Benralizumab treatment for adults with ABPA and severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm observational study enrolls adults with physician-diagnosed severe asthma and ABPA who meet ISHAM diagnostic criteria. Participants receive benralizumab injections at weeks 0, 4, 8 and 16, with a termination/follow-up visit at week 24 to capture outcomes. The study collects real-world clinical measures including symptoms, exacerbations, corticosteroid use, eosinophil counts, IgE levels, and pulmonary function or imaging when available. There is no randomized control group and both safety signals and effectiveness outcomes will be monitored during follow-up.

Why it matters

Who can join: the full rules

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 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 Criteria:

* 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.

Where it's running

• 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 Recruiting
• Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Qian Qi, Dr.
• Email: qiqianqlh@163.com
• Phone: +86 13706380314

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ML-based ABPA recurrence predictor in adults with ABPA

  A machine-learning model is being tested to see if it can predict the chance of an ABPA flare within a year in adults with ABPA during a stable phase.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07714863

• Fungal status and prognosis in ABPA: looking at who improves based on fungal tests

  This study checks if ABPA patients with positive or negative fungal tests in sputum or BALF have different outcomes over a year.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07690345

• Biologic treatment for adults with ABPA and severe asthma

  This project will test whether biologic medicines help adults with ABPA who have severe asthma and elevated eosinophils.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07362693

• Bronchoscopic airway clearance with amphotericin B spraying for ABPA

  This study will try bronchoscopic airway clearance plus amphotericin B spraying to see if it helps adults with allergic bronchopulmonary aspergillosis (ABPA) who have mucus plugs.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07362667

• Predicting response to Benralizumab in severe asthma patients

  This study is testing if a specific blood test can help predict how well people with severe asthma will respond to the medication Benralizumab.

  Recruiting at 15 sites Phase 4 Nantes University Hospital · Aix-en-Provence and 19 other locations · NCT04565483

• Benralizumab in EGPA: real-world effectiveness and safety

  This is a real-world study checking how well and safely benralizumab works for adults with eosinophilic granulomatosis with polyangiitis (EGPA).

  Recruiting European EGPA Study Group · Florence, Italy · NCT07815886

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.