Bronchoscopic airway clearance with amphotericin B spraying for ABPA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center observational study in Jinan, China treats adults with ABPA who have mucus plugs using bronchoscopic airway clearance followed by topical amphotericin B spraying. Eligible participants meet ISHAM diagnostic criteria and have mucus plugs or hyperattenuated mucus confirmed on high-resolution chest CT, with active disease or recent exacerbation. The protocol records clinical symptoms, total serum IgE, radiographic changes, and procedure-related adverse events over follow-up. Safety and tolerability of bronchoscopy and antifungal spraying are prospectively monitored.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Meet the diagnostic criteria of allergic bronchopulmonary aspergillosis, according to the ISHAM guidelines for the diagnosis and treatment of allergic bronchopulmonary aspergillosis (2024 revision), and the presence of mucus plugs or hyperattenuated mucus confirmed by chest high-resolution CT (HRCT).
2. Active disease: Newly diagnosed allergic bronchopulmonary aspergillosis or an acute exacerbation after discontinuation of treatment (defined as a \> 14 day history of clinical worsening or radiographic progression of allergic bronchopulmonary aspergillosis and a ≥50% increase in total serum IgE from the last recorded value during the stable phase, excluding other causes of the acute exacerbation) in patients with previously diagnosed allergic bronchopulmonary aspergillosis.
3. Age ≥ 18 years old.

Exclusion Criteria:

1. Allergic bronchopulmonary aspergillosis - serotype (i.e., meets the diagnostic criteria for allergic bronchopulmonary aspergillosis, but chest CT shows no obvious abnormality);
2. Patients with absolute or relative contraindications to electronic bronchoscopy;
3. Known history of allergy to amphotericin B or any of its excipients;
4. Patients with bronchiectasis caused by human immunodeficiency virus infection, active tuberculosis, pulmonary malignant tumor or other non-allergic bronchopulmonary aspergillosis;
5. Combined with other diseases requiring long-term systemic use of glucocorticoids or immunosuppressants (such as autoimmune diseases);
6. Patients with previous or current smoking history;
7. Pregnant or lactating women;
8. Currently participating in other interventional clinical research;
9. Any other conditions considered by the investigator to preclude participation in the study (e.g., nonadherence, predicted survival \<1 year, or severe mental illness that prevented cooperation).

Where it's running

• 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, China Recruiting

Study contacts

• Study coordinator: Qian Qi, Dr.
• Email: qiqianqlh@163.com
• Phone: +86 13706380314

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ML-based ABPA recurrence predictor in adults with ABPA

  A machine-learning model is being tested to see if it can predict the chance of an ABPA flare within a year in adults with ABPA during a stable phase.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07714863

• Fungal status and prognosis in ABPA: looking at who improves based on fungal tests

  This study checks if ABPA patients with positive or negative fungal tests in sputum or BALF have different outcomes over a year.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07690345

• Biologic treatment for adults with ABPA and severe asthma

  This project will test whether biologic medicines help adults with ABPA who have severe asthma and elevated eosinophils.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07362693

• Benralizumab treatment for adults with ABPA and severe asthma

  This will test whether benralizumab helps adults (18–75) who have severe asthma with allergic bronchopulmonary aspergillosis (ABPA).

  Recruiting at 2 sites Qianfoshan Hospital · Jinan, Shandong and 1 other locations · NCT07530770

• Can a multi-omics and AI model predict ABPA relapse within 1 year in adults?

  This study tests a machine learning model that uses multi-omics and clinical data to predict the 1-year relapse risk for adults with ABPA who are in a stable state.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07611838

• Immune status and disease control in airway inflammatory diseases

  This project will test whether specific blood immune cell patterns relate to disease control in adults with asthma, COPD, bronchiectasis, or obstructive sleep apnea by comparing them with healthy volunteers.

  Recruiting First Affiliated Hospital of Ningbo University · Ningbo, Zhejiang · NCT07493629

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.