Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis (NCT07530770) | Clinical Trial Compass
RecruitingNot Applicable
Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis
China20 participantsStarted 2025-09-01
Plain-language summary
An open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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 equivalen…