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Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

NCT01947946 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-11-24

Study results available
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Summary

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.

Conditions

Interventions

BIOLOGICAL

Benralizumab

Benra 30 mg q.4 Weeks is a fixed 30 mg dose of benralizumab subcutaneously on study week 0 until study week 44 inclusive. Benra 30 mg - Placebo q.8 Weeks is a fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administrated at the 4 week interim visits to maintain blind). It is subcutaneously administered on study week 0 until study week 44 inclusive.

BIOLOGICAL

Placebo

Placebo subcutaneously on study week 0 until study week 44 inclusive.

Sponsors & Collaborators

Principal Investigators

  • William W. Busse, MD · Allergy, Pulmonary and Critical Care Medicine, Clinical Science Center 600 Highland Ave, Madison, WI USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Germany
  • Poland
  • Russia

Study Locations

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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 NCT01947946 on ClinicalTrials.gov