Actively Recruiting
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
Led by Qianfoshan Hospital · Updated on 2026-01-23
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of bronchoscopic airway clearance combined with amphotericin B spraying for patients with allergic bronchopulmonary aspergillosis (ABPA). This study compares this procedure along with standard drug therapy against standard therapy alone, aiming to improve treatment outcomes such as symptom remission and immunological response. The study is observational and involves patients diagnosed with active ABPA, including newly diagnosed cases or acute exacerbations. Participants in the observation group will receive standard drug treatment, which includes oral glucocorticoids with or without oral antifungal drugs, along with bronchoscopic airway clearance and amphotericin B spraying. The control group will receive only the standard drug therapy while maintaining previous asthma treatments like inhaled corticosteroids and long-acting beta-agonists. The bronchoscopic procedure is performed based on mucus plug removal effectiveness and is given at least once. Both groups continue their usual asthma medications. Participants will be monitored for radiographic response, immunological remission, and clinical symptom remission after 4 months of treatment. Additional outcomes include acute exacerbations, hospitalizations, quality of life, immunological markers, psychological assessments, and mortality tracked up to 2 years. The study includes imaging, blood tests, and symptom evaluations to assess treatment effects and safety over time. The total participation period includes treatment and long-term follow-up for comprehensive outcome measurement.
CONDITIONS
Brief Title
A Study of the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With ABPA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with allergic bronchopulmonary aspergillosis according to ISHAM guidelines (2024 revision) and confirmed mucus plugs or hyperattenuated mucus on chest CT
- Active disease with newly diagnosed ABPA or acute exacerbation after stopping treatment, including clinical worsening or CT progression and at least 50% increase in serum IgE
- Age 18 years or older
You will not qualify if you...
- ABPA serotype with no obvious chest CT abnormalities
- Contraindications to electronic bronchoscopy
- Allergy to amphotericin B or its ingredients
- Bronchiectasis caused by HIV, active tuberculosis, lung cancer, or other non-ABPA causes
- Other diseases requiring long-term systemic glucocorticoids or immunosuppressants
- History of smoking
- Pregnant or breastfeeding women
- Participation in other interventional clinical trials
- Any condition that may prevent study participation, such as severe mental illness or predicted survival under 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 months
Participants receive standard drug therapy with oral glucocorticoids with or without oral antifungal drugs. In the observation group, participants also undergo bronchoscopic airway clearance and amphotericin B spraying at least once in addition to their usual asthma treatments.
Visits occur during the 4 months treatment period
Duration - Up to 2 years
After treatment ends, participants are monitored for up to 2 years to observe acute exacerbations, hospitalizations, treatment remission, quality of life, and other health outcomes.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
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, China, 250014
Actively Recruiting
Research Team
Q
Qian Qi, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here