Status:
WITHDRAWN
Benralizumab in the Treatment of Patients With Severe Asthma With ABPA
Lead Sponsor:
Baylor Research Institute
Conditions:
ABPA
Severe Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Phase IV, open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis
Detailed Description
Subjects who have been identified to have severe asthma with ABPA will be consented and enrolled in the study to receive benralizumab injections administered every 4 weeks for the first 3 injections w...
Eligibility Criteria
Inclusion
- SELECT 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
- SELECT 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.
Exclusion
Key Trial Info
Start Date :
December 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04108962
Start Date
December 23 2019
End Date
October 1 2021
Last Update
February 1 2022
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75246