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

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

Study Overview

• Status: Recruiting
• Conditions: Allergic Bronchopulmonary Aspergillosis; ABPA; Allergic Bronchopulmonary Aspergillosis (ABPA); Airway Clearance; Mucus Plug; Amphotericin B; Bronchoscope
• Intervention / Treatment: Procedure: The patients were treated with bronchoscopic airway clearance and amphotericin B spraying

• Study Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

• Study Contact: Name: Qian Qi, Dr.; Phone Number: +86 13706380314; Email: qiqianqlh@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
      • Contact: Qian Qi, Dr.; Phone Number: +86 13706380314; Email: qiqianqlh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		2 years
Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis		2 years
Serum total IgE		2 years
Aspergillus fumigatus sIgE		2 years
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
Time from discontinuation to first exacerbation		2 years
After drug withdrawal, the number of patients who achieved treatment remission	The remission phase was defined as sustained (>6 months) clinical-radiologic improvement in the absence of (or discontinuation of) glucocorticoid therapy and the absence of an increase in total serum IgE of 50% or more from the last recorded value during the stable phase	2 years
Quality of life score (AQLQ or mini-AQLQ)		2 years
psychological Scale (Hospital Anxiety and Depression Scale, HADS)		2 years

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 27, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Amphotericin B; ABPA; Airway Clearance; Allergic Bronchopulmonary Aspergillosis; bronchoscope; mucus plug
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Bacterial Infections and Mycoses; Lung Diseases, Fungal; Mycoses; Pulmonary Aspergillosis; Aspergillosis; Aspergillosis, Allergic Bronchopulmonary
• Other Study ID Numbers: ABPA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No