Benralizumab in the Treatment of Patients With Severe Asthma With ABPA (NCT04108962) | Clinical Trial Compass
WithdrawnPhase 4
Benralizumab in the Treatment of Patients With Severe Asthma With ABPA
Stopped: Difficult to find eligible patients willing to participate.
United States0Started 2019-12-23
Plain-language summary
Phase IV, 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
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…