中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR-TRC-11001323
最近更新日期： Date of Last Refreshed on：	2015-07-11 15:25:50
注册时间： Date of Registration：	2011-04-20 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	口服糖皮质激素对嗜酸粒细胞性及非嗜酸粒细胞性鼻息肉患者治疗效果的研究
Public title：	Research on clinical efficacy of oral glucocorticoid in the treatment of Eosinophilic nasal polyps and Non-eosinophilic nasal polyps
注册题目简写：
English Acronym：
研究课题的正式科学名称：	口服糖皮质激素对嗜酸粒细胞性及非嗜酸粒细胞性鼻息肉患者治疗效果的研究
Scientific title：	Research on clinical efficacy of oral glucocorticoid in the treatment of Eosinophilic nasal polyps and Non-eosinophilic nasal polyps
研究课题代号(代码)： Study subject ID：	201101
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：	曾明	研究负责人：	刘争
Applicant：	Ming Zeng	Study leader：	Zheng Liu
申请注册联系人电话： Applicant telephone：	+86 27 83663334	研究负责人电话： Study leader's telephone：	+86 27 83663334
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：	zmsx77@163.com	研究负责人电子邮件： Study leader's E-mail：	zmsx77@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：	武汉市解放大道1095号	研究负责人通讯地址：	武汉市解放大道1095号
Applicant address：	1095 Jie Fang Avenue, Hankou, Wuhan, Hubei, China	Study leader's address：	1095 Jie Fang Avenue, Hankou, Wuhan, Hubei, China
申请注册联系人邮政编码： Applicant postcode：	430030	研究负责人邮政编码： Study leader's postcode：	430030
申请人所在单位：	华中科技大学同济医学院附属同济医院耳鼻咽喉-头颈外科
Applicant's institution：	Department of Otorhinolaryngology-head and Neck Surgery, Tongji Hospital of Tongji Medical College
研究负责人所在单位：
Affiliation of the Leader：

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：	【2010】伦审字（149）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：	华中科技大学同济医学院医学伦理委员会
Name of the ethic committee：	Ethics Committee of Tongji Medical College of Huazhong University of Science and Technology
伦理委员会批准日期： Date of approved by ethic committee：	2011-01-11 00:00:00
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：

华中科技大学同济医学院附属同济医院

Primary sponsor：

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

研究实施负责（组长）单位地址：

武汉市解放大道1095号

Primary sponsor's address：

1095 Jiaofang Road, Wuhan, Hubei, 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)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	国家自然基金会	具体地址：	北京市海淀区双清路83号
Institution hospital：	National Natural Science Foundation of China	Address：	83 Shuangqing Road, Haiding District, Beijing

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：

慢性鼻窦炎并鼻息肉

Target disease：

Chronic rhinosinusitis with nasal polyps

研究疾病代码：

471.9 471.9

Target disease code：

471.9 471.9

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：

4

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

口服糖皮质激素对嗜酸粒细胞性及非嗜酸粒细胞性鼻息肉患者治疗效果的比较

Objectives of Study：

To compare the clinical efficacy of oral glucocorticoid in the treatment of Eosinophilic nasal polyps and Non-eosinophilic nasal polyps.

药物成份或治疗方案详述：

强的松片醋酸泼尼松片

Description for medicine or protocol of treatment in detail：

Prednisone tablet prednisone acetate

纳入标准：

Inclusion criteria

1. Subjects must be at least 18 years of age, of either sex, and of any race;
2. Subjects must have a diagnosis of bilateral nasal polyps at screening and baseline that have recurred after surgical resection or nasal polyps that are grades 3 or 4 in both nares using the polyp scoring system;
3. Subjects must be in good health and free of any clinically significant disease that would interfere with the study schedule or procedures or compromise the subjects' safety;
4. Subjects must be willing to give informed consent and adhere to visit schedules and medication restrictions and agree to perform daily diary entries;
5. Subjects with concurrent asthma must be maintained on no more than 1000 mcg/d beclomethasone dipropionate or the equivalent;
6. Nonpregnant women of childbearing potential must use a medically acceptable, adequate form of birth control. This includes: 
(1) hormonal contraceptive as prescribed by a physician (eg, oral combined, hormonal implant, depot injectable);
(2) medically prescribed intra uterine device (IUD);
(3) condom in combination with a spermicide;
(4) monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. They must have started this birth control method at least 3 months before screening (with the exception of condom in combination with a spermicide), and they must agree to continue its use for the duration of the study. Women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study.
Women who are surgically sterilized or are at least 1 year postmenopausal are considered not to be of childbearing potential.
However, all female subjects must have a urine pregnancy test before treatment, which must be negative.
Male subjects must agree to use an adequate form of birth control for the duration of the study. They must either agree to use a condom with spermicide or agree to have sexual relations only with women using medically acceptable forms of birth control as described.

