About this trial
To evaluate the efficacy and safety of bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
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.
Age ≥ 18 years old.
Disqualifiers
Allergic bronchopulmonary aspergillosis - serotype (i.e., meets the diagnostic criteria for allergic bronchopulmonary aspergillosis, but chest CT shows no obvious abnormality);
Patients with absolute or relative contraindications to electronic bronchoscopy;
Known history of allergy to amphotericin B or any of its excipients;
Patients with bronchiectasis caused by human immunodeficiency virus infection, active tuberculosis, pulmonary malignant tumor or other non-allergic bronchopulmonary aspergillosis;
Trial population
Patients diagnosed with allergic bronchopulmonary aspergillosis included patients with newly diagnosed allergic bronchopulmonary aspergillosis and patients with acute exacerbation of allergic bronchopulmonary aspergillosis after drug withdrawal.
Trial design
Cohort
Prospective
Treatments tested in this trial
The patients were treated with bronchoscopic airway clearance and amphotericin B spraying
Procedure/SurgeryIn 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.
Treatment groups
Trial outcomes
Primary outcomes
Radiographic response rate after 4 months of treatment
Radiographic remission: defined as the removal of mucus plugs in the airway on radiographic examination
Immunological remission rate after 4 months of treatment
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
Clinical symptom relief: The semi-quantitative rating of clinical symptoms was evaluated using Likert scores with at least 50% improvement in symptoms
Secondary outcomes
Number of acute exacerbations within 1 year of drug withdrawal after 4 months of treatment
Number of acute exacerbations within 2 years after 4 months of treatment
Treatment response rate at 8 weeks
Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis
Sponsors and contacts
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