ChiCTR2600126986 版本V1.1 版本创建时间2026/06/22 15:38:04 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:

ChiCTR2600126986 

最近更新日期:

Date of Last Refreshed on:

2026-06-22 15:37:38 

注册时间:

Date of Registration:

2026-06-22 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

一项评价家用经鼻高流量氧疗在特发性肺纤维化和纤维化型间质性肺疾病患者中的有效性和安全性的24周、随机、对照研究

Public title:

A 24-Week, Randomized, Controlled Study Evaluating the Efficacy and Safety of Domiciliary High-Flow Nasal Cannula in Patients with Idiopathic Pulmonary Fibrosis and Fibrotic Interstitial Lung Diseases

注册题目简写:

English Acronym:

研究课题的正式科学名称:

一项评价家用经鼻高流量氧疗在特发性肺纤维化和纤维化型间质性肺疾病患者中的有效性和安全性的24周、随机、对照研究

Scientific title:

A 24-Week, Randomized, Controlled Study Evaluating the Efficacy and Safety of Domiciliary High-Flow Nasal Cannula in Patients with Idiopathic Pulmonary Fibrosis and Fibrotic Interstitial Lung Diseases

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:

舒适 

研究负责人:

代华平 

Applicant:

Shi Shu 

Study leader:

Huaping Dai 

申请注册联系人电话:

Applicant telephone:

+86 13240931333

研究负责人电话:

Study leader's
telephone:

+86 10 84206408

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:

ss_hit@126.com

研究负责人电子邮件:

Study leader's E-mail:

daihuaping@sina.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:

北京市朝阳区樱花园东街2号

研究负责人通讯地址:

北京市朝阳区樱花园东街2号

Applicant address:

No. 2, East Yinghuayuan Street, Chaoyang District, Beijing

Study leader's address:

No. 2, East Yinghuayuan Street, Chaoyang District, Beijing

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:

中日友好医院

Applicant's institution:

China-Japan Friendship Hospital

研究负责人所在单位:

中日友好医院

Affiliation of the Leader:

China-Japan Friendship Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2024-KY-429-1; 2024-KY-429-3; 2024-KY-429-4

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:

中日友好医院临床研究伦理委员会

Name of the ethic committee:

Clinical Research Ethics Committee of China-Japan Friendship Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2025-01-02 00:00:00

伦理委员会联系人:

闫旭

Contact Name of the ethic committee:

Xu Yan

伦理委员会联系地址:

北京市朝阳区樱花园东街2号

Contact Address of the ethic committee:

No. 2, East Yinghuayuan Street, Chaoyang District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 84206250

伦理委员会联系人邮箱:

Contact email of the ethic committee:

zryyec@126.com

研究实施负责(组长)单位:

中日友好医院

Primary sponsor:

China-Japan Friendship Hospital

研究实施负责(组长)单位地址:

北京市朝阳区樱花园东街2号

Primary sponsor's address:

No. 2, East Yinghuayuan Street, Chaoyang District, Beijing

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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中日友好医院

具体地址:

北京市朝阳区樱花园东街2号

Institution
hospital:

China-Japan Friendship Hospital

Address:

No. 2, East Yinghuayuan Street, Chaoyang District, Beijing

经费或物资来源:

自筹

Source(s) of funding:

Self-funded

研究疾病:

特发性肺纤维化、各种类型间质性肺炎导致的纤维化型间质性肺疾病  

Target disease:

Idiopathic pulmonary fibrosis and fibrotic interstitial lung disease caused by various types of interstitial pneumonia

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:

其它 

Study phase:

N/A

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

与传统鼻导管吸氧相比,评估家用经鼻高流量氧疗联合鼻导管吸氧在间质性肺炎患者中的有效性及安全性。  

Objectives of Study:

Evaluate the effectiveness and safety of home-based high-flow nasal cannula oxygen therapy combined with conventional nasal cannula oxygen, compared to traditional nasal cannula oxygen alone, in patients with interstitial pneumonia.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

1.诊断为特发性肺纤维化或者纤维化型间质性肺疾病稳定期患者; 2.休息状态,出现中度低氧血症患者(SpO2 89%-93%),或中度运动诱发低氧血症患者(Spo2>=80% >=5 分钟,且 <90% >=10 秒); 3.男性或女性患者>=18 岁; 4.吸烟者,需戒烟3个月以上; 5.如果患者应用激素,剂量<=3片/日持续1个月以上。

Inclusion criteria

1. Patients diagnosed with idiopathic pulmonary fibrosis or fibrotic interstitial lung disease in a stable phase; 2. Patients with moderate hypoxemia at rest (SpO2 89%-93%) or moderate exercise-induced hypoxemia (SpO2 >=80% for >=5 minutes, and <90% for >=10 seconds); 3. Male or female patients aged 18 or older; 4. Smokers who have quit for more than 3 months; 5. If the patient is on steroids, the dose should be <=3 tablets/day for more than 1 month.

