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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:


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 ]

Enrollment: 421
Study Start Date: November 2010
Study Completion Date: July 2013
Primary Completion Date: July 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 31 Study Locations
Sponsors and Collaborators
MedImmune LLC
AstraZeneca
Investigators
Study Director: Rene van der Merwe, MBChB MedImmune Ltd
  More Information

Additional Information:
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: April 3, 2014
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 April 17, 2014