A Study of the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying … (NCT07362667) | Clinical Trial Compass
RecruitingNot Applicable
A Study of the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With ABPA
China44 participantsStarted 2026-01-10
Plain-language summary
To evaluate the efficacy and safety of bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
✕. Combined with other diseases requiring long-term systemic use of glucocorticoids or immunosuppressants (such as autoimmune diseases);
✕. Patients with previous or current smoking history;
What they're measuring
1
Radiographic response rate after 4 months of treatment
Timeframe: 4 months
2
Immunological remission rate after 4 months of treatment
Timeframe: 4 months
3
The remission rate of clinical symptoms after 4 months of treatment