Predicting Exacerbation Risk in Severe COPD Patients
Official title: A Risk-predictive Model for Frequent Acute Exacerbation Phenotype in Patients With Severe Chronic Obstructive Pulmonary Disease
Run by Beijing Chao Yang Hospital · NCT06198309 · Data updated 2026-11-12
This study is trying to see if analyzing gut bacteria can help predict which patients with severe COPD are more likely to have worsening symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years to 85 Years |
| Sex | All |
| Enrollment | 365 (estimated) |
| Sponsor | Beijing Chao Yang Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | May 1, 2023 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | January 10, 2024 |
| Trial ID | NCT06198309 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 40 years old with stable severe COPD who meet the GOLD 2022 diagnostic criteria.
✕Probably not a fit
Patients with asthma, active pulmonary tuberculosis, or other serious comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to develop a risk prediction model for patients with severe chronic obstructive pulmonary disease (COPD) by analyzing gut microbiota. Using advanced machine learning techniques such as random forest, support vector machine, and BP neural network models, the study will identify potential diagnostic biomarkers that differentiate between patients with frequent and infrequent acute exacerbations. The findings are expected to enhance clinical classification and prognosis evaluation for COPD, ultimately improving patient health outcomes.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and targeted treatments for patients with severe COPD.
How similar studies have gone: While similar studies have explored COPD exacerbation risk, this specific approach using gut microbiota and advanced machine learning is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Li An
- Email: bjzy818@sina.com
- Phone: CHN+13681133265
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.