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

Qianfoshan Hospital

Status: Enrolling

Conditions: Airway Clearance; Allergic Bronchopulmonary Aspergillosis; Amphotericin B; ABPA; Mucus Plug; Allergic Bronchopulmonary Aspergillosis (ABPA); Bronchoscope

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

Study type: Observational

Funder types: Other

Identifiers

NCT07362667

ABPA-001

Details and patient eligibility

About

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

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

44 participants in 2 patient groups

Observation group

Description:

The observation group was treated with standard drug therapy (oral glucocorticoids combined or not combined with oral antifungal drugs), combined with bronchoscopic airway clearance and amphotericin B spraying treatment

Treatment:

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

Control group

Description:

Control group: The control group was treated with standard drug therapy (oral glucocorticoids with or without oral antifungal drugs). The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc.