiratory infections , tuberculosis, fungal infections 4 weeks before the test; 8. Abscent of acute asthma exacerbations andhospitalizations 4 weeks before the test; 9. Did not receive any study medication 4 weeks before the test; 10. No inhaled corticosteroids, β2 agonists allergies; 11. No serious heart, liver, kidney andother systemic disorders; 12. Agreed to join the study andsigned a written informed consent 

排除标准:

1、间歇状态、重度及急性加重期的哮喘患者。 2、职业性哮喘或与阿司匹林或非甾体类抗炎药相关的哮喘。 3、试验前1年内发生过危及生命的急性哮喘加重。 4、试验前6月内使用抗IgE单抗。 5、近期使用可导致支气管痉挛或影响肺功能的药物。 6、对吸入激素、β2受体激动剂过敏,对抗生素过敏,既往有食物或药物相关的严重过敏反应。 7、有严重的心、肝、肾、肺、消化道、内分泌及血液系统疾病等,治疗或未治疗的任何器官系统的恶性肿瘤。 8、试验前1年内有明显的潜在医疗状况,可能影响结果的解释(如感染、血液疾病、肾病、肝病、冠心病或其他心血管疾病、脑血管疾病、内分泌或胃肠道疾病。) 9、有除哮喘外的其他肺部活动性疾病史(如慢性支气管炎、慢性阻塞性肺疾病、变应性肉芽肿血管炎、变态反应性支气管肺曲菌病)。 10、试验前1年吸烟或吸烟平均>20年支,既往吸烟者须在试验前已戒烟12个月。 11、有酗酒及滥用药物史。 12、妊娠期及哺乳期妇女。 13、有精神异常。 14、研究过程中有过因哮喘急性发作住院或未能完成全过程测定。 15、预计不能完成研究或不能持续参加计划访视。 16、不能或不愿依从研究操作或研究访视。 

Exclusion criteria:

1. Intermittent status asthma, severe asthma andacute exacerbation of asthma; 2. Occupational asthma or aspirin or non- steroidal anti-inflammatory drugs -related asthma; 3. Life-threatening acute asthma exacerbations occurred within one year before the test; 4. Using of monoclonal anti-IgE Within 6 months prior to the test; 5. Recent drug use that can lead to bronchospasm or affect the Forced lung function; 6. Allergic to inhaled corticosteroids, β2 agonists allergy, antibiotics or a history of food or drug -related serious allergic reactions; 7. Have serious disease of heart, liver, kidneys, lungs, gastrointestinal tract, endocrine andblood system diseases. Treated or untreated malignancies of any organ; 8. Obvious potential medical conditions( such as infection, blood diseases, kidney disease, liver disease, coronary heart disease or other cardiovascular diseases , cerebrovascular diseases, endocrine or gastrointestinal disease. ) that may affect the interpretation of the results 1 year before the test. 9. Other history of active lung diseases except asthma such as chronic bronchitis , chronic obstructive pulmonary disease, allergic granulomatous vasculitis, allergic bronchopulmonary aspergillosis; 10. Before the test, an average annual smoking. Former smokers should quit smoking in the 12 months prior to trial; 11. History of alcoholism anddrug abuse; 12. Pregnant andlactating women; 13. With psychiatric disorders; 14. had a hospitalization due to asthma exacerbations or failed to complete the whole process of determination during the study; 15. Not expected to complete the study or unable to continue to participate in planned visits; 16. Unable or unwilling to comply with research operations or study visits. 

研究实施时间:

Study execute time:

From2013-03-01To 2014-12-31 

干预措施:

Interventions:

组别:

哮喘病例组

样本量:

180

Group:

asthma patients

Sample size:

干预措施:

无干预措施

干预措施代码:

Intervention:

no intervention

Intervention code:

组别:

健康受试者

样本量:

180

Group:

Healthy subjects

Sample size:

干预措施:

Healthy subjects

干预措施代码:

Intervention:

no intervention

Intervention code:

组别:

GLCCI1野生型

样本量:

30

Group:

Wild type of GLCCI1

Sample size:

干预措施:

辅舒酮吸入治疗

干预措施代码:

Intervention:

treatment with Flixotide

Intervention code:

组别:

GLCCI1杂合子

样本量:

30

Group:

Heterozygous of GLCCI1

Sample size:

干预措施:

辅舒酮吸入治疗

干预措施代码:

Intervention:

treatment with Flixotide

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

中南大学湘雅医院 

单位级别:

三甲 

Institution
hospital:

Xiangya Hospital, Central South University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

GLCCI1 SNP分型

指标类型:

主要指标 

Outcome:

genotype of GLCCI1

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

GLCCI1表达水平

指标类型:

主要指标 

Outcome:

expression level of GLCCI1

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺功能检查

指标类型:

主要指标 

Outcome:

forced pulmonary function test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

blood routine examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ACT评分

指标类型:

次要指标 

Outcome:

ACT score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

AQLQ评分

指标类型:

次要指标 

Outcome:

AQLQ score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NGF 表达水平

指标类型:

次要指标 

Outcome:

NGF expression

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾上腺素表达水平

指标类型:

次要指标 

Outcome:

expression level of Epinephrine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

去甲肾上腺素表达水平

指标类型:

次要指标 

Outcome:

expression level of Norepinephrin

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:

征募研究对象情况:

Recruiting status:

结束

Completed

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):

本试验根据患者本身的GLCCI1的SNP分型进行分组

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

This test is based on the patient s own GLCCI1 grouping of SNP genotyping

盲法:

Blinding:

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):

NA

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

NA

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:

NA

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

NA

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-09-26
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