Asthma MedDRA version: 14.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: benralizumab
Product Code: medi-563
Pharmaceutical Form:
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcuta
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the effect of two dosing regimens of benralizumab on asthma exacerbations in adult patients with uncontrolled asthma;Secondary Objective: To assess the effect of two dosing regimens of benralizumab on: Pulmonary function Asthma symptoms and other asthma control metrics Emergency room visits and hospitalisations due to asthma Pharmacokinetics and immunogenicity