Phase IV, Single-Center, Open-Label Study Evaluating the Effects of an Anti-IL5 Receptor Alpha (Benralizumab) Monoclonal Antibody in the Treatment of Severe Asthma in Patients With Allergic Bronchopulmonary Aspergillosis
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Baylor Research Institute
- Locations
- 1
- Primary Endpoint
- Number of steroid requiring exacerbations
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Fasenra, 30 Mg/mL Subcutaneous Solution (Drug)
Outcomes
Primary Outcomes
Number of steroid requiring exacerbations
Time Frame: 26 Weeks
Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe asthma complicated by ABPA
Secondary Outcomes
- Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire(26 Weeks)
- Lung Function (FEV1)(26 Weeks)
- Asthma Control as assessed by Asthma Control Questionnaire 6(26 Weeks)