排除标准:

1.经治医生认为患者依从性较差; 2.无法完成肺功能检查或研究相关量表评估(如肺功能很差、脑卒中遗留明显肢体活动障碍、认知障碍等); 3.鼻腔严重堵塞,或无法耐受HFNC; 4.研究者评估基础状态较差,无法参加后续3个月、6个月随访; 5.筛选前1 个月内和/或筛选期间间质性肺炎急性加重; 6.筛选前1个月急性肺栓塞; 7.未控制的传染病,包括活动性肺结核、活动性乙肝、丙肝、HIV 、梅毒; 8.既往或现在有恶性肿瘤的受试者(除外在进入研究筛选前 5 年已达到完全缓解、不需其他治疗方案或预期在研究期间不需要继续治疗的受试者); 9.筛选前 3 个月内发生过心肌梗死、心绞痛、经皮冠状动脉腔内血管成形术、冠状动脉搭桥术、心力衰竭(纽约心脏病协会心功能分级>II 级)、短暂性脑缺血发作、脑梗塞、脑出血或蛛网膜下腔出血; 10.经研究者判断不适合参与本研究。

Exclusion criteria:

1.Patients deemed by the treating physician to have poor adherence.
2.Inability to complete pulmonary function tests or study-related questionnaire assessments (e.g., due to severe pulmonary impairment, significant motor impairment from prior stroke, cognitive impairment).
3.Severe nasal obstruction or inability to tolerate high-flow nasal cannula (HFNC) therapy.
4.Investigator assessment of poor baseline condition precluding participation in follow-up visits at 3 and 6 months.
5.Acute exacerbation of interstitial pneumonia within 1 month prior to screening and/or during the screening period.
6.Acute pulmonary embolism within 1 month prior to screening.
7.Uncontrolled infectious diseases, including active tuberculosis, active hepatitis B or C, HIV infection, or syphilis.
8.History or current diagnosis of malignancy, except for subjects who have achieved complete remission >5 years prior to screening and require no further active treatment or are not expected to require treatment during the study period.
9.History of myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, heart failure (New?York Heart Association functional class?>?II), transient ischemic attack, cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage within the preceding 3?months;
10.Considered by the investigator to be unsuitable for participation in this study.

研究实施时间:

Study execute time:

From 2025-06-04 00:00:00 To 2027-07-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-06-04 00:00:00 To 2026-12-01 00:00:00

干预措施:

Interventions:

组别:

对照组

样本量:

178

Group:

Control group

Sample size:

干预措施:

常规鼻导管吸氧

干预措施代码:

Intervention:

Standard nasal cannula oxygen

Intervention code:

组别:

试验组

样本量:

178

Group:

Experimental group

Sample size:

干预措施:

居家经鼻高流量吸氧

干预措施代码:

Intervention:

Domiciliary High flow nasal cannula

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

中日友好医院 

单位级别:

三级甲等 

Institution
hospital:

China-Japan Friendship Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

荆州市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Jingzhou Central Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山东省 

市(区县):

 

Country:

China

Province:

Shandong

City:

单位(医院):

潍坊市第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Weifang No.2 People's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖南省 

市(区县):

 

Country:

China

Province:

Hunan

City:

单位(医院):

中南大学湘雅三医院 

单位级别:

三级甲等 

Institution
hospital:

The Third Xiangya Hospital of Central South University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

上海市 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三级甲等 

Institution
hospital:

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京市昌平区医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Changping Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京友谊医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Friendship Hospital, Capital Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河南省 

市(区县):

 

Country:

China

Province:

Henan

City:

单位(医院):

河南省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Henan Provincial People's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三级甲等 

Institution
hospital:

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

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖南省 

市(区县):

 

Country:

China

Province:

Hunan

City:

单位(医院):

中南大学湘雅二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Xiangya Hospital, Central South University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

湖北省中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Hubei Provincial Hospital of Integrated Chinese and Western Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

安徽省 

市(区县):

 

Country:

China

Province:

Anhui

City:

单位(医院):

中国科学技术大学附属第一医院(安徽省立医院) 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

安徽省 

市(区县):

 

Country:

China

Province:

Anhui

City:

单位(医院):

安徽医科大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Anhui Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

武汉市中心医院 

单位级别:

三级甲等 

Institution
hospital:

