NCT01227278

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

A Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI-563 in Subjects With Moderate-to-severe Chronic Obstructive Pulmonary Disease and Sputum Eosinophilia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

To evaluate the effect of multiple subcutaneous (SC) doses of benralizumab (MEDI 563) on the rate of moderate-to-severe annualized incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with moderate-to-severe COPD who exhibit eosinophilia (greater than or equal to \[\>=\] 3.0 percent \[%\] sputum eosinophilia in the previous 12 months or at Screening) in sputum compared to placebo.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-01-01
• Completion: 2013-07-01
• First posted: 2010-10-25
• Last updated: 2016-10-05
• Results posted: 2016-10-05

Locations

31 sites across 7 countries: United States, Canada, Denmark, Germany, Poland, Spain, United Kingdom