A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT01227278 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2016-10-05

Study results available
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Summary

To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

OTHER

Placebo

Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).

BIOLOGICAL

Benralizumab 100 mg

Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY
  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Rene van der Merwe, MBChB · MedImmune Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-01-31
Completion
2013-07-31

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Entities

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 NCT01227278 on ClinicalTrials.gov