Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy
The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance OCS in systemic corticosteroid dependent patients with severe refractory asthma with elevated eosinophils.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) to Reduce Oral Corticosteroid Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy (ZONDA)
Actual Study Start Date: April 28, 2014
Primary Completion Date: August 8, 2016
Study Completion Date: August 8, 2016
Arms and Interventions:
- Experimental: Benralizumab Arm A
- Experimental: Benralizumab Arm B
- Placebo Comparator: Placebo
Category | Value |
---|---|
Date last updated at source | 2017-10-17 |
Study type(s) | Interventional |
Expected enrolment | 220 |
Study start date | 2014-04-28 |
Estimated primary completion date | 2016-08-08 |