Fungal fingerprints in lungs may predict ABPA Flare-Ups
NCT ID NCT07690345
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This study looks at people with allergic bronchopulmonary aspergillosis (ABPA), a lung condition caused by an allergic reaction to a common fungus. Researchers want to see if having fungus detectable in sputum or lung fluid samples is linked to more frequent flare-ups or worse outcomes. Participants will be followed for 12 months to track exacerbations and changes in immune markers and lung function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If fungal status predicts outcomes, doctors could tailor treatments more precisely for ABPA patients.
- What could go wrong
- This is an observational study, not a treatment trial. It may not prove cause and effect, and results might not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
RECRUITINGJinan, Shandong, 250014, China
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Other studies related to the condition(s) this trial covers.
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- AI model aims to predict ABPA relapse risk
- New drug could tame severe asthma and fungal allergy