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

NCT07362667 | Recruiting

• 1 other identifier: ABPA-001
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Allergic Bronchopulmonary Aspergillosis; ABPA; Amphotericin B; bronchoscope; Airway Clearance; mucus plug

Outcome Measures

Primary Outcomes (3)

• Radiographic response rate after 4 months of treatment

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

  4 months

• Immunological remission rate after 4 months of treatment

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

  4 months

• 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

  4 months

Secondary Outcomes (11)

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

  1 year

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

  2 years

• Treatment response rate at 8 weeks

  8 weeks

• Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis

  2 years

• Time from discontinuation to first exacerbation

  2 years

Study Arms (2)

Observation group

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

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

Control group

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.

Interventions

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

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.

Observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (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, 250014, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, sputum, bronchoalveolar lavage fluid, urine, stool

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Qian Qi, Dr.

CONTACT

+86 13706380314; qiqianqlh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 23, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)