简体中文|English
Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

Evaluation of the efficacy of air quality warning in stable intervention in patients with chronic obstructive pulmonary disease (COPD) : a prospective randomized controlled study

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注册号：

Registration number：

ChiCTR2600116479 

最近更新日期：

Date of Last Refreshed on：

2026-01-11 18:54:39 

注册时间：

Date of Registration：

2026-01-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

空气质量预警应用在慢性阻塞性肺疾病（COPD）患者稳定期干预效果的评估：一项前瞻性随机对照研究

Public title：

Evaluation of the efficacy of air quality warning in stable intervention in patients with chronic obstructive pulmonary disease (COPD) : a prospective randomized controlled study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

空气质量预警应用在慢性阻塞性肺疾病（COPD）患者稳定期干预效果的评估：一项前瞻性随机对照研究

Scientific title：

Evaluation of the efficacy of air quality warning in stable intervention in patients with chronic obstructive pulmonary disease (COPD) : a prospective randomized controlled study

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：

张小华 

研究负责人：

张小华 

Applicant：

Zhang Xiaohua 

Study leader：

Xiaohua Zhang 

申请注册联系人电话：

Applicant telephone：

+86 21 2428 9097

研究负责人电话：

Study leader's telephone：

+86 21 2428 9097

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：

747523586@qq.com

研究负责人电子邮件：

Study leader's E-mail：

747523586@qq.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：

上海市闵行区瑞丽路128号

研究负责人通讯地址：

上海市闵行区鹤庆路801号

Applicant address：

No. 128, Ruili Road, Minhang District, Shanghai

Study leader's address：

801 Heqing Road, Minhang District, Shanghai

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：

上海市第五人民医院

Applicant's institution：

Shanghai Fifth People's Hospital

研究负责人所在单位：

上海市第五人民医院

Affiliation of the Leader：

Shanghai Fifth Peoople's Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2024)伦审(111)

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：

复旦大学附属上海市第五人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Shanghai Fifth People's Hospital Affiliated to Fudan University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-12-26 00:00:00

伦理委员会联系人：

钱少霞

Contact Name of the ethic committee：

Qian ShaoXia

伦理委员会联系地址：

上海市闵行区鹤庆路801号

Contact Address of the ethic committee：

801 Heqing Road, Minhang District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 2428 9466

伦理委员会联系人邮箱：

Contact email of the ethic committee：

18656362028@163.com

研究实施负责（组长）单位：

上海市第五人民医院

Primary sponsor：

Shanghai Fifth Peoople's Hospital

研究实施负责（组长）单位地址：

上海市闵行区鹤庆路801号

Primary sponsor's address：

801 Heqing Road, Minhang District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市第五人民医院

具体地址：

上海市闵行区鹤庆路801号

Institution
hospital：

Shanghai Fifth Peoople's Hospital

Address：

801 Heqing Road, Minhang District, Shanghai

经费或物资来源：

2024年闵行区自然科学研究课题

Source(s) of funding：

Minhang District financial assistance funds

Target disease：

Chronic obstructive pulmonary disease

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：

本研究旨在2023年闵行区公共卫生重点学科建设——《环境风险评估与慢性呼吸系统疾病的干预策略及应用研究》构建的慢性呼吸系统疾病环境健康风险评估的平台基础上，深入探索空气预警应用对COPD人群的干预效果。通过在闵行区江川街道、颛桥镇和马桥镇开展的一项前瞻性随机对照研究，采用社区问卷及肺功能检测掌握横断面资料，根据入组标准将患者随机分配到三组（对照组、宣传教育干预、空气质量预警干预），对其开展长达1年的干预，评估不同管理模式对COPD患者的影响。本研究与“健康地球、健康人类”的时代主题密切相关，预期研究成果不仅能够促进患者个体健康和公共卫生系统的优化，同时也能够为环境与健康政策制定提供科学依据。  

