RecruitingNCT07362667

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

A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With Allergic Bronchopulmonary Aspergillosis


Sponsor

Qianfoshan Hospital

Enrollment

44 participants

Start Date

Jan 10, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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;
  • Pregnant or lactating women;
  • Currently participating in other interventional clinical research;
  • 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).

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Interventions

PROCEDUREThe 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.


Locations(1)

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

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NCT07362667


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