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NCT Number: NCT07690345

Fungal Status and Prognosis in ABPA

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Location status: Recruiting

Location contact

Qian Qi, Dr.

CONTACT

[email protected]

+86 13706380314

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Annual acute exacerbation rate

    Time frame: 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).

  2. Time to first acute exacerbation

    Time frame: 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 outcomes

  1. Immunological response indicators

    Time frame: 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.

  2. Pulmonary function parameters

    Time frame: 12 months after enrollment

    Changes in pulmonary function including FEV1 (% predicted)

  3. Radiological changes

    Time frame: 12 months after enrollment

    Changes in chest CT features including extent of bronchiectasis, mucus plugging, and high-attenuation mucus (HAM) scores.

  4. Treatment response

    Time frame: 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.

  5. Clinical outcomes and healthcare utilization

    Time frame: 12 months after enrollment

    Number of acute exacerbations, hospitalization frequency, hospital length of stay, and other adverse clinical outcomes during follow-up.

  6. Changes in FEV1/FVC ratio

    Time frame: 12 months after enrollment

    Changes in FEV1/FVC ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Qi, Dr.

CONTACT

[email protected]

+86 13706380314

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

Clinical Characteristics and Prognostic Outcomes of Allergic Bronchopulmonary Aspergillosis Patients Stratified by Fungal Microbiological Status in Sputum or Bronchoalveolar Lavage Fluid: A Multicenter Bidirectional Cohort Study

Acronym: ABPAFUNGAL

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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