drugset / Trial / NCT01227278
A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
RandomizedParallel-groupDouble-blindTreatment
Summary
To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults.
Timeline
- Start
- 2010-11
- Primary completion
- 2013-01
- Completion
- 2013-07
Outcome
Missed primary endpoint
registry Placebo vs Benralizumab 100 mg; p = 0.941; Rate ratio 1.03 (95% CI 0.67 to 1.58); Van Elteren Test NCT01227278 ↗
paper Benralizumab did not reduce the annualised rate of acute exacerbations of COPD compared with placebo PMID 25208464 ↗
Publications
- Sridhar S, Liu H, Pham TH, Damera G, Newbold P. Modulation of blood inflammatory markers by benralizumab in patients with eosinophilic airway diseases. Respir Res. 2019 Jan 18;20(1):14. doi: 10.1186/s12931-018-0968-8.
- Brightling CE, Bleecker ER, Panettieri RA Jr, Bafadhel M, She D, Ward CK, Xu X, Birrell C, van der Merwe R. Benralizumab for chronic obstructive pulmonary disease and sputum eosinophilia: a randomised, double-blind, placebo-controlled, phase 2a study. Lancet Respir Med. 2014 Nov;2(11):891-901. doi: 10.1016/S2213-2600(14)70187-0. Epub 2014 Sep 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benralizumab | Monoclonal antibody | 100 mg | Subcutaneous |