Efficacy and safety study of benralizumab added to high-dose inhaled corticosteroid plus LABA in patients with uncontrolled asthma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1134

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures
2. Female and male aged 18 to 75 years inclusively 3. History of physician diagnosed asthma requiring treatment with medium to high dose inhaled corticosteroids (greater than 250 microgrammes fluticasone dry powder formulation equivalents total daily dose) and a LABA for at least 12 months prior to visit 1
4. Documented treatment with high dose inhaled corticosteroids (greater than 500 microgrammes fluticasone dry powder formulation equivalents total daily dose) and LABA for at least 3 months prior to visit 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1077
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

Exclusion Criteria

1. Clinically important pulmonary disease other than asthma (e.g active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hyperventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliarydyskinesia) 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 impairement 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 study or their interpretations, or impede the patients 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 patients ability to complete the entire duration of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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