An observational study in ABPA, Allergic Bronchopulmonary Aspergillosis and Allergic Bronchopulmonary Aspergillosis (ABPA), sponsored by Qianfoshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Qianfoshan Hospital · Observational
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.
42 studies on the registry are indexed under Aspergillosis, Allergic Bronchopulmonary; 13 are open to participants now.
This study's planned enrollment of 114 is above the median of 73 across 14 observational studies indexed under Aspergillosis, Allergic Bronchopulmonary.
Browse Aspergillosis, Allergic Bronchopulmonary studies →Qianfoshan Hospital is the lead sponsor of 144 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will include adult patients (≥18 years old) diagnosed with allergic bronchopulmonary aspergillosis (ABPA) according to the 2024 ISHAM diagnostic criteria. The study population consists of retrospectively identified cases from participating hospitals' electronic medical records and prospectively enrolled patients during the study period. Eligible patients must have undergone sputum or bronchoalveolar lavage fluid (BALF) sampling with at least one mycological test (culture, GM assay, mNGS, or tNGS) and have complete clinical, imaging, laboratory, treatment, and follow-up data. Participants will be stratified into BALF/sputum mycological positive and negative groups. Patients with coexisting pulmonary fungal infections, missing key data, or inability to complete follow-up will be excluded.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (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. to bronchoscopy/BAL procedures or known severe allergy to relevant reagents used in testing.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with allergic bronchopulmonary aspergillosis according to ISHAM 2024 criteria who demonstrate at least one positive result in sputum or bronchoalveolar lavage fluid (BALF) fungal testing, including fungal culture, galactomannan (GM) assay, or targeted next-generation sequencing (tNGS) detecting Aspergillus species.
Patients diagnosed with allergic bronchopulmonary aspergillosis according to ISHAM 2024 criteria with negative results in all fungal tests performed on sputum or bronchoalveolar lavage fluid (BALF), including fungal culture, galactomannan (GM) assay, and targeted next-generation sequencing (tNGS).
Annual acute exacerbation rate
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 frame: 12 months after enrollment
Time to first acute exacerbation
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.
Time frame: 12 months after enrollment
Immunological response indicators
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.
Time frame: 12 months after enrollment
Pulmonary function parameters
Changes in pulmonary function including FEV1 (% predicted)
Time frame: 12 months after enrollment
Radiological changes
Changes in chest CT features including extent of bronchiectasis, mucus plugging, and high-attenuation mucus (HAM) scores.
Time frame: 12 months after enrollment
Treatment response
Treatment response including corticosteroid dosage and duration, antifungal therapy regimen and duration, symptom improvement, and changes in IgE levels and radiological lesion absorption.
Time frame: 12 months after enrollment
Clinical outcomes and healthcare utilization
Number of acute exacerbations, hospitalization frequency, hospital length of stay, and other adverse clinical outcomes during follow-up.
Time frame: 12 months after enrollment
Changes in FEV1/FVC ratio
Changes in FEV1/FVC ratio
Time frame: 12 months after enrollment
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Dec 2028, 41 months after the start.
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Aspergillosis, Allergic Bronchopulmonary →