排除标准：

（1）妊娠或哺乳期妇女。
（2）受试者有囊性纤维化，先天性纤毛运动障碍，非侵袭性真菌球和侵袭性真菌病，系统性血管炎和肉芽肿性疾病，肿瘤患者，免疫缺陷，过敏性真菌性鼻窦炎。
（3）受试者对糖皮质激素过敏者。
（4）受试者长期通过鼻、口腔吸入或者系统给药途径，接受糖皮质激素、大环内酯类药物、多西环素、白三烯抑制剂、抗组胺类药物及茶碱类药物其中任何一种药物治疗；或其它治疗方式，例如鼻腔冲洗、脱敏治疗等。或最近3个月接受上述药物全身治疗，最近1个月接受上述药物局部治疗。
（5）受试者正罹患上呼吸道感染。
（6）临床上患有严重的代谢、心血管、免疫、神经、血液、消化、脑血管或呼吸系统疾病，或研究员认为任何干扰研究结果的评估或影响受试者安全的疾病。
（7）目前正在参加其他临床研究或30天以内参加过其他临床研究者，或直接参与此研究的工作人员。
（8）具有精神病史、对抗性格、不良动机、多疑或其他情感或智力问题，可能影响参与研究的知情有效性。
（9）新近行各类手术或患有活动性消化性溃疡、抗生素不能控制的感染、严重高血压、糖尿病、白内障、青光眼等不适合应用糖皮质激素的疾病的患者。
（10）症状严重或症状不能忍受之患者。
（11）研究者认为不适合入选者。

Exclusion criteria：

1. Women who is pregnant, breast-feeding, or premenarcheal;
2. Subjects who have required a burst of oral corticosteroids within the 3 months before screening are excluded from the study;
3. Subjects with systemic fungoid infections, known allergic reaction on methylprednisolone or tetracyclines, hypertension, diabetes (type 1 and 2), glaucoma, tuberculosis, herpes infection, or zona ophtalmica are excluded, and children are excluded.
Patients with antineutrophil cytoplasmic antibodies such as patients with Wegener granulomatosis, Churg-Strauss syndrome, and microscopic polyangiitis are excluded on the basis of the systemic involvement, nasal crusting, vasculitis, and septal perforation;
4. Subjects with acute sinusitis or concurrent nasal infection or subjects who have had a nasal or upper respiratory tract infection
within 2 weeks of the screening visit are excluded;
5. Subjects with cystic fibrosis, primary ciliary dysfunction or Kartagener syndrome by history are excluded;
6. Subjects must not have been diagnosed with a parasitic infection;
7. Subjects must not be known to be HIV-positive or positive to hepatitis B surface antigen or C antibodies. Testing will not be done at screening;
8. Subjects must not have had an acute asthmatic attack requiring admission to a hospital (excluding emergency department visits that resulted in direct discharge without hospitalization) within the 4 weeks before screening;
9. Subjects must not have received immunotherapy within the previous 3 months.

研究实施时间：

Study execute time：

从 From 2011-01-01 00:00:00至 To 2015-01-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2011-01-01 00:00:00 至 To 2014-12-31 00:00:00

干预措施：

Interventions：

组别：	A组	样本量：	50
Group：	Group A	Sample size：	50
干预措施：	口服强的松片（5mgx65片，疗程20天）	干预措施代码：
Intervention：	Oral prednisolone tablets (65x5mg in 20 days)	Intervention code：

组别：	B组	样本量：	50
Group：	Group B	Sample size：	50
干预措施：	口服安慰剂（用法同上）	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)：	湖北	市(区县)：
Country：	China	Province：	Hubei	City：
单位(医院)：	同济医院	单位级别：	三甲医院
Institution hospital：	Tongji Hospital	Level of the institution：	Tertiary A hospital

测量指标：

Outcomes：

指标中文名：	VAS症状视觉评分、Lanza-Kennedy鼻内镜检查评分	指标类型：	主要指标
Outcome：	VAS score, Lanza-Kennedy nasal endoscopy score	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：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	65	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）：

随机数字表

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

randomization digit table

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：	医生和病人是
Blinding：	Doctor and patient: Blinding
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing
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）：	华中科技大学同济医学院附属同济医院耳鼻咽喉-头颈外科
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Department of Otorhinolaryngology-head and Neck Surgery, Tongji Hospital of Tongji Medical College
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：	华中科技大学同济医学院卫生统计学系及华中科技大学同济医学院附属同济医院耳鼻咽喉-头颈外科
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Health Statistics of Tongji Medical College
数据与安全监察委员会： Data and Safety Monitoring Committee：
注册人： Name of Registration：	2015-07-11 15:25:50