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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01227278
First received: October 21, 2010
Last updated: April 3, 2014
Last verified: April 2014

October 21, 2010
April 3, 2014
November 2010
July 2013   (final data collection date for primary outcome measure)
To evaluate multiple SC doses of MEDI 563 on the rate of moderate-to-severe acute exacerbations in COPD (AECOPD) in adult subjects. [ Time Frame: Study Day 393 ] [ Designated as safety issue: Yes ]
Testing the differences in number of moderate-to-severe AECOPDs between the MEDI-563 treatment group and the placebo group.
Same as current
Complete list of historical versions of study NCT01227278 on ClinicalTrials.gov Archive Site
Adverse Events and Severe Adverse Events will be categorically summarized by organ class and relationship to investigational product. [ Time Frame: Study Day 561 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Effectiveness of a Drug (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 COPD and Sputum Eosinophilia

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

To evaluate the effect of multiple subcutaneous (SC) doses of MEDI 563 on the rate of moderate-to-severe AECOPD in adult subjects with moderate-to-severe COPD who exhibit eosinophilia (≥ 3.0% sputum eosinophilia in the previous 12 months or at screening) in sputum compared to placebo.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
COPD
  • Drug: MEDI-563
    SC injection every 28 days (3 doses) and every 56 days for the next (5 doses).
  • Other: Placebo
    Placebo SC injection every 28 days (first 3 doses) and every 56 days for (next 5 doses).
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Active Comparator: MEDI-563
    Intervention: Drug: MEDI-563
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
421
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 AECOPD.
  • Current smoker or ex-smoker with a tobacco history of ≥ 10 pack-years.
  • Adequate contraception from screening through end of trial.
  • Able to read and write.

Exclusion Criteria:

  • 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 > 37.0°C (98.6°F) 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 (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.
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Denmark,   Germany,   Poland,   Spain,   United Kingdom
 
NCT01227278
MI-CP196, 2010-020127-52
No
MedImmune LLC
MedImmune LLC
AstraZeneca
Study Director: Rene van der Merwe, MBChB MedImmune Ltd
MedImmune LLC
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP