ChiCTR2400082672 版本V1.5 版本创建时间2025/10/17 14:27:06 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：

 ChiCTR2400082672 

最近更新日期：

Date of Last Refreshed on：

 2024-11-20 16:52:16 

注册时间：

Date of Registration：

 2024-04-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

多模态肺功能诊断模型的建立与其在不完全可逆性气流受限的支气管哮喘和慢性阻塞性肺疾病鉴别中的作用

Public title：

Establishment of a Multimodal Respiratory Function Diagnostic Model and its Role in the Differential Diagnosis of Bronchial Asthma and Chronic Obstructive Pulmonary Disease with Incomplete Reversible Airflow Limitation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

多模态肺功能诊断模型的建立与其在不完全可逆性气流受限的支气管哮喘和慢性阻塞性肺疾病鉴别中的作用

Scientific title：

Establishment of a Multimodal Respiratory Function Diagnostic Model and its Role in the Differential Diagnosis of Bronchial Asthma and Chronic Obstructive Pulmonary Disease with Incomplete Reversible Airflow Limitation

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：

李鹏 

研究负责人：

李鹏 

Applicant：

Li Peng 

Study leader：

Li Peng 

申请注册联系人电话：

Applicant telephone：

 +86 632 328 8026

研究负责人电话：

Study leader's
telephone：

+86 632 328 8026

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：

 slyylh@sina.com

研究负责人电子邮件：

Study leader's E-mail：

 slyylh@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：

枣庄市市中区龙头中路41号

研究负责人通讯地址：

枣庄市市中区龙头中路41号

Applicant address：

No. 41 Longtou Middle Road, Shizhong District, Zaozhuang City

Study leader's address：

No. 41 Longtou Middle Road, Shizhong District, Zaozhuang City

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：

枣庄市立医院

Applicant's institution：

Zaozhuang Municipal Hospital

研究负责人所在单位：

枣庄市立医院

Affiliation of the Leader：

Zaozhuang Municipal Hospital

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：

 zzslyykyll2023121208; zzslyykyll20241101025

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：

枣庄市立医院医学伦理委员会

Name of the ethic committee：

The Medical Ethics Committee of Zaozhuang Municipal Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-12-12 00:00:00

伦理委员会联系人：

韩帅

Contact Name of the ethic committee：

Han Shuai

伦理委员会联系地址：

枣庄市市中区龙头中路41号

Contact Address of the ethic committee：

No. 41 Longtou Middle Road, Shizhong District, Zaozhuang City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 0632-3288 019

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：

枣庄市立医院

Primary sponsor：

Zaozhuang Municipal Hospital

研究实施负责（组长）单位地址：

山东省枣庄市市中区龙头中路41号

Primary sponsor's address：

No. 41 Longtou Middle Road, Shizhong District, Zaozhuang City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东

市(区县)：

枣庄

Country：

China

Province：

Shandong

City：

ZaoZhuang

单位(医院)：

枣庄市立医院

具体地址：

枣庄市市中区龙头中路41号

Institution
hospital：

Zaozhuang Municipal Hospital

Address：

No. 41 Longtou Middle Road, Shizhong District, Zaozhuang City

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

支气管哮喘和慢性阻塞性肺疾病  

Target disease：

Asthma and chronic obstructive pulmonary disease

研究疾病代码：

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

诊断试验诊断准确性 

Study design：

Diagnostic test for accuracy 

研究目的：

本回顾性分析旨在发掘新的指标将不完全可逆性气流受限的支气管哮喘和慢性阻塞性肺疾病鉴别。  

Objectives of Study：

The aim of this retrospective analysis is to explore new indicators for differentiating bronchial asthma from chronic obstructive pulmonary disease (COPD) with incomplete reversible airflow limitation.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

训练样本的选择 支气管哮喘患者的纳入标准：①吸入支气管舒张剂后FEV1/FVC＜70%。②支气管哮喘诊断史。③符合《Global Initiative for Asthma》关于支气管哮喘的诊断标准，Ⅰ.反复发作喘息、气急、胸闷、咳嗽，多与接触变应原、冷空气、物理、化学性刺激、病毒性上呼吸道感染、运动等有关;Ⅱ.发作时在双肺可闻及散在或弥散性，以呼气相为主的哮鸣音，呼气相延长;Ⅲ.上述症状可经治疗缓解或者自行缓解。Ⅳ.可变气流受限的客观检查：①支气管激发试验或者运动试验阳性；②支气管舒张试验阳性；③PEF昼夜变异率＞10%,或者PEF周变异率＞20%。符合上述症状和体征，同时具备气流受限客观检查中的任一条，并除外其他疾病所引起的喘息、气急、胸闷和咳嗽，可以诊断为支气管哮喘。 慢性阻碍性肺疾病患者的纳入标准：①具有慢性阻塞性肺疾病既往诊断历史。②符合《Global Initiative for Chronic Obstructive Lung Disease》关于慢性阻塞性肺疾病的诊断标准，有吸烟、接触职业粉尘和化学物质等危险因素暴露史，常年咳嗽、咳痰、呼吸困难，吸入支气管舒张剂后FEV1/FVC小于70%。 验证样本的选择 既往已经明确诊断为支气管哮喘或者慢性阻塞性肺疾病的患者作为验证样本，而晚期他们由于气道重构而呈现不完全可逆性气流受限变得难以鉴别。

