Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT06918353
The Severity Assessment Model for AECOPD With Combination of Disease and Syndrome
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The establishment of the AECOPD severity assessment model can quickly and accurately evaluate the condition, which is of great significance for standardizing diagnosis and treatment, improving efficacy, and improving prognosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- Diagnosis and Severity Grading of AECOPD Disease
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Who may be able to join
- Meets AECOPD diagnostic criteria.
- Voluntarily participate in the research and sign the consent form
Who cannot join
- Individuals with severe mental disorders and cognitive impairments who are unable to communicate normally
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Hailong H Zhang, doctor, +86-0371-66248624, zhanghailong6@126.com
About this study
Official title: Construction and Evaluation of the Severity Assessment Model for AECOPD With Combination of Disease and Syndrome Based on Machine Learning
The establishment of the AECOPD severity assessment model can quickly and accurately evaluate the condition, which is of great significance for standardizing diagnosis and treatment, improving efficacy, and improving prognosis. At the same time, it can provide ideas and methods for the research of disease assessment models in related fields.
Read the detailed description
Accurate assessment of the condition is the prerequisite and basis for standardized clinical treatment. Traditional Chinese medicine has shown good efficacy and advantages in treating AECOPD, but currently there is no ideal standard for judging the severity, nor is there an accurate, practical, and TCM specific disease assessment tool. Therefore, this project integrates multidimensional variables of traditional Chinese and Western medicine, and intends to conduct research on the construction of a disease syndrome combined AECOPD disease assessment model through literature review, expert consultation, clinical investigation, and machine learning algorithms, and establish preliminary grading standards for the severity of AECOPD disease. Ultimately, it provides ideas and methods for the rapid and accurate assessment of AECOPD, standardized diagnosis and treatment, improved efficacy, improved prognosis, and research on disease assessment models in related fields.
- Being tested
- Diagnosis and Severity Grading of AECOPD Disease
- Keywords
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Severity Assessment Model, Combination of Disease and Syndrome, Classification and Regression Trees, Artificial Neural Network
- Medical subject headings
- Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis and Severity Grading of AECOPD DiseaseDiagnostic test
Diagnosis and severity grading of AECOPD disease, as well as assessment of traditional Chinese medicine syndromes
| Study group | Role | What they receive |
|---|---|---|
| AECOPD Patients | Not described Receives: Diagnostic Test: Diagnosis and Severity Grading of AECOPD Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Investigation Questionnaire on Influencing Factors of the Severity of AECOPD
The influencing factors of the severity of AECOPD were evaluated through clinical investigation questionnaires.
Questionnaire Title: Clinical Investigation Questionnaire on Influencing Factors of AECOPD Severity.
The questionnaire adopts the scoring method, which is divided into "very unimportant", "not important", "average", "important" and "very important", and the corresponding values are assigned as 1, 2, 3, 4 and 5 respectively.The higher the score is, the more significant the result is.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Henan Provincial People's Hospital, Third Affiliated Hospital of Henan University of Traditional Chinese Medicine, Jiangsu province hospital of TCM, Qingdao Traditional Chinese Medicine Hospital(Qingdao Hiser Hospital), Xiangyang Hospital of Traditional Chinese Medicine, Yanshi People's Hospital of Luoyang City, Shangcai County Traditional Chinese Medicine Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918353
- Sponsor's protocol ID
- Model for AECOPD
- Status last verified
- Apr 2025
- First submitted
- 27 Jan 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang HL, Liu JM, Li Y, Wang LY, Jia PL, Yao ZX. Development and validation of a disease-syndrome integrated assessment model for AECOPD severity: protocol for a nationwide multicentre cross-sectional study. BMJ Open Respir Res. 2026 Jul 9;13(1):e003781. doi: 10.1136/bmjresp-2025-003781.
PubMed 42425737
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Evaluation of the Severity Assessment Model for AECOPD With Combination of Disease and Syndrome Based on Machine Learning
- ClinicalTrials.gov ID
- NCT06918353
- Acronym / sponsor ID
- Model for AECOPD
- Keywords
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Severity Assessment Model, Combination of Disease and Syndrome, Classification and Regression Trees, Artificial Neural Network
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Henan Provincial People's Hospital, Third Affiliated Hospital of Henan University of Traditional Chinese Medicine, Jiangsu province hospital of TCM, Qingdao Traditional Chinese Medicine Hospital(Qingdao Hiser Hospital), Xiangyang Hospital of Traditional Chinese Medicine, Yanshi People's Hospital of Luoyang City, Shangcai County Traditional Chinese Medicine Hospital
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The establishment of the AECOPD severity assessment model can quickly and accurately evaluate the condition, which is of great significance for standardizing diagnosis and treatment, improving efficacy, and improving prognosis. At the same time, it can provide ideas and methods for the research of disease assessment models in related fields.
Detailed description
Accurate assessment of the condition is the prerequisite and basis for standardized clinical treatment. Traditional Chinese medicine has shown good efficacy and advantages in treating AECOPD, but currently there is no ideal standard for judging the severity, nor is there an accurate, practical, and TCM specific disease assessment tool. Therefore, this project integrates multidimensional variables of traditional Chinese and Western medicine, and intends to conduct research on the construction of a disease syndrome combined AECOPD disease assessment model through literature review, expert consultation, clinical investigation, and machine learning algorithms, and establish preliminary grading standards for the severity of AECOPD disease. Ultimately, it provides ideas and methods for the rapid and accurate assessment of AECOPD, standardized diagnosis and treatment, improved efficacy, improved prognosis, and research on disease assessment models in related fields.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AECOPD Patients | – | Diagnostic Test: Diagnosis and Severity Grading of AECOPD Disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Key inclusion criteria (2 listed)
- Meets AECOPD diagnostic criteria.
- Voluntarily participate in the research and sign the consent form
Key exclusion criteria (1 listed)
- Individuals with severe mental disorders and cognitive impairments who are unable to communicate normally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis and Severity Grading of AECOPD DiseaseDiagnosis and severity grading of AECOPD disease, as well as assessment of traditional Chinese medicine syndromes | Diagnostic test | AECOPD Patients |
Primary outcome
Clinical Investigation Questionnaire on Influencing Factors of the Severity of AECOPD
Time frame: 24 hours
The influencing factors of the severity of AECOPD were evaluated through clinical investigation questionnaires. Questionnaire Title: Clinical Investigation Questionnaire on Influencing Factors of AECOPD Severity. The questionnaire adopts the scoring method, which is divided into "very unimportant", "not important", "average", "important" and "very important", and the corresponding values are assigned as 1, 2, 3, 4 and 5 respectively.The higher the score is, the more significant the result is.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 42425737Zhang HL, Liu JM, Li Y, Wang LY, Jia PL, Yao ZX. Development and validation of a disease-syndrome integrated assessment model for AECOPD severity: protocol for a nationwide multicentre cross-sectional study. BMJ Open Respir Res. 2026 Jul 9;13(1):e003781. doi: 10.1136/bmjresp-2025-003781.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hailong H Zhang, doctor (+86-0371-66248624, zhanghailong6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Investigation Questionnaire on Influencing Factors of the Severity of AECOPD (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06918353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.