Benralizumab for severe asthma in people with allergic bronchopulmonary aspergillosis
Observes how benralizumab works in adults with allergic bronchopulmonary aspergillosis and severe asthma.
Plain-language title generated from the registry record
Registry title: Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis
Key facts
- Where
- Jinan, ChinaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07530770, who can take part
Where in China
- Department of Respiratory, The First Affiliated Hospital of Shandong First Medical UniversityJinan, ChinaTaking people
- Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, ChinaJinan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qianfoshan Hospital
- Trial code
- NCT07530770
- Record updated
- 21 April 2026
- Original description
An open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosisRead full original descriptionShow less
Effectiveness and Safety of Benralizumab in Allergic Bronchopulmonary Aspergillosis (ABPA): a Prospective Study of Real-world Experience
An open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis
Inclusion: Female and Male patients aged 18-75 years inclusively at the time of Visit 1 with a physician diagnosis of Allergic Bronchopulmonary Aspergillosis has met the ISHAM Working Group Diagnostic Criteria for ABPA:; Predisposing condition: Bronchial asthma Obligatory criteria (both should be present); Type I aspergillus skin test positive (immediate cutaneous hypersensitivity Aspergillus antigen) or elevated IgE level against Aspergillus fumigatus (Af) Aspergillus niger or Aspergillus flavus may be eligible provided antigen-specific IgE and IgG measurements are available for use; Elevated total IgE levels (>1,000IU/mL)* Other criteria (at least two of three); Presence of precipitating or IgG antibodies against Af in serum Radiographic pulmonary opacities consistent with ABPA Total eosinophil count >500 cells/uL in steroid naïve patients (may be historical); (if the patient meets all other criteria, an IgE value <1,000 IU/mL may be acceptable) Severe chronic asthma (for at least 12 months) requiring treatment with high dose ICS plus asthma controller prior to Visit 1; Other acceptable asthma controllers include long acting bronchodilators (e.g. a long acting beta-agonist (LABA) or long-acting muscarinic antagonists (LAMA)), a leukotriene inhibitor, theophylline preparations and/or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control Documented current treatment with high daily doses of ICS ( >500ug of FP equivalent) plus at least one other asthma controller for at least 3 months prior to Visit 1; For ICS/LABA combination preparation, highest-strength maintenance doses approved in the U.S. will meet this criterion If the ICS and the other asthma controller therapies are given by separate inhalers, then the patient must be on a high daily ICS dose for 3 months prior to entering the study; History of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples) that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving oral corticosteroids as a maintenance therapy, an exacerbation is defined as a temporary increase of their maintenance dose for a minimum of 3 days; Weight > 40kg.
Exclusion: Clinical important pulmonary disease other than asthma with allergic bronchopulmonary aspergillosis (ie. chronic obstructive pulmonary disease (COPD), cystic fibrosis, sarcoid, and pulmonary fibrosis) History of anaphylaxis to any biologic therapy Known history of allergy or hypersensitivity reaction to benralizumab or any of its components Current smokers or former smokers with a smoking history of > 10 pack years. A former smoker is defined as a patient who quit smoking at least 6 months prior to Visit 1; Currently pregnant, breastfeeding, or lactating women Concurrent enrollment in another interventional or post-authorization safety study, unless it is observational.