Inclusion criteria

Selection of Training Samples We included patients with asthma based on the following criteria:1.Postbronchodilator FEV1/FVC <0.7. 2.Documented history of asthma. 3.fulfillment of the criteria defined by the Global Initiative for Asthma: (I) repeated attacks of wheezing, shortness of breath, chest tightness, cough, and relevance to allergens, cold air, physical and chemical stimulation, infection of the upper respiratory tract, exercise, etc.; (II) when an attack occurs, scattered or diffuse wheezing of the expiratory phase can be heard with a prolonged expiratory phase; (III) these symptoms can be relieved by treatment or resolve spontaneously; (IV) objective evidences of variable airflow limitation: (a) positive bronchial provocation test or exercise test; (b) positive bronchodilation test; (c) variation of daily peak expiratory flow (PEF)>10%, or variation of weekly PEF>20%. The patients, according to I-Ⅲ, and meeting at least one of Ⅳ items, excluding other conditions causing wheezing, shortness, chest tightness, or cough, can be diagnosed with asthma. The inclusion criteria for patients with COPD were as follows: 1.Documented history of COPD.2.participants were defined as having COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines, with a history of smoking, exposure to occupational dust and chemical substances, perennial cough, expectoration, dyspnea, and a post-bronchodilator FEV1/FVC <70%. Selection of validation samples Patients previously diagnosed with asthma or COPD were included as validation samples, which were crucial for distinguishing between the two conditions when incomplete reversible airflow limitation is present due to airway remodeling.

排除标准：

支气管哮喘患者的排除标准：①排除支气管扩张、肺结核纤维化病变、严重的间质性肺疾病、弥漫性泛细支气管炎、闭塞性细支气管炎。②通过胸部CT排除大气道阻塞的患者。 慢性阻塞性肺疾病患者的排除标准：①排除支气管扩张、肺结核纤维化病变、严重的间质性肺疾病、弥漫性泛细支气管炎、闭塞性细支气管炎。②中心气道塌陷的患者也需要通过胸部CT检查排除。 两类患者均需排除支气管哮喘-慢阻肺重叠综合征（Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome ACOS）存在的可能, ACOS病人必须具备主要标准和一个次要标准。三个主要标准是：（1）持续性气流受限（吸入支气管舒张剂后FEV1/FVC小于70%或者小于正常值下限）、年龄超过40岁。（2）至少吸烟10包/年或者等量的生物燃料。（3）40岁以前有可记录的哮喘历史，或者吸入支气管舒张剂后FEV1改善超过400ml。次要标准包括：（1）有特异反应性鼻炎或者过敏性鼻炎。（2）在2次或者多次随访时吸入支气管舒张剂后FEV1改善率超过12%且大于200ml。（3）外周血嗜酸性粒细胞超过200/ml。

Exclusion criteria：

Exclusion criteria for patients with bronchial asthma: (a)the presence of bronchiectasis, fibrotic lesions caused by pulmonary tuberculosis, interstitial lung disease, diffuse bronchiolitis, or bronchiolitis obliterans, and (b) large airway obstructions using chest computed tomography (CT). The exclusion criteria for patients with COPD were as follows: (a) the presence of bronchiectasis, fibrotic lesions caused by pulmonary tuberculosis, interstitial lung disease, diffuse bronchiolitis, or bronchiolitis obliterans, and (b) evidence of collapsed central airways using chest computed tomography (CT). Patients with asthma–chronic obstructive pulmonary disease overlap syndrome (ACOS) were excluded from the study. Such patients must meet all major criteria and at least one minor criterion. The three major criteria include (a) persistent airflow limitation (FEV1/FVC <70% or less than the lower limit of normal post-bronchodilator inhalation) and age >40 years, (b) a smoking index of at least 10 pack-years or equivalent exposure to biofuels, and (c) a documented history of asthma with onset before age 40 or an increase in FEV1 of >400 mL post-bronchodilator. The minor criteria include (a) a documented history of atopic or allergic rhinitis, (b) an increase in FEV1 by >12% and >200 mL post-bronchodilator inhalation on at least two separate visits, and (c) peripheral blood eosinophil counts >200 cells/μL.

