Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History

Completed · Phase 3 · Has a placebo group

Conditions studied: Moderate to Very Severe Chronic Obstructive Pulmonary Disease

In brief

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.

Key facts

Study ID

NCT02155660

Run by

AstraZeneca

People needed

2255

Starts

2014-06-25

Expected to finish

2018-04-09

Last updated by the study team

2019-06-26

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
• Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety-study findings or their interpretation or subject's ability to complete the entire study duration.
• Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome.
• Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and run-in period.
• Acute upper or lower respiratory infection requiring antibiotics within 2 weeks prior to Visit1 or during the enrolment and run-in period.
• Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.
• Pregnant, breastfeeding, or lactating women.
• Risk factors for pneumonia
• History of anaphylaxis to any other biologic therapy.
• Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.
• Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.
• Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
• Evidence of active tuberculosis (TB) without an appropriate course of treatment.
• Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
• Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
• Previous treatment with benralizumab.
• Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.

Where it is running

• Research Site — Gulf Shores, Alabama, United States
• Research Site — Montgomery, Alabama, United States
• Research Site — Flagstaff, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Anaheim, California, United States
• Research Site — Arcadia, California, United States
• Research Site — Bakersfield, California, United States
• Research Site — Fresno, California, United States
• Research Site — Fullerton, California, United States
• Research Site — Hawaiian Gardens, California, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Northridge, California, United States
• Research Site — Palmdale, California, United States
• Research Site — Peninsula, California, United States
• Research Site — Placentia, California, United States
• Research Site — Rolling Hills Estates, California, United States
• Research Site — Westminster, California, United States
• Research Site — Centennial, Colorado, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Chiefland, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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