ABPA, Allergic Bronchopulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis (ABPA), Colonization
Conditions
Keywords
ABPA, Aspergillus, bronchiectasis, fungal colonization, BALF, galactomannan, allergic bronchopulmonary mycosis
Brief summary
This multicenter bidirectional cohort study aims to investigate the clinical characteristics and prognostic outcomes of patients with allergic bronchopulmonary aspergillosis (ABPA) stratified by fungal microbiological status in sputum or bronchoalveolar lavage fluid (BALF). Patients diagnosed with ABPA according to the ISHAM 2024 criteria will be classified into fungal-positive and fungal-negative groups based on results from fungal culture, galactomannan (GM) testing, and metagenomic next-generation sequencing (mNGS) of sputum or BALF samples. The study will compare baseline clinical features, laboratory findings, radiological characteristics, treatment response, and long-term outcomes, including acute exacerbation rate and time to first exacerbation, between the two groups. All participants will be followed for up to 12 months with serial clinical and laboratory assessments.
Interventions
None listed
Sponsors
Qianfoshan Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1.Adult patients (≥18 years old) diagnosed with allergic bronchopulmonary aspergillosis (ABPA) according to the 2024 International Society for Human and Animal Mycology (ISHAM) diagnostic criteria. 2.Patients hospitalized during the study period in participating centers with sputum or bronchoalveolar lavage fluid (BALF) collection performed. 3.At least one mycological test performed on sputum or BALF, including fungal culture, galactomannan (GM) assay, metagenomic next-generation sequencing (mNGS), or targeted next-generation sequencing (tNGS), with clearly interpretable results (positive or negative). 4.Availability of complete and traceable clinical data, including medical history, imaging, laboratory tests, treatment records, and follow-up information, with no critical missing data. 5.Willingness to participate in follow-up and signed informed consent (for prospective participants), with good compliance for follow-up. 6.No systemic antifungal therapy or other interventions that may significantly affect mycological test results within 1 month prior to enrollment.
Exclusion criteria
* 1.Coexisting pulmonary fungal infections (e.g., invasive pulmonary aspergillosis) or other confirmed non-fungal pulmonary infections. 2.Presence of other structural lung diseases, such as pulmonary tuberculosis, lung cancer, or lung abscess. 3.Severe immunodeficiency or other significant allergic pulmonary diseases that may confound the diagnosis of ABPA. 4.Absence of sputum or BALF samples, or lack of valid mycological test results. 5.Incomplete key clinical data (e.g., total IgE, Aspergillus-specific IgE/IgG, imaging, or pulmonary function data) or inability to complete at least 3 months of follow-up. 6.Systemic antifungal treatment within 1 month prior to enrollment or participation in another interventional clinical trial. 7.Contraindications to bronchoscopy/BAL procedures or known severe allergy to relevant reagents used in testing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual acute exacerbation rate | 12 months after enrollment | The annual acute exacerbation rate will be defined as the number of disease exacerbations requiring systemic corticosteroids, antibiotics, or hospitalization within 12 months of follow-up in patients with allergic bronchopulmonary aspergillosis (ABPA), stratified by fungal microbiological status in sputum or bronchoalveolar lavage fluid (BALF). |
| Time to first acute exacerbation | 12 months after enrollment | Time from enrollment to the first occurrence of acute exacerbation of ABPA, defined by clinical worsening requiring systemic corticosteroid escalation, hospitalization, or documented physician diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunological response indicators | 12 months after enrollment | Changes in immunological biomarkers including total serum IgE, Aspergillus-specific IgE and IgG levels, peripheral blood eosinophil counts, and fractional exhaled nitric oxide (FeNO) will be evaluated during follow-up. |
| Pulmonary function parameters | 12 months after enrollment | Changes in pulmonary function including FEV1 (% predicted) |
| Radiological changes | 12 months after enrollment | Changes in chest CT features including extent of bronchiectasis, mucus plugging, and high-attenuation mucus (HAM) scores. |
| Treatment response | 12 months after enrollment | Treatment response including corticosteroid dosage and duration, antifungal therapy regimen and duration, symptom improvement, and changes in IgE levels and radiological lesion absorption. |
| Clinical outcomes and healthcare utilization | 12 months after enrollment | Number of acute exacerbations, hospitalization frequency, hospital length of stay, and other adverse clinical outcomes during follow-up. |
| Changes in FEV1/FVC ratio | 12 months after enrollment | Changes in FEV1/FVC ratio |
Countries
China
Contacts
CONTACTQian Qi, Dr.
Outcome results
None listed