The Central Hospital of Wuhan

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山东省 

市(区县):

 

Country:

China

Province:

Shandong

City:

单位(医院):

青岛市市立医院 

单位级别:

三级甲等 

Institution
hospital:

Qingdao Municipal Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

上海市 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属中山医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongshan Hospital, Fudan University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山东省 

市(区县):

 

Country:

China

Province:

Shandong

City:

单位(医院):

山东大学齐鲁医院 

单位级别:

三级甲等 

Institution
hospital:

Qilu Hospital of Shandong University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖南省 

市(区县):

 

Country:

China

Province:

Hunan

City:

单位(医院):

中南大学湘雅医院 

单位级别:

三级甲等 

Institution
hospital:

Xiangya Hospital Central South University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京清华长庚医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Tsinghua Changgung Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

武汉大学中南医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongnan Hospital of Wuhan University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

武汉市第六医院江汉大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Jianghan University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京安贞医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Anzhen Hospital, Capital Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

华中科技大学同济医学院附属协和医院 

单位级别:

三级甲等 

Institution
hospital:

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

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军总医院 

单位级别:

三级甲等 

Institution
hospital:

Chinese People's Liberation Army General Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

上海市 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市肺科医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Pulmonary Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山东省 

市(区县):

 

Country:

China

Province:

Shandong

City:

单位(医院):

青岛大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Qingdao University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

湖北省中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Hubei Provincial Hospital of Integrated Chinese and Western Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

武汉大学中南医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongnan Hospital of Wuhan University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军空军特色医学中心 

单位级别:

三级甲等 

Institution
hospital:

Chinese People's Liberation Army Air Force Specialty Medical Center

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京市 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学东直门医院 

单位级别:

三级甲等 

Institution
hospital:

Dongzhimen Hospital, Beijing University of Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河南省 

市(区县):

 

Country:

China

Province:

Henan

City:

单位(医院):

郑州大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Zhengzhou University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

上海市 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市胸科医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Chest Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

6分钟步行试验距离较基线变化

指标类型:

主要指标

Outcome:

Walking Distance of 6 minute walk

Type:

Primary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

Measure method:

指标中文名:

睡眠质量问卷评分(匹兹堡睡眠质量指数量表)

指标类型:

次要指标

Outcome:

Pittsburgh Sleep Quality Index Score

Type:

Secondary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

Measure method:

指标中文名:

死亡例数

指标类型:

次要指标

Outcome:

deaths

Type:

Secondary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

Measure method:

指标中文名:

DLCO SB(血红蛋白校正值)占预计值百分比较基线绝对变化

指标类型:

次要指标

Outcome:

the change of DLCO SB (Hb corrected) per predicted from baseline

Type:

Secondary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

Measure method:

指标中文名:

肺移植例数

指标类型:

次要指标

Outcome:

number of patients undergoing lung transplant

Type:

Secondary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

Measure method:

指标中文名:

间质性肺炎急性加重次数、首次发生急性加重时间(天数)

指标类型:

次要指标

Outcome:

how many times of AE-ILD;days to the first AE-ILD

Type:

Secondary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

Measure method:

指标中文名:

胸部HRCT纤维化病变较基线变化

指标类型:

次要指标

Outcome:

Change of fibrotic lesion from baseline on HRCT

Type:

Secondary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

Measure method:

指标中文名:

肺动脉高压情况(新发肺动脉高压例数、肺动脉压力较基线绝对值变化)

指标类型:

次要指标

Outcome:

pulmonary hypertension, including number of patients with new onset PH, and PH change from baseline

Type:

Secondary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

Measure method:

指标中文名:

焦虑抑郁量表评分

指标类型:

次要指标

Outcome:

HAD score

Type:

Secondary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

Measure method:

指标中文名:

6分钟步行试验血氧饱和度恢复至正常时间

指标类型:

次要指标

Outcome:

Time to normal oxygen saturation after 6 minute walking test

Type:

Secondary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

Measure method:

指标中文名:

生活质量,圣乔治呼吸困难问卷评分(SQRG)

指标类型:

次要指标

Outcome:

life quality, St. George's Dyspnea Questionnaire

Type:

Secondary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

Measure method:

指标中文名:

FVC占预计值百分比较基线绝对变化

指标类型:

次要指标

Outcome:

the absolute change of FVC per predicted from baseline

Type:

Secondary indicator

测量时间点:

6个月

测量方法:

Measure time point of outcome:

6 months

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

由专业统计师通过计算机产生随机数

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

The computer generates random numbers

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

开放标签

Blinding:

Open-label

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):

邮件联系研究者

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

Email the researcher

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2026-06-22 15:36:25