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Effectiveness and Safety of Benralizumab in Allergic Bronchopulmonary Aspergillosis (ABPA) A Prospective Study of Real-world Experience
Led by Qianfoshan Hospital · Updated on 2026-04-21
20
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of benralizumab in treating patients with severe asthma complicated by allergic bronchopulmonary aspergillosis (ABPA). This open-label study aims to assess the real-world effectiveness and safety of benralizumab for this condition, focusing on reducing asthma exacerbations requiring steroids and improving patient quality of life. Participants will receive benralizumab injections every 4 weeks for the first three doses, followed by a fourth injection given eight weeks later, totaling 16 weeks of active treatment. After completing treatment, participants will have a follow-up visit eight weeks after the last injection, with the study's termination visit occurring at week 24. During the study, participants will have their asthma exacerbations requiring steroids tracked over 26 weeks as the primary outcome. Secondary outcomes include quality of life measured by the Saint George Respiratory Questionnaire, asthma control assessed by the Asthma Control Questionnaire 6, and lung function evaluated by FEV1. Participants who discontinue early will complete the termination procedures. The total study participation lasts approximately 24 weeks from the first treatment dose.
CONDITIONS
Brief Title
Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female and male patients aged 18 to 75 years at the time of Visit 1
- Physician diagnosis of Allergic Bronchopulmonary Aspergillosis meeting ISHAM Working Group Diagnostic Criteria
- Bronchial asthma as predisposing condition
- Positive Type I aspergillus skin test or elevated IgE level against Aspergillus fumigatus, niger, or flavus
- Elevated total IgE levels (greater than 1,000 IU/mL) or acceptable lower IgE if other criteria met
- At least two of three: presence of precipitating or IgG antibodies against Aspergillus fumigatus, radiographic pulmonary opacities consistent with ABPA, total eosinophil count above 500 cells/uL in steroid-naive patients
- Severe chronic asthma for at least 12 months requiring high dose ICS plus asthma controller prior to Visit 1
- Current treatment with high daily doses of ICS (greater than 500 ug FP equivalent) plus at least one other asthma controller for at least 3 months prior to Visit 1
- History of at least 2 asthma exacerbations requiring systemic corticosteroids in the 12 months prior to Visit 1
- Weight greater than 40 kg
You will not qualify if you...
- Clinically important pulmonary diseases other than asthma with ABPA such as COPD, cystic fibrosis, sarcoid, and pulmonary fibrosis
- History of anaphylaxis to any biologic therapy
- Known allergy or hypersensitivity to benralizumab or its components
- Current smokers or former smokers with more than 10 pack years smoking history
- Pregnant, breastfeeding, or lactating women
- Concurrent enrollment in another interventional or post-authorization safety study unless observational
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 - 16 weeks
Participants receive benralizumab injections every 4 weeks for the first 3 injections, followed by an additional injection 8 weeks later for a total of 16 weeks of active treatment.
4 injection visits (in-person)
Duration - 8 weeks
Participants attend a termination visit 8 weeks after the last injection to complete all study procedures and assessments.
1 follow-up visit (in-person)
Trial Site Locations
Total: 2 locations
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
2
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
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
1
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