Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist
Condition: Asthma
MeSH terms: Asthma
Intervention: Benralizumab; Placebo
Intervention description: Benralizumab subcutaneously on study week 0 until study week 52 inclusive.; Placebo subcutaneously on study week 0 until study week 52 inclusive.
Intervention MeSH terms: Benralizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2508.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases

Summary:

      The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate
      in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA
      with or without oral corticosteroids and additional asthma controllers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent prior to any study specific procedures

          2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1

          3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS
             (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA,
             for at least 12 months prior to Visit 1.

          4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or
             without oral corticosteroids and additional asthma controllers. The ICS and LABA can
             be parts of a combination product or given by separate inhalers. The ICS dose must be
             greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or
             equivalent daily. For ICS/LABA combination preparations, the mid-strength approved
             maintenance dose in the local country will meet this ICS criterion.

        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