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

Study identifier:D3250C00020

ClinicalTrials.gov identifier:NCT02075255

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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)

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

-

Sex

All

Actual Enrollment

220

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 28 Apr 2014
Primary Completion Date: 08 Aug 2016
Study Completion Date: 08 Aug 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 May 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria