Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe with Benralizumab Administered at Home

Study identifier:D3250C00029

ClinicalTrials.gov identifier:NCT02417961

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Open-Label, Functionality, Reliability, and Performance Study of an Accessorized Pre-filled Syringe with Home-administered Subcutaneous Benralizumab in Adult Patients with Severe Asthma (GREGALE)

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

-

Sex

All

Actual Enrollment

162

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 27 Apr 2015
Primary Completion Date: 14 Mar 2016
Study Completion Date: 14 Mar 2016

Study design

Allocation: N/A
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria