Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Benralizumab; Placebo
Intervention description: Benra 30 mg q.4 Weeks is a fixed 30 mg dose of benralizumab subcutaneously on study week 0 until study week 44 inclusive.
Benra 30 mg - Placebo q.8 Weeks is a fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administrated at the 4 week interim visits to maintain blind). It is subcutaneously administered 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: 13.0
Sex: All
Minimum age: 18 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 medium doses of ICS-LABA.
    

Eligibility criteria:

        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