Fungal Status and Prognosis in ABPA

NCT07690345 | Recruiting

• 1 other identifier: ABPA-005
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

ABPA; Allergic Bronchopulmonary Aspergillosis; Colonization; Allergic Bronchopulmonary Aspergillosis (ABPA)

Keywords

ABPA; Aspergillus; bronchiectasis; fungal colonization; BALF; galactomannan; allergic bronchopulmonary mycosis

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  12 months after enrollment

Secondary Outcomes (6)

• Immunological response indicators

  12 months after enrollment

• Pulmonary function parameters

  12 months after enrollment

• Radiological changes

  12 months after enrollment

• Treatment response

  12 months after enrollment

• Clinical outcomes and healthcare utilization

  12 months after enrollment

Study Arms (2)

Fungal-Positive ABPA

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.

Fungal-Negative ABPA

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Patients hospitalized during the study period in participating centers with sputum or bronchoalveolar lavage fluid (BALF) collection performed.
• 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).
• Availability of complete and traceable clinical data, including medical history, imaging, laboratory tests, treatment records, and follow-up information, with no critical missing data.
• Willingness to participate in follow-up and signed informed consent (for prospective participants), with good compliance for follow-up.
• No systemic antifungal therapy or other interventions that may significantly affect mycological test results within 1 month prior to enrollment.

You may not qualify if:

• Coexisting pulmonary fungal infections (e.g., invasive pulmonary aspergillosis) or other confirmed non-fungal pulmonary infections.
• Presence of other structural lung diseases, such as pulmonary tuberculosis, lung cancer, or lung abscess.
• Severe immunodeficiency or other significant allergic pulmonary diseases that may confound the diagnosis of ABPA.
• 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.
• Systemic antifungal treatment within 1 month prior to enrollment or participation in another interventional clinical trial.
• Contraindications to bronchoscopy/BAL procedures or known severe allergy to relevant reagents used in testing.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China

Jinan, Shandong, 250014, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sputum samples and bronchoalveolar lavage fluid (BALF) will be collected from eligible patients. Blood samples may also be obtained for serum immunological analysis. BALF and sputum specimens will be used for fungal culture, galactomannan (GM) testing, and targeted next-generation sequencing (tNGS) to detect Aspergillus species and other clinically relevant fungal pathogens. Samples may be stored for future DNA-based analyses related to fungal characterization and host-pathogen interactions.

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary; Bronchiectasis; Invasive Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Invasive Fungal Infections

Central Study Contacts

Qian Qi, Dr.

CONTACT

+86 13706380314; qiqianqlh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)