Objectives of Study：

This study aims to further explore the intervention effect of air warning application on patients with COPD based on the platform for environmental health risk assessment of chronic respiratory diseases established in the 2023 key discipline construction of public health in Minhang District - "Environmental Risk Assessment and Intervention Strategies and Application Research for Chronic Respiratory Diseases". Through a prospective randomized controlled study conducted in Jiangcun Subdistrict, Zhuanchiao Town, and Maqiao Town in Minhang District, cross-sectional data were obtained through community questionnaires and pulmonary function tests. According to the inclusion criteria, patients were randomly assigned to three groups (control group, education and publicity intervention, air quality warning intervention), and a 1-year intervention was carried out on them to evaluate the impact of different management models on COPD patients. This study is closely related to the theme of "Healthy Earth, Healthy Humans" in the era. The expected research results are expected to not only promote individual patient health and the optimization of the public health system, but also provide scientific basis for the formulation of environmental and health policies.

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.年龄在40-80岁，具有沪籍登记，为闵行区江川路街道、颛桥镇及马桥镇的常住人口。
2.符合《慢性阻塞性肺疾病诊疗指南（2021年修订版）》中COPD稳定期的诊断标准。
3.患者愿意参与研究，并签署知情同意书。

Inclusion criteria

1.Aged 40-80 years old, with Shanghai registration, permanent residents of Jiangchuan Road, Zhuanqiao Town and Maqiao Town in Minhang District.
2.It meets the diagnostic criteria for stable COPD in the Diagnosis and Treatment Guidelines for Chronic Obstructive Pulmonary Disease (Revised 2021).
3.Patients are willing to participate in the study and sign informed consent.

排除标准：

1.目前处于急性加重期或在稳定期间具有急性加重高风险的患者；
2.无法配合肺功能检查或有肺功能检查禁忌的患者；
3.有严重精神疾病或认知功能障碍的患者；
4.患有严重心脑血管疾病的患者；
5.妊娠中、参与其他临床试验干预或活动受限制等特殊情况的患者；
6.已经接受特定治疗或具有其他主要健康问题的患者；
7.患者在过去一定时间内接受过其他可能影响研究结果的治疗或干预。

Exclusion criteria：

1.Patients who are currently in an acute exacerbation or are at high risk of acute exacerbation during a stable period;
2.Patients who are unable to cooperate with lung function tests or have contraindications in lung function tests;
3.Patients with severe mental illness or cognitive impairment;
4.Patients with severe cardiovascular and cerebrovascular diseases;
5.Patients who are pregnant, participate in other clinical trial interventions, or have special circumstances such as limited activities;
6.Patients who are already receiving specific treatment or have other major health problems;
7.Patients had received other treatments or interventions in the past that could have affected the study results.

研究实施时间：

Study execute time：

从 From 2024-05-15 00:00:00至 To 2026-05-15 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-12-28 00:00:00 至 To 2025-01-31 00:00:00  

干预措施：

Interventions：

组别：

干预组2（空气质量预警预报微信小程序干预）

样本量：

67

Group：

Intervention group 2 (air quality warning and forecasting wechat mini program intervention)

Sample size：

干预措施：

空气质量预警预报微信小程序干预

干预措施代码：

Intervention：

Air quality warning and forecasting wechat mini program intervention

Intervention code：

组别：

干预组1（宣传教育干预）

样本量：

67

Group：

Intervention Group 1 (Publicity and Education Intervention)

Sample size：

干预措施：

宣传教育干预

干预措施代码：

Intervention：

Publicity and Education Intervention

Intervention code：

组别：

对照组

样本量：

67

Group：

Control group

Sample size：

干预措施：

接受常规的COPD管理，包括医疗服务、药物治疗和基础健康教育。

干预措施代码：

Intervention：

Receive routine COPD management, including medical services, medication, and basic health education.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海市 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海市第五人民医院 

