ChiCTR2000031893 版本V1.2 版本创建时间2020/04/13 23:29:29 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2000031893 

最近更新日期：

Date of Last Refreshed on：

 2020-04-13 23:26:45 

注册时间：

Date of Registration：

 2020-04-13 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

三种不同布的奈德方案治疗中国学龄前复发性喘息儿童的疗效

Public title：

Efficacy of three Different Budesonide Treatments in Chinese Preschool Children with Recurrent Wheezing

注册题目简写：

English Acronym：

研究课题的正式科学名称：

三种不同布的奈德方案治疗中国学龄前复发性喘息儿童的疗效

Scientific title：

Efficacy of three Different Budesonide Treatments in Chinese Preschool Children with Recurrent Wheezing

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：

李璐 

研究负责人：

孙萍 

Applicant：

Lu Li 

Study leader：

Ping Sun 

申请注册联系人电话：

Applicant telephone：

 +86 18679653216

研究负责人电话：

Study leader's
telephone：

+86 13970035358

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：

 465053498@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 supping158@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：

江西省南昌市永外正街17号南昌大学第一附属医院儿科

研究负责人通讯地址：

江西省南昌市永外正街17号南昌大学第一附属医院儿科

Applicant address：

17 Yongwai Main Street, Donghu District, Nanchang, Jiangxi, China

Study leader's address：

17 Yongwai Main Street, Donghu District, Nanchang, Jiangxi, 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：

南昌大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Nanchang University

研究负责人所在单位：

南昌大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Nanchang 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：

 2017-050

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：

南昌大学第一附属医院医学伦理委员会

Name of the ethic committee：

Medical ethics committee of The First Affiliated Hospital of Nanchang University

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-08-28 00:00:00

伦理委员会联系人：

孙文雄

Contact Name of the ethic committee：

WenXiongSun

伦理委员会联系地址：

江西省南昌市永外正街17号

Contact Address of the ethic committee：

17 Yongwai Main Street, Donghu District, Nanchang, Jiangxi, 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：

南昌大学第一附属医院

Primary sponsor：

The first affiliated hospital of nanchang university

研究实施负责（组长）单位地址：

江西省南昌市永外正街17号

Primary sponsor's address：

17 yongwai zhengjie, nanchang city, jiangxi province, 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)：

江西省

市(区县)：

南昌

Country：

China

Province：

Jiangxi

City：

Nanchang

单位(医院)：

南昌大学第一附属医院

具体地址：

南昌市永外正街17号

Institution
hospital：

The First Affiliated Hospital of Nanchang University

Address：

17 Yongwai Main Street, Donghu District, Nanchang

经费或物资来源：

江西省科技厅

Source(s) of funding：

Science and technology department of jiangxi province

研究疾病：

复发性喘息  

Target disease：

Recurrent Wheezing

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究利用TRACK评分来探讨和比较三种雾化吸入BUD方案干预中国学龄前复发性喘息儿童的临床控制情况。  

Objectives of Study：

To explore and compare the clinical control of three atomized inhalation budesonide (BUD) regimens for the treatment of Chinese preschool children with recurrent wheezing using Test for Respiratory and Asthma Control (TRACK).

