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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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

Key facts

Study ID: NCT01227278
Run by: MedImmune LLC
People needed: 421
Starts: 2010-11-01
Expected to finish: 2013-07-01
Last updated by the study team: 2016-10-05

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Research Site — Los Angeles, California, United States
Research Site — Marietta, Georgia, United States
Research Site — Normal, Illinois, United States
Research Site — Brooklyn, New York, United States
Research Site — Oklahoma City, Oklahoma, United States
Research Site — Greenville, South Carolina, United States
Research Site — Boerne, Texas, United States
Research Site — Tyler, Texas, United States
Research Site — Richmond, Virginia, United States
Research Site — Calgary, Alberta, Canada
Research Site — Hamilton, Ontario, Canada
Research Site — Québec, Quebec, Canada
Research Site — Saskatoon, Saskatchewan, Canada
Research Site — Århus C, Denmark
Research Site — Hellerup, Denmark
Research Site — København NV, Denmark
Research Site — Odense C, Denmark
Research Site — Frankfurt, Germany
Research Site — Mainz, Germany
Research Site — Gdansk, Poland
Research Site — Krakow, Poland
Research Site — Lodz, Poland
Research Site — Warsaw, Poland
Research Site — Barcelona, Spain
Research Site — Lleida, Spain

Full record on ClinicalTrials.gov

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