A Study to Evaluate the Effectiveness of a Drug (MEDI-563) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults
|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|
- 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.
- 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:||November 2010|
|Study Completion Date:||July 2013|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227278
Show 31 Study Locations
|Study Director:||Rene van der Merwe, MBChB||MedImmune Ltd|