A Study to Evaluate the Effectiveness of a Drug (MEDI-563) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
Information provided by (Responsible Party):
First received: October 21, 2010
Last updated: April 3, 2014
Last verified: April 2014
To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo
Placebo SC injection every 28 days (first 3 doses) and every 56 days for (next 5 doses).
Active Comparator: MEDI-563
SC injection every 28 days (3 doses) and every 56 days for the next (5 doses).
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.
|Ages Eligible for Study:
||40 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227278
||Rene van der Merwe, MBChB
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 21, 2010
||April 3, 2014
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 21, 2014
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases