Inclusion Criteria:
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:
In patients with predisposing conditions (asthma, cystic fibrosis, chronic obstructive lung disease, bronchiectasis) or a)compatible clinico-radiological presentation
Essential components b)A. fumigatus-specific IgE ≥0.35 kUA/L c)Serum total IgE ≥500 IU/mL
Other components (any two) d)Positive IgG against A. fumigatus Peripheral blood eosinophil count ≥500 cells/µL (could be historical) Thin-section chest computed tomography consistent with ABPA (bronchiectasis, mucus plugging, and e)high-attenuation mucus) or fleeting opacities on chest radiograph consistent with ABPA
Important considerations
1. Expectoration of mucus plugs, finger-in-glove and fleeting opacities on chest radiograph, lung collapse, and others
2. A positive type 1 skin test is acceptable when Aspergillus-IgE is unavailable.
3. Serum total IgE \<500 IU/mL may be acceptable if all other criteria are fulfilled.
4. A. fumigatus-IgG can be detected using lateral flow assays or enzyme immunoassays. The cut-offs for A. fumigatus-specific IgG must be developed for specific populations (e.g., ≥27 mgA/L, ≥60 mgA/L, ≥40 mgA/L for India, Japan, and the UK, respectively). In the absence of population-specific cut-offs, we suggest using manufacturer recommendations.
5. High-attenuation mucus is pathognomonic of ABPA and confirms ABPA diagnosis even if all other criteria are not fulfilled.
Elevated IgE against rAsp f1, f2, and f4 support the diagnosis of ABPA and could be used as another component for diagnosing ABPA.
2)These patients who were clearly diagnosed with ABPA are currently in Stable Phase
Stable Phase
* Symptomatic improvement by at least 50% (on a Likert or visual analog scale) after eight weeks; and,
* Major radiological improvement (\>50% reduction in radiologic opacities) or decline in serum total IgE by at least 20% after eight weeks of treatment.
Exclusion Criteria:
① Patients with malignant tumors or severe organ dysfunction (e.g., cardiac, cerebral, renal, etc.).② 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.③ Patients with immunosuppressive status, such as HIV infection, long-term use of oral corticosteroids or immunosuppressive agents.④ Pregnant or lactating women.⑤ Patients with missing key data or incomplete medical records.
