Bronchoscopic airway clearance with amphotericin B spraying for 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
This study will try bronchoscopic airway clearance plus amphotericin B spraying to see if it helps adults with allergic bronchopulmonary aspergillosis (ABPA) who have mucus plugs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07362667 on ClinicalTrials.gov |
What this trial studies
This single-center observational study in Jinan, China treats adults with ABPA who have mucus plugs using bronchoscopic airway clearance followed by topical amphotericin B spraying. Eligible participants meet ISHAM diagnostic criteria and have mucus plugs or hyperattenuated mucus confirmed on high-resolution chest CT, with active disease or recent exacerbation. The protocol records clinical symptoms, total serum IgE, radiographic changes, and procedure-related adverse events over follow-up. Safety and tolerability of bronchoscopy and antifungal spraying are prospectively monitored.
Who should consider this trial
Good fit: Adults (≥18 years) with ABPA by ISHAM criteria who have mucus plugs or hyperattenuated mucus on HRCT and active disease or acute exacerbation are the intended candidates.
Not a fit: Patients without radiographic mucus plugs, children under 18, or those unable to undergo bronchoscopy because of comorbidities or anesthesia risk are unlikely to benefit.
Why it matters
Potential benefit: If successful, the procedure could more rapidly clear mucus plugs, improve breathing and symptoms, and potentially reduce reliance on prolonged systemic therapies.
How similar studies have performed: Small case series support bronchoscopic removal of mucus plugs in ABPA, but topical amphotericin B spraying is relatively novel and has limited published evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Jinan, Shandong
- 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 (Recruiting)
Study contacts
- Study coordinator: Qian Qi, Dr.
- Email: qiqianqlh@163.com
- Phone: +86 13706380314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.