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Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

NCT01914757 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2508

Last updated 2017-01-25

Study results available
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Summary

The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.

Conditions

Interventions

BIOLOGICAL

Benralizumab

Benralizumab subcutaneously on study week 0 until study week 52 inclusive.

BIOLOGICAL

Placebo

Placebo subcutaneously on study week 0 until study week 52 inclusive.

Sponsors & Collaborators

Principal Investigators

  • Mark Fitzgerald, MD, PhD, Professor of Medicine · The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Germany
  • Japan
  • Philippines
  • Poland
  • Romania
  • Sweden
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01914757 on ClinicalTrials.gov