Status:
COMPLETED
A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
AstraZeneca
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief 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 o...
Eligibility Criteria
Inclusion
- Subjects aged 40-85 years at the time of Screening
- Written informed consent obtained from the subject prior to performing any protocol related procedures
- Documented history of 1 or more Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
- Current smoker or ex-smoker with a tobacco history of greater than or equal to (\>=) 10 pack-years
- Adequate contraception from screening through end of trial
- Able to read and write.
Exclusion
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Pregnant, breastfeeding, or lactating women
- Known history of allergy or reaction to any component of the investigational product formulation
- History of anaphylaxis to any other biologic therapy
- Donation or transfusion of blood, plasma or platelets within the past 3 months prior to Screening
- Other significant pulmonary disease which in the opinion of the investigator or medical monitor, might compromise the interpretation of the study
- Fever greater than (\>) 37.0 degree Centigrade (98.6 degree Fahrenheit) at Screening
- Receipt of any novel investigational medicinal product within 3 months before the first dose of investigational product in this study and through the end of the study
- Seropositive for hepatitis A, hepatitis B surface antigen, hepatitis C, or human immunodeficiency virus 1or 2 (HIV-1 or HIV 2)
- History of alcohol or drug abuse within the past year that required treatment that the investigator felt or medical monitor felt would compromise the study data interpretation
- Past or current malignancy within the past 5 years except adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than 1 year prior to Screening
- Subjects participating in, or scheduled for, an intensive COPD rehabilitation program (subjects who are in the maintenance phase of a rehabilitation program are eligible to take part)
- Current diagnosis of asthma according to Global Initiative for Asthma guidelines
- Previous treatment with MEDI-563.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT01227278
Start Date
November 1 2010
End Date
July 1 2013
Last Update
October 5 2016
Active Locations (31)
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1
Research Site
Los Angeles, California, United States
2
Research Site
Marietta, Georgia, United States
3
Research Site
Normal, Illinois, United States
4
Research Site
Brooklyn, New York, United States