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Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History

NCT02155660 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2255

Last updated 2019-06-26

Study results available
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Summary

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.

Conditions

  • Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Interventions

DRUG

Benralizumab Arm A

Benralizumab subcutaneously on study week 0 until study week 48 inclusive

DRUG

Benralizumab Arm B

Benralizumab subcutaneously on study week 0 until study week 48 inclusive

DRUG

Benralizumab Arm C

Benralizumab subcutaneously on study week 0 until study week 48 inclusive

DRUG

Placebo

Benralizumab subcutaneously on study week 0 until study week 48 inclusive

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Bartolome R. Celli, MD · Brigham and Women's Hospital, Pulmonary Division, 75 Francis Street, PBB Clinics 3, Boston, MA 02115

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-25
Primary Completion
2018-04-09
Completion
2018-04-09

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Chile
  • Colombia
  • Croatia
  • Denmark
  • France
  • Israel
  • Mexico
  • New Zealand
  • Norway
  • Peru
  • Philippines
  • Poland
  • Serbia
  • Slovenia
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • Vietnam

Study Locations

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Entities

Drugs
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 NCT02155660 on ClinicalTrials.gov