药物成份或治疗方案详述：

这是一项前瞻性的随机对照研究。由一个独立人员使用计算机生成的随机数字列表将患儿随机分配至每日雾化吸入BUD组（每日组）、间歇高剂量雾化吸入BUD组（间歇高剂量组）、间歇中等剂量雾化吸入BUD组（间歇中等剂量组）三组各116例。三组儿童均接受为期52周不同方案的治疗，每4周经过门诊或电话进行评估，具体治疗方案如下： 每日组起始雾化吸入BUD 1mg/d，每4周进行病情评估（具体评估项目及控制水平分级依据为GINA BOX6-4,良好控制及部分控制均属于病情控制(16)，症状未控制继续原剂量用药；症状控制良好并维持12周减原剂量25%-50%，直到最后以0.25mg/d的剂量维持52周（7）。 间歇高剂量组在患儿出现鼻塞、咳嗽等先于喘息发作的呼吸道症状时雾化吸入BUD 1mg bid，连用7天，停药（9）； 间歇中等剂量组在患儿接触可疑过敏原及出现疑似呼吸道症状时雾化吸入BUD 0.5mg bid,直到有害因素去除或呼吸道症状缓解后3天停药（12）； 在治疗期间，监护人被要求在他们的孩子开始喘息时联系研究人员。急性期治疗包括氧吸入、气道清除、雾化SABA吸入、全身糖皮质激素、静脉抗生素和症状管理等，均可在研究人员指导下进行(3,16)。患儿病情稳定后继续原干预计划。 ３组均选用ＢＵＤ混悬液（普米克令舒，阿斯利康公司，澳大利亚，２ｍＬ：１ｍｇ）由空气压缩泵机（PARI GmbH, Germany ,PARI JuniorBOY SX）雾化吸入给药。 研究人员在喘息儿童入组时已向家属交代，在治疗中可以根据病情转其他治疗方案，并指导患者的监护人正确的雾化吸入，记录哮喘日记，记录症状、用药天数和剂量。本研究经参与医院伦理委员会批准(伦理编号2017-050)，并获得患者监护人的书面知情同意。 

Description for medicine or protocol of treatment in detail：

This was a prospective randomized controlled study. The children were randomly allocated to three groups using a computer-generated list of random numbers by an independent person : 116 in the daily group, 116 in the intermittent high-dose group and 116 in the intermittent general-dose group. All children were followed for a 52-week treatment period. The patients were assessed at every 4 weeks aftertreatment in the outpatient department or by phone. The specific treatment regimens were as follows: The children in the daily group were initially given inhaled BUD 1 mg once a day. Their conditions were assessed every 4 weeks (the specific assessment items and control levels were graded according to the Global Initiative for Asthma, box 6-4; both good control and partial control were considered disease control. If the symptom was well controlled and maintained for 12 weeks, the childs dose was reduced to 25%-50% of the previous dose until the final atomized inhaled dose was 0.25 mg, once a day; this dose was maintained to 52 weeks. If the symptom was not controlled, the original dose was continuously used. The children in the intermittent high-dose group were given inhaled BUD 1 mg twice daily for 7 days if they had a cough, runny nose and other respiratory symptoms before the wheezing began（10）. The children in the intermittent medium-dose group were given inhaled BUD inhalation 0.5 mg twice daily as soon as they contacted allergens or had nasal congestion, a runny nose, cough or any other suspicious respiratory symptoms. The drug was not stopped until the symptoms were reduced or risk factors were absent for 3 days. All three groups were treated with BUD suspension (Pulmicort Respules, Astra-Zeneca LP, Australia,2 mL: 1 mg)with a air compression pump of parry (PARI GmbH, Germany ,PARI JuniorBOY SX). Researchers have explained to their families that wheezing children can be transferred to other treatment options according to their condition, and instructed the patients guardians regarding proper spray inhalation, keeping an asthma diary, and recording the symptoms and medication days and dosages. During the treatment period, the guardians were directed to contact the researchers any time their child began wheezing. Acute phase treatment, including oxygen inhalation, airway clearing, atomized SABA inhalation, systemic glucocorticoids, intravenous antibiotics and symptom management, could be given under the direction of the subject researcher. The original intervention plan was continued after the childs condition was stabilized 

纳入标准：

满足mAPI阳性：1）过去12个月内≥4次持续24小时以上的喘息急性发作；2）并包括以下一项主要危险因素或2项次要危险因素。主要标准包括父母哮喘病史、医生诊断的特应性皮炎、对至少1种空气过敏原过敏。次要标准包括与感冒无关的喘息、外周血嗜酸性粒细胞≥4%、对牛奶、鸡蛋或花生过敏。

Inclusion criteria

We enrolled children who met all the following criteria for mAPI positive 1) have ≥4 wheezing episodes in the past year,;2) meeting at least 1 major criterion or at least 2 minor criteria. The major criteria include parental history of asthma, physician-diagnosed atopic dermatitis, and allergic sensitization to at least 1 aeroallergen. The minor criteria include wheezing unrelated to colds, peripheral blood eosinophils ≥4%, and allergic sensitization to milk, egg, or peanuts.

排除标准：

排除标准如下:1)其喘息是由器质性病变和机械因素引起;2) 52周内服用糖皮质激素6次以上或住院2次以上;3)曾使用其他哮喘控制药物;4)监护人不知道孩子的病史或不同意参与研究。

Exclusion criteria：

Exclusion criteria were as follow:1)their wheezing was caused by organic lesions and mechanical factors; 2)had received more than six systemic glucocorticoids or had been hospitalized more than two times within 52-weeks; 3)had used other asthma control drugs; 4)their guardians did not know the child’s medical history or did not agree to participate in the study.

研究实施时间：

Study execute time：

从 From 2015-01-01 00:00:00至 To 2018-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-01-01 00:00:00 至 To 2018-01-30 00:00:00

干预措施：

Interventions：

组别：

每日组

样本量：

 116

Group：

daily group

Sample size：

干预措施：

每日组起始雾化吸入布的奈德 1mg/d，每4周进行病情评估，症状未控制继续原剂量用药；症状控制良好并维持12周减原剂量25%-50%，直到最后以0.25mg/d的剂量维持52周

干预措施代码：

Intervention：

initially given inhaled BUD 1 mg once a day, assessed every 4 weeks; if the symptom was well controlled and maintained for 12 weeks, the dose was reduced to 25%-50% of the previous dose until the final dose was 0.25 mg, once a day, maintained to 52 weeks)

Intervention code：

组别：

间歇高剂量组

样本量：

 116

Group：

an intermittent high-dose group

Sample size：

干预措施：

间歇高剂量组在患儿出现鼻塞、咳嗽等先于喘息发作的呼吸道症状时雾化吸入布的奈德 1mg bid，连用7天，停药

干预措施代码：

Intervention：

1 mg twice daily for 7 days, starting early during a predefined respiratory tract illness

Intervention code：

组别：

间歇中等剂量组

样本量：

 116

Group：

an intermittent medium-dose group

Sample size：

干预措施：

间歇中等剂量组在患儿接触可疑过敏原及出现疑似呼吸道症状时雾化吸入布的奈德 0.5mg bid,直到有害因素去除或呼吸道症状缓解后3天停药

干预措施代码：

Intervention：

0.5 mg twice daily as soon as they contacted allergens or had nasal congestion, a runny nose, cough or any other suspicious respiratory symptoms, continuing until the symptoms were reduced or risk factors were absent for 3 days

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江西 

市(区县)：

 南昌 

Country：

China

Province：

Jiangxi

City：

Nanchang

单位(医院)：

 南昌大学第一附属医院 

单位级别：

 三甲医院 

Institution
hospital：

The first affiliated hospital of nanchang university

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

儿童呼吸和哮喘控制测试评分

指标类型：

主要指标

Outcome：

The Test for Respiratory and Asthma Control in Kids scores

Type：

Primary indicator

测量时间点：

治疗前及治疗后每4周

测量方法：

门诊或电话进行问卷调查

Measure time point of outcome：

before and every 4 weeks after treatment

Measure method：

Outpatient or telephone questionnaire survey

指标中文名：

在52周的治疗期间全身糖皮质激素疗程

指标类型：

次要指标

Outcome：

the number of systemic corticosteroids courses during the 52-week treatment period.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

在52周的治疗期间喘息发作次数

指标类型：

次要指标

Outcome：

the number of wheezing episodes during the 52-week treatment period.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

在52周的治疗期间急诊次数

指标类型：

次要指标

Outcome：

urgent care visits for wheezing during the 52-week treatment period.

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 1 岁 years
最大 Max age 5 岁 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）：

这是一项前瞻性的随机对照研究。由一个独立人员使用计算机生成的随机数字列表将患儿随机分配至每日雾化吸入BUD组（每日组）、间歇高剂量雾化吸入BUD组（间歇高剂量组）、间歇中等剂量雾化吸入BUD组（间歇中等剂量组）三组各116例。

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

This was a prospective randomized controlled study. The children were randomly allocated to three groups using a computer-generated list of random numbers by an independent person : 116 in the daily group, 116 in the intermittent high-dose group and 116 in the intermittent general-dose group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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)：

是否共享原始数据：

IPD sharing

否No

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）：

发表论文

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

Article publishing in Journal.

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：

病例记录表

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

Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2020-04-13 23:24:33