Risk Prediction Model for Exacerbating Phenotype in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT06198309

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

365 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2027-12-01

Brief Summary

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This study is planned to be conducted based on the cohort of patients with severe chronic obstructive pulmonary disease in our hospital. Based on gut microbiota, random forest was used to search for potential diagnostic biomarkers in patients with frequent acute exacerbation and controls with non frequent acute exacerbation; Construct a frequent acute exacerbation risk prediction model using random forest, support vector machine, and BP neural network models. The development of this study will provide valuable references for the clinical classification and prognosis evaluation of chronic obstructive pulmonary disease (COPD), and improve the health level of COPD patients by further searching for treatable targets.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Severe

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Frequent exacerbation of COPD

No interventions assigned to this group

Non-frequent exacerbation of COPD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients who meet the diagnostic criteria for COPD of the global initiative for chronic obstructive lung diseases (GOLD 2022) and GOLD grading Ⅲ - Ⅳ (FEV1/FVC\<70%, FEV1% predicted value ≤ 50% after Bronchiectasis)
2. Age\>40 years old
3. COPD stable for more than 4 weeks
4. Short acting Bronchiectasis was not used within 24 hours before this experiment, long acting Bronchiectasis was not used within 48 hours, and glucocorticoids were not used throughout the body in the past month
5. Patient informed and signed consent form

Exclusion Criteria

1. Asthma, active pulmonary tuberculosis, interstitial pneumonia and severe Bronchiectasis
2. Complicated with serious diseases (acute infection, diabetes, stroke, heart disease, liver and kidney dysfunction, cancer or autoimmune disease)
3. History of chronic diarrhea or constipation
4. History of Gastrointestinal Surgery
5. Using probiotics or antibiotics within the past 4 weeks
6. No history of using oral hormones or traditional Chinese medicine in the past three months
7. Pregnancy or lactation
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Li An

OTHER

Sponsor Role lead

Responsible Party

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Li An

chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Beijing Chaoyang Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li An

Role: CONTACT

CHN+13681133265

Facility Contacts

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Li An, doctorate

Role: primary

CHN+13681133265

Other Identifiers

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al123456

Identifier Type: -

Identifier Source: org_study_id

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