Phase IV, open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis
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 with an additional injection eight weeks to follow for a total of 16 weeks active treatment with a follow-up/termination visit eight weeks from the last injection. The termination visit will occur week 24 for subjects who complete the study treatment. Subjects who receive the first dose of benralizumab but withdraw from the study or terminate study treatment for any reason should complete all the procedures outlined for the termination visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Anti-IL5 receptor alpha monoclonal antibody
Baylor University Medical Center
Dallas, Texas, United States
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
Time frame: 26 Weeks
Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire
The change from baseline score in Saint George Respiratory Questionnaire
Time frame: 26 Weeks
Asthma Control as assessed by Asthma Control Questionnaire 6
The change from baseline score in Asthma Control Questionnaire 6
Time frame: 26 Weeks
Lung Function (FEV1)
The FEV1 change from baseline to End of Treatment
Time frame: 26 Weeks
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