Efficacy and safety of Benralizumab in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) with exacerbation history - TERRANOVA

Exclusion Criteria

• -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.