ChiCTR2400082672 版本V1.0 版本创建时间2024/04/03 10:57:03 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：

 2024-04-03 10:56:59 

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

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：

 +86 159 6673 6696

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： 支气管哮喘患者的纳入标准：符合《Global strategy for Asthma management and prevention》支气管哮喘诊断标准：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.除外其他疾病引起的喘息、气急、胸闷、咳嗽。Ⅵ.临床表现不典型者应该有下列三项中至少一项阳性：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；③昼夜PEF变异率≥20%。符合I-Ⅳ条或者Ⅳ、Ⅵ条者可以诊断为支气管哮喘。 慢性阻塞性肺疾病患者的纳入标准：符合《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%。 验证样本： 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

Training samples: Inclusive criterion for patients with bronchial asthma: participants were defined as patients with bronchial asthma according to Global Strategy for Asthma Management and Prevention, I. Repeated attacks of wheezing, shortness of breath, chest tightness, cough, and relevance to allergens, cold air, physical and chemical stimulation, the infection of upper respiratory track, exercise and so on; Ⅱ. When the attack occurs, scattered or diffuse wheezing of expiratory phase can be heard with expiratory phase prolonged; Ⅲ. These symptoms can be relieved by treatment or resolve spontaneously; Ⅳ. Exclude other diseases caused by wheezing, shortness, chest tightness, cough;Ⅵ. Patients with atypical clinical manifestations shall have at least one of the following items :①bronchial provocation test or exercise test display positive;②bronchodilation test is positive;③variation of daily PEF≥20%. The patients according to I-Ⅳ or Ⅳ,ⅤI can be diagnosed with bronchial asthma. Inclusive criterion for patients with COPD: participants were defined as patients with COPD according to 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 bronchodilator. Validation samples: Patients who have been previously diagnosed with bronchial asthma or chronic obstructive pulmonary disease are used as validation samples, but in the later stages, they present with incomplete reversible airflow restriction due to airway remodeling, making it difficult to distinguish.

排除标准：

训练样本： 支气管哮喘患者排除标准：①曾使用长效毒蕈碱拮抗剂（the long-acting muscarinic antagonist LAMA）、长效?激动剂（Long-acting ? agonists LABA）、吸入型糖皮质激素（inhaled corticosteroids ICS）的患者应当被排除。②吸入支气管舒张剂后FEV1/FVC＜70%的患者被排除，以确保所选择的支气管哮喘患者中没有混入慢性阻塞性肺疾病患者。③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排除标准：①曾使用长效毒蕈碱拮抗剂（LAMA）、长效β受体激动剂（LABA）、吸入型糖皮质激素（ICS）的患者应当被排除在外。②有支气管舒张试验阳性的患者也被排除在外，确保慢性阻塞性肺疾病患者中没有混入支气管哮喘患者。③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。④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：

Training samples: Exclusive criterion: ①Patients who had used a long-acting muscarinic antagonists (LAMA), a long-acting β agonists (LABA), and inhaled corticosteroids (ICS) should be excluded.②Patients with FEV1/FVC<70% after bronchodilator inhalation were excluded to ensure that patients suffering from bronchial asthma were not mixed with patients with COPD. ③Patients with large airway obstruction should also be excluded by chest CT (computer tomography). Exclusive criterion:①Patients who had used a long-acting muscarinic antagonist (LAMA), a long-acting β agonist (LABA), and inhaled corticosteroids (ICS) should be excluded.②Patients with a positive bronchodilation test were also excluded, ensuring that patients with bronchial asthma didn’t include patients with COPD. ③Bronchiectasis, fibrotic lesions caused by pulmonary tuberculosis, interstitial lung disease, diffuse bronchiolitis, and bronchiolitis obliterans were excluded.④Patients with a collapsed central airway also needed to be excluded by chest CT. Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome (ACOS) was excluded, Patients defined as ACOS must have all major criteria and at least a minor criterion. The three major criteria include items as follow: (1) persistent airflow limitation (FEV1/FVC<70% or less than the lower limit of normal after bronchodilator inhalation) and age more than 40 years old. (2) smoking index of at least 10 packs/year or equivalent exposure of biofuels. A documented history of asthma aged under 40 years old or an increase in FEV1 of more than 400ml postbronchodilator. Minor criteria include items as follow: (1) documented history of atopic or allergic rhinitis; (2) FEV1 increases by more than 12% and more than 200ml after bronchodilator inhalation at least 2 visits. (3) peripheral blood eosinophil counts more than 200 cells/ml.

研究实施时间：

Study execute time：

从 From 2024-04-10 00:00:00至 To 2024-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-04-10 00:00:00 至 To 2024-06-30 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 Strategy for Asthma Management and Prevention》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.除外其他疾病引起的喘息、气急、胸闷、咳嗽;Ⅵ.临床表现不典型者应该有下列三项中至少一项阳性：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；③昼夜PEF变异率≥20%。符合Ⅰ-Ⅳ条或者Ⅳ、Ⅵ条者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 Strategy for Asthma Management and Prevention, I. Repeated attacks of wheezing, shortness of breath, chest tightness, cough, and relevance to allergens, cold air, physical and chemical stimulation, the infection of upper respiratory track, exercise and so on; Ⅱ. When the attack occurs, scattered or diffuse wheezing of expiratory phase can be heard with expiratory phase prolonged; Ⅲ. These symptoms can be relieved by treatment or resolve spontaneously; Ⅳ. Exclude other diseases caused by wheezing, shortness, chest tightness, cough;Ⅵ. Patients with atypical clinical manifestations shall have at least one of the following items :①bronchial provocation test or exercise test display positive;②bronchodilation test is positive;③variation of daily PEF≥20%. The patients according to I-Ⅳ or Ⅳ, ⅤIcan be diagnosed with bronchial 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%：最大呼气中期流量至预期值； 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:

146

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：

 三级甲等医院 

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 15 岁 years
最大 Max age 88 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