Recruiting NCT07362667
A Study of the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With ABPA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The patients were treated with bronchoscopic airway clearance and amphotericin B spraying.
- Who it may be relevant to
- Registry conditions: ABPA, Allergic Bronchopulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis (ABPA), Airway Clearance. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
To evaluate the efficacy and safety of bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis
Interventions
- Procedure The 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.
Primary outcome measures
- Radiographic response rate after 4 months of treatment [Time frame: 4 months]
- Immunological remission rate after 4 months of treatment [Time frame: 4 months]
- The remission rate of clinical symptoms after 4 months of treatment [Time frame: 4 months]
Secondary outcome measures (11)
- Number of acute exacerbations within 1 year of drug withdrawal after 4 months of treatment [Time frame: 1 year]
- Number of acute exacerbations within 2 years after 4 months of treatment [Time frame: 2 years]
- Treatment response rate at 8 weeks [Time frame: 8 weeks]
- Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis [Time frame: 2 years]
- Time from discontinuation to first exacerbation [Time frame: 2 years]
- After drug withdrawal, the number of patients who achieved treatment remission [Time frame: 2 years]
- Quality of life score (AQLQ or mini-AQLQ) [Time frame: 2 years]
- Serum total IgE [Time frame: 2 years]
- All-cause mortality [Time frame: 2 years]
- psychological Scale (Hospital Anxiety and Depression Scale, HADS) [Time frame: 2 years]
- Aspergillus fumigatus sIgE [Time frame: 2 years]
Eligibility criteria
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;
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Respiratory, The First Affiliated Hospital of Shandong First Medical Univers — Jinan
Identifiers
NCT: NCT07362667 · ABPA-001