FAsenra Safety Trial in India - FAST

Exclusion Criteria

• 1. Clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis etc.) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome), which can confound the outcome assessment.
• 2. Patients currently enrolled in an interventional clinical study in parallel including those with any biologic treatment
• 3. Patients who have received any biologic within 30 days prior to the date of informed consent.
• 4. Known history of allergy or reaction to the benralizumab formulation or excipients (L-histidine, L-histidine hydrochloride monohydrate, α-trehalose dihydrate, polysorbate 20, water for injection)
• 5. History of anaphylaxis to any biologic therapy
• 6. A helminth parasitic infection diagnosed within 24 weeks before the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
• 7. Acute asthma exacerbation 30 days before the date informed consent
• 8. Acute asthma exacerbation between screening and first dose of study dose administration.
• 9. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days before the date informed consent
• 10. Patients with malignancy within 5 years prior to enrolment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal, or squamous cell carcinoma or non-melanomatous skin cancer with active or recent malignancy
• 11. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis, which, in the opinion of the investigator, may put the participant at risk because of his/her participation in the study
• 12. History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the participant’s full participation in the study, in the opinion of the investigator
• 13. Female patients who are pregnant or lactating or planning a family during the study period.