Benralizumab in the Treatment of Patients With Severe Asthma With ABPA

Phase 4

Withdrawn

• Conditions: ABPA; Severe Asthma; Allergic Bronchopulmonary Aspergillosis
• Interventions: Drug: Fasenra, 30 Mg/mL Subcutaneous Solution

• Registration Number: NCT04108962
• Lead Sponsor: Baylor Research Institute

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 Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Study Start: 2019-12-23
• Primary Completion: 2021-09-24
• Study Completion: 2021-10-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Fasenra, 30 Mg/mL Subcutaneous Solution	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

Primary Outcome Measures

Name	Time	Method
Number of steroid requiring exacerbations	26 Weeks	Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe asthma complicated by ABPA

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire	26 Weeks	The change from baseline score in Saint George Respiratory Questionnaire
Lung Function (FEV1)	26 Weeks	The FEV1 change from baseline to End of Treatment
Asthma Control as assessed by Asthma Control Questionnaire 6	26 Weeks	The change from baseline score in Asthma Control Questionnaire 6

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States