A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA - BORA

Study identifier:D3250C00021

ClinicalTrials.gov identifier:NCT02258542

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

-

Sex

All

Actual Enrollment

2133

Study type

Interventional

Age

12 Years - 75 Years

Date

Study Start Date: 19 Nov 2014
Primary Completion Date: 18 Oct 2017
Study Completion Date: 02 Jul 2018

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other

Verification:

Verified 01 Jul 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria