Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Benralizumab; Placebo
Intervention description: Benralizumab subcutaneously on study week 0 until study week 44 inclusive.; Placebo subcutaneously on study week 0 until study week 44 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: 2681.0
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 number of asthma
      exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent for study participation must be obtained prior to any study
             related procedures being performed (local regulations are to be followed in
             determining the assent/consent requirements for children and parent[s]/guardian[s])
             and according to international guidelines and/or applicable European Union guidelines.

          2. Female and Male aged 12 to 75 years inclusively, at the time of visit 1. For those
             patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be
             considered an adolescent for the purposes of this trial.

          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.

               -  For subjects 18 years of age and older, the ICS dose must be >500 mcg/day
                  fluticasone propionate dry powder formulation or equivalent daily.

               -  For subjects ages 12-17, the ICS dose must be ≥500 mcg /day fluticasone
                  propionate dry powder formulation or equivalent daily.

        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