单位级别：

三级乙等 

Institution
hospital：

Shanghai Fifth Peoople's Hospital

Level of the institution：

Tertiary B

测量指标：

Outcomes：

指标中文名：

干预期间急性加重次数

指标类型：

主要指标

Outcome：

The number of acute exacerbations during the intervention period

Type：

Primary indicator

测量时间点：

干预期间每季度一次

测量方法：

医院的就诊记录和患者自我报告

Measure time point of outcome：

Once every quarter during the intervention period

Measure method：

Hospital attendance records and patient self-reports

指标中文名：

C反应蛋白

指标类型：

次要指标

Outcome：

C-reactive Protein

Type：

Secondary indicator

测量时间点：

干预前后各一次

测量方法：

采集研究对象清晨空腹肘静脉血3ml，经离心处理后，采用多重流式免疫荧光法，使用上海赛汉生物技术有限公司配套试剂盒及 RaiseCyte2L6C 细胞仪进行同步检测。

Measure time point of outcome：

Once before the intervention and once after the intervention

Measure method：

Three milliliters of fasting elbow venous blood were collected from the research subjects in the early morning. After centrifugation, the samples were simultaneously detected using the multiplex flow cytometry immunofluorescence method with the reagent kits provided by Shanghai Saihan Biotechnology Co., Ltd. and the RaiseCyte2L6C cytometer.

指标中文名：

FEV1/FVC

指标类型：

次要指标

Outcome：

Forced Expiratory Volume in One Second / Forced Vital Capacity

Type：

Secondary indicator

测量时间点：

干预前后各一次

测量方法：

肺功能检测由专业技术人员使用校准过的 COSMED Pony FX 型肺功能仪进行。

Measure time point of outcome：

Once before the intervention and once after the intervention

Measure method：

Pulmonary function was assessed by professional technicians using a calibrated COSMED Pony FX spirometer

指标中文名：

FEV1

指标类型：

次要指标

Outcome：

Forced Expiratory Volume in One Second

Type：

Secondary indicator

测量时间点：

干预前后各一次

测量方法：

肺功能检测由专业技术人员使用校准过的 COSMED Pony FX 型肺功能仪进行。

Measure time point of outcome：

Once before the intervention and once after the intervention

Measure method：

Pulmonary function was assessed by professional technicians using a calibrated COSMED Pony FX spirometer

指标中文名：

PEF

指标类型：

次要指标

Outcome：

Peak Expiratory Flow

Type：

Secondary indicator

测量时间点：

干预前后各一次

测量方法：

肺功能检测由专业技术人员使用校准过的 COSMED Pony FX 型肺功能仪进行。

Measure time point of outcome：

Once before the intervention and once after the intervention

Measure method：

Pulmonary function was assessed by professional technicians using a calibrated COSMED Pony FX spirometer

指标中文名：

mMRC评分

指标类型：

次要指标

Outcome：

modified Medical Research Council Dyspnea Scale Score

Type：

Secondary indicator

测量时间点：

干预前后各一次

测量方法：

标准化问卷调查

Measure time point of outcome：

Once before the intervention and once after the intervention

Measure method：

Standardized questionnaire survey

指标中文名：

TLR4

指标类型：

次要指标

Outcome：

Toll-like Receptor 4

Type：

Secondary indicator

测量时间点：

干预前后各一次

测量方法：

采集研究对象清晨空腹肘静脉血3ml，经离心处理后，采用多重流式免疫荧光法，使用上海赛汉生物技术有限公司配套试剂盒及 RaiseCyte2L6C 细胞仪进行同步检测。

Measure time point of outcome：

Once before the intervention and once after the intervention

Measure method：

Three milliliters of fasting elbow venous blood were collected from the research subjects in the early morning. After centrifugation, the samples were simultaneously detected using the multiplex flow cytometry immunofluorescence method with the reagent kits provided by Shanghai Saihan Biotechnology Co., Ltd. and the RaiseCyte2L6C cytometer.

