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Recruiting Observational

A Study of the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With ABPA

NCT07362667 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-01-10
Last updated
2026-01-23

Condition(s) studied

ABPAAllergic Bronchopulmonary AspergillosisAllergic Bronchopulmonary Aspergillosis (ABPA)Airway ClearanceMucus PlugAmphotericin BBronchoscope

Investigational drug(s) / intervention(s)

The patients were treated with bronchoscopic airway clearance and amphotericin B spraying

The patients were treated with bronchoscopic airway clearance and amphotericin B spraying: In addition to standard medical therapy (oral glucocorticoids with or without oral antifungal agents), bronchoscopic airway clearance and bronchoscopic spraying of amphotericin B (depending on the effectiveness of bronchoscopic mucus plug removal, At least one time of bronchoscopic airway clearance and amphotericin B spraying). The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc.

Study summary

To evaluate the efficacy and safety of bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Radiographic response rate after 4 months of treatment — 4 months
    Radiographic remission: defined as the removal of mucus plugs in the airway on radiographic examination
  • Immunological remission rate after 4 months of treatment — 4 months
    Immunological remission: defined as at least a 50% decrease in total serum IgE from baseline
  • The remission rate of clinical symptoms after 4 months of treatment — 4 months
    Clinical symptom relief: The semi-quantitative rating of clinical symptoms was evaluated using Likert scores with at least 50% improvement in symptoms

Trial sites (1)

FacilityCityRegionStatus
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 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07362667 on ClinicalTrials.gov ↗ ← All trials in China