Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

Exclusion Criteria

• 1. Clinically important pulmonary disease other than asthma (e.g. active lung
• infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis,
• hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin
• deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary
• or systemic disease, other than asthma, that are associated with elevated peripheral
• eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-
• Strauss syndrome, hypereosinophilic syndrome)
• 2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic,
• renal, neurological, musculoskeletal, infectious, endocrine, metabolic,
• haematological, psychiatric, or major physical impairment that is not stable in the
• opinion of the Investigator and could:
• - Affect the safety of the patient throughout the study
• - Influence the findings of the studies or their interpretations
• - Impede the patient’s ability to complete the entire duration of study
• 3. Acute upper or lower respiratory infections requiring antibiotics or antiviral
• medication within 30 days prior to the date informed consent is obtained or during
• the screening/run-in period
• 4. Any clinically significant abnormal findings in physical examination, vital signs,
• haematology, clinical chemistry, or urinalysis during screening/run-in period, which
• in the opinion of the Investigator, may put the patient at risk because of his/her
• participation in the study, or may influence the results of the study, or the patient’s
• ability to complete entire duration of the study