Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma



Status:Terminated
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:November 2013
End Date:July 2014

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A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma

The purpose of this study is to determine whether Benralizumab reduces the number of asthma
exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.


Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures

2. Female and male aged from 18 to 75 years, inclusively

3. History of physician-diagnosed asthma requiring treatment with medium dose ICS
(>250ug fluticasone dry powder formulation equivalents total daily dose) and a LABA,
for at least 12 months prior to Visit 1

4. Documented treatment with medium-dose ICS (>250ug and ≤500ug fluticasone dry powder
formulation equivalents total daily dose) and LABA for at least 3 month prior to
Visit 1

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
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