Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis

NCT07530770 | Recruiting FDA Drug

• 1 other identifier: ABPA-003
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

An open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis

Conditions

Allergic Bronchopulmonary Aspergillosis; Severe Asthma; ABPA

Keywords

ABPA; Benralizumab

Outcome Measures

Primary Outcomes (1)

• Number of steroid requiring exacerbations

  Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe asthma complicated by ABPA

  26 Weeks

Secondary Outcomes (3)

• Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire

  26 Weeks

• Asthma Control as assessed by Asthma Control Questionnaire 6

  26 Weeks

• Lung Function (FEV1)

  26 Weeks

Study Arms (1)

Experimental: Treatment

Benralizumab treatment will be given by injections administered every 4 weeks for the first 3 injections with an additional injection eight weeks to follow for a total of 16 weeks active treatment

Drug: Fasenra

Interventions

Fasenra DRUG

30 Mg/mL Subcutaneous Solution

Also known as: Benralizumab

Experimental: Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 Severe chronic asthma (for at least 12 months) requiring treatment with high dose ICS plus asthma controller prior to Visit 1 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

You may qualify if:

• 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.
• Weight \> 40kg

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (2)

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, 250014, China

RECRUITING

Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250014, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary; Asthma

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive

Study Officials

• Qian Qi

  Shandong First Medical University

  STUDY DIRECTOR

Central Study Contacts

Qian Qi, Dr.

CONTACT

+86 13706380314; qiqianqlh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: April 15, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)