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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQianfoshan Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Procedure/Surgery

    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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Observation group1 intervention
Group B: Control group0 interventions

Trial outcomes

Primary outcomes

1

Radiographic response rate after 4 months of treatment

Radiographic remission: defined as the removal of mucus plugs in the airway on radiographic examination

Time frame
4 months
2

Immunological remission rate after 4 months of treatment

Immunological remission: defined as at least a 50% decrease in total serum IgE from baseline

Time frame
4 months
3

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

Time frame
4 months

Secondary outcomes

1

Number of acute exacerbations within 1 year of drug withdrawal after 4 months of treatment

Time frame
1 year
2

Number of acute exacerbations within 2 years after 4 months of treatment

Time frame
2 years
3

Treatment response rate at 8 weeks

Time frame
8 weeks
4

Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis

Time frame
2 years

Other outcomes

Sponsors and contacts

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