指标中文名：

肿瘤坏死因子-α

指标类型：

次要指标

Outcome：

Tumor Necrosis Factor-α

Type：

Secondary indicator

测量时间点：

干预前后各一次

测量方法：

采集研究对象清晨空腹肘静脉血3ml，经离心处理后，采用多重流式免疫荧光法，使用上海赛汉生物技术有限公司配套试剂盒及 RaiseCyte2L6C 细胞仪进行同步检测。

Measure time point of outcome：

Once before the intervention and once after the intervention

Measure method：

Three milliliters of fasting elbow venous blood were collected from the research subjects in the early morning. After centrifugation, the samples were simultaneously detected using the multiplex flow cytometry immunofluorescence method with the reagent kits provided by Shanghai Saihan Biotechnology Co., Ltd. and the RaiseCyte2L6C cytometer.

指标中文名：

白介素-33

指标类型：

次要指标

Outcome：

Interleukin-33

Type：

Secondary indicator

测量时间点：

干预前后各一次

测量方法：

采集研究对象清晨空腹肘静脉血3ml，经离心处理后，采用多重流式免疫荧光法，使用上海赛汉生物技术有限公司配套试剂盒及 RaiseCyte2L6C 细胞仪进行同步检测。

Measure time point of outcome：

Once before the intervention and once after the intervention

Measure method：

Three milliliters of fasting elbow venous blood were collected from the research subjects in the early morning. After centrifugation, the samples were simultaneously detected using the multiplex flow cytometry immunofluorescence method with the reagent kits provided by Shanghai Saihan Biotechnology Co., Ltd. and the RaiseCyte2L6C cytometer.

指标中文名：

SGRQ评分

指标类型：

次要指标

Outcome：

St. George's Respiratory Questionnaire Score

Type：

Secondary indicator

测量时间点：

干预前后各一次

测量方法：

标准化问卷调查

Measure time point of outcome：

Once before the intervention and once after the intervention

Measure method：

Standardized questionnaire survey

指标中文名：

CAT评分

指标类型：

次要指标

Outcome：

COPD Assessment Test Score

Type：

Secondary indicator

测量时间点：

干预前后各一次

测量方法：

标准化问卷调查

Measure time point of outcome：

Once before the intervention and once after the intervention

Measure method：

Standardized questionnaire survey

指标中文名：

年均住院次数/费用

指标类型：

次要指标

Outcome：

Annual average number of hospitalizations / costs

Type：

Secondary indicator

测量时间点：

干预前后各一次

测量方法：

医院的就诊记录和患者自我报告

Measure time point of outcome：

Once before the intervention and once after the intervention

Measure method：

Hospital attendance records and patient self-reports

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 40 岁 years
最大 Max age 80 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）：

b)在干预前对研究对象进行基线评估，包括年龄、性别、疾病严重程度（肺功能分级）及吸烟史等，将疾病严重程度作为预测因子，根据预测因子的不同水平进行分层，在每个层次内使用简单随机化方法将患者分成三组，确保每个层次内各组的样本大小相似。

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

b) Baseline assessment was performed on the subjects before intervention, including age, sex, disease severity (lung function grade) and smoking history, etc. Disease severity was used as a predictor, stratified according to different levels of predictors, and patients were divided into three groups using simple randomization within each level to ensure that the sample sizes of each group were similar within each level.

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 study

是否共享原始数据：

IPD sharing

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）：

国家生物信息中心 China National Center for Bioinformation（https://ngdc.cncb.ac.cn/gsub/）；共享计划时间：最后 1 例研究参与者出组后 3 个月内（预计 2025年 10 月 31 日前）完成数据上传及共享开放。

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

National Bioinformatics Center China National Center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/); Sharing plan duration: Data upload and sharing will be completed within 3 months after the last study participant is discharged (estimated by October 31, 2025).

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：

1）对象信息收集：包括患者基本信息（年龄、性别、职业、教育背景等）和健康相关行为（吸烟史、运动习惯等）。 专用量表评分：SGRQ量表、CAT评分及mMRC评分以更全面评估COPD患者症状和生活质量。 2）调研员培训： A.强化培训：确保调查员熟悉问卷内容、采访技巧、数据录入和患者隐私保护。 B.角色模拟：进行问卷调查的模拟训练，提高调查员应对各种实际情况的能力。 3）问卷调查： 问卷实施：按照标准化程序对受试者进行面对面问卷调查。 跟踪与反馈：建立跟踪机制，确保高质量数据的收集和及时反馈。 4）肺功能检查： 由具备肺功能资质的专业技术员进行肺功能检测。检测仪器为意大利科时迈肺功能仪，产品型号Pony FX。 检查准备：对仪器进行日常校准，并记录检查环境的温度、气压、湿度。 测试标准：执行国际认可的肺功能检查指南，并对测试结果进行三次重复，以确保可靠性。 5）酶联免疫吸附试验 采集受试者清晨空腹肘静脉血3ml,离心半径10cm、2000r/min离心10min，收集血清，于-70℃下保持待测。运用酶联免疫吸附试验测定血清TLR4、IL-33、CRP和TNF-α水平，严格依据试剂盒说明书测定。干预前后各一次。 6.质量控制： 1）预测试： 实施小规模的试点调查，以评估和优化问卷设计、调查流程和数据收集方法。 2）问卷标准化保证： 制定详细的问卷填写指南，确保问卷内容的标准化和受试者理解的统一。 3）调查人员培训： 定期进行调查人员的继续教育和技能提升，确保调查质量。 4）数据清洗： 实施数据质量控制流程，包括逻辑检查、范围检查和一致性检查，以及数据的净化和验证。

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

1) Object information collection: including patients' basic information (age, gender, occupation, educational background, etc.) and health-related behaviors (smoking history, exercise habits, etc.). Special scale score: SGRQ scale, CAT score and mMRC score to evaluate the symptoms and quality of life of COPD patients more comprehensively. 2) Researcher training: A. Intensive training: ensure that investigators are familiar with questionnaire content, interview techniques, data entry and patient privacy protection. B. Role simulation: Conduct simulation training of questionnaire survey to improve the ability of investigators to cope with various practical situations. 3) Questionnaire survey: Questionnaire implementation: Face-to-face questionnaire survey was conducted according to standardized procedures. Tracking and feedback: Establish a tracking mechanism to ensure high-quality data collection and timely feedback. 4) Lung function test: The lung function test is performed by a qualified professional technician. The testing instrument is the Italian Keshi Mai lung function instrument, product model Pony FX. Preparation for inspection: Perform daily calibration of the instrument, and record the temperature, pressure and humidity of the inspection environment. Test standards: Perform internationally recognized lung function test guidelines and repeat the test results three times to ensure reliability. 5) Enzyme-linked immunosorbent assay 3ml of fasting elbow venous blood was collected from the subjects in the morning, centrifuged at a radius of 10cm and 2000r/min for 10min. Serum was collected and kept at -70℃ for testing. Serum levels of TLR4, IL-33, CRP and TNF-α were determined by enzyme-linked immunosorbent assay (ELISA) in strict accordance with kit instructions. Once before and after the intervention. 6. Quality control: 1) Pre-test: Conduct a small pilot survey to evaluate and optimize questionnaire design, survey process, and data collection methods. 2) Questionnaire standardization guarantee: Formulate detailed questionnaire filling guidelines to ensure the standardization of questionnaire content and the unity of subjects' understanding. 3) Investigator training: Continuing education and skill upgrading of investigators are conducted regularly to ensure the quality of investigations. 4) Data cleaning: Implement data quality control processes, including logic checks, scope checks and conformance checks, as well as data purification and validation.

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Data and Safety Monitoring Committee：

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  2026-01-11 18:54:31
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