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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01227278
First received: October 21, 2010
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
COPD
 Drug: MEDI-563
Other: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: February 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
Placebo SC injection every 28 days (first 3 doses) and every 56 days for (next 5 doses).
Active Comparator: MEDI-563 Drug: MEDI-563
SC injection every 28 days (3 doses) and every 56 days for the next (5 doses).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227278

  Show 56 Study Locations
Sponsors and Collaborators
MedImmune LLC
AstraZeneca
Investigators
Study Director: Rene van der Merwe, MBChB MedImmune Ltd
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01227278     History of Changes
Other Study ID Numbers: MI-CP196, 2010-020127-52
Study First Received: October 21, 2010
Last Updated: March 11, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013