About this trial
To develop and externally validate a machine learning model for predicting the 1-year risk of relapse in patients with stable ABPA, and to further evaluate its value in risk stratification and clinical decision-making.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female and Male patients aged 18-80 years
diagnosis of Allergic Bronchopulmonary Aspergillosis ABPA accroding to the 2024 ISHAM Working Group Diagnostic Criteria
Disqualifiers
Patients with malignant tumors or severe organ dysfunction (e.g., cardiac, cerebral, renal, etc.)
Patients with severe comorbidities, including active pulmonary tuberculosis, lung cancer, chronic heart failure (NYHA class Ⅳ), chronic kidney disease (CKD stage 5), decompensated cirrhosis, etc.
Patients with immunosuppressive status, such as HIV infection, long-term use of oral corticosteroids or immunosuppressive agents.
Pregnant or lactating women.
Trial population
1)Female and Male patients aged 18-75 years inclusively at the time of Visit 1 with a physician diagnosis of Allergic Bronchopulmonary Aspergillosis has met the ISHAM Working Group Diagnostic Criteria for ABPA 2)These patients who were clearly diagnosed with ABPA are currently in stable phase
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Recurrent disease occurs in patients during the remission period.
Observe whether disease recurrence occurs in ABPA patients who have reached stable phase after treatment. Stable Phase: 1. Symptomatic improvement by at least 50% (on a Likert or visual analog scale) after eight weeks; and, 2. Major radiological improvement (\>50% reduction in radiologic opacities) or decline in serum total IgE by at least 20% after eight weeks of treatment. Exacerbation/Recurrence: In a patient with diagnosed ABPA 1. Sustained (\>14 days) clinical worsening, or 2. Radiological worsening, and 3. Increase in serum total IgE by ≥50% from the last recorded IgE value during clinical stability, along with 4. Exclusion of other causes of worsening.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.