Predicting Exacerbation Risk in Severe COPD Patients

A Risk-predictive Model for Frequent Acute Exacerbation Phenotype in Patients With Severe Chronic Obstructive Pulmonary Disease

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
• Enrollment: 365 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Beijing Chao Yang Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06198309 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 40 years old with stable severe COPD who meet the GOLD 2022 diagnostic criteria.

Not a fit: Patients with asthma, active pulmonary tuberculosis, or other serious comorbidities may not benefit from this study.

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 performed: While similar studies have explored COPD exacerbation risk, this specific approach using gut microbiota and advanced machine learning is relatively novel.

Eligibility 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 this trial is running

Beijing, Beijing Municipality

• Beijing Chaoyang Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Li An

Conditions Chronic Obstructive Pulmonary Disease Severe