研究实施时间：

Study execute time：

从 From 2024-11-20 00:00:00至 To 2025-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-11-20 00:00:00 至 To 2025-02-01 00:00:00

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

既往诊断结果； 《Global Initiative for Asthma》关于支气管哮喘的诊断标准，Ⅰ.反复发作喘息、气急、胸闷、咳嗽，多与接触变应原、冷空气、物理、化学性刺激、病毒性上呼吸道感染、运动等有关;Ⅱ.发作时在双肺可闻及散在或弥散性，以呼气相为主的哮鸣音，呼气相延长;Ⅲ.上述症状可经治疗缓解或者自行缓解。Ⅳ.可变气流受限的客观检查：①支气管激发试验或者运动试验阳性；②支气管舒张试验阳性；③PEF昼夜变异率＞10%,或者PEF周变异率＞20%。符合上述症状和体征，同时具备气流受限客观检查中的任一条，并除外其他疾病所引起的喘息、气急、胸闷和咳嗽，可以诊断为支气管哮喘。 《Global Initiative for Chronic Obstructive Lung Disease》关于慢性阻塞性肺疾病的诊断标准，根据吸烟、接触职业粉尘和化学物质等高危因素，常年咳嗽、咳痰、呼吸困难等症状，吸入支气管舒张剂后FEV1/FVC＜70%。

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Previous diagnostic results; The diagnostic criteria for bronchial asthma in the Global Initiative for Asthma: (I) repeated attacks of wheezing, shortness of breath, chest tightness, cough, and relevance to allergens, cold air, physical and chemical stimulation, infection of the upper respiratory tract, exercise, etc.; (II) when an attack occurs, scattered or diffuse wheezing of the expiratory phase can be heard with a prolonged expiratory phase; (III) these symptoms can be relieved by treatment or resolve spontaneously; (IV) objective evidences of variable airflow limitation: (a) positive bronchial provocation test or exercise test; (b) positive bronchodilation test; (c) variation of daily peak expiratory flow (PEF)>10%, or variation of weekly PEF>20%. The patients, according to I-Ⅲ, and meeting at least one of Ⅳ items, excluding other conditions causing wheezing, shortness, chest tightness, or cough, can be diagnosed with asthma. The diagnostic criteria for chronic obstructive pulmonary disease in the Global Initiative for Chronic Obstructive Lung Disease, history of smoking, exposure to occupational dust and chemical substances, perennial cough, expectoration, dyspnea, and FEV1/FVC less than 70% after inhalation of bronchodilators.

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

流速-容积曲线中有无典型凹陷型图形，FVC/Pre%：用力肺活量占预计值百分比，FEV1/pre%：第一秒用力呼气容积占预计值百分比，FEV1/FVC占预计值%：一秒率占预计值百分比，PEF/pre%：呼气峰流速占预计值百分比，MEF75/预%：75%用力肺活量的呼气流量占预计值百分比，MEF50/预%：50%用力肺活量的呼气流量占预计值百分比，MEF25/预%：25%用力肺活量的流量占预计值百分比，MEF25-75/预%：最大呼气中期流量占预期值百分比； 多模态肺功能诊断模型；

Index test:

Presence or absence of the typical concave patterns in the F-V curve, FVC/pre%: forced vital capacity to the expected value, FEV1/pre%: forced expiratory volume in one second to the expected value, PEF/pre%: the peak expiratory flow rate to the expected value, MEF75/pre%: maximum expiratory flow at 75% of forced vital capacity to the expected value, MEF50/pre%: maximum expiratory flow at 50% of forced vital capacity to the expected value, MEF25/pre%: maximum expiratory flow at 25% of forced vital capacity to the expected value, MEF25-75/pre%: maximal mid-expiratory flow to the expected value; Multimodal Respiratory Function Diagnostic Model;

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

支气管哮喘患者和慢性阻塞性肺疾病患者

例数:

Sample size:

159

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients with bronchial asthma or COPD

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

无

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

None

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

  

Country：

China

Province：

Shandong

City：

单位(医院)：

 枣庄市立医院 

单位级别：

 三级甲等 

Institution
hospital：

Zaozhuang Municipal Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

肺功能指标

指标类型：

主要指标

Outcome：

Pulmonary function indicators

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

ROC曲线

指标类型：

主要指标

Outcome：

ROC curve

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

AUC

指标类型：

主要指标

Outcome：

AUC

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：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 14 岁 years
最大 Max age 99 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）：

不适用

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

N/A

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：

Blinding：

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）：

不共享

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

No shared

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：

无

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

None

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：

  2024-04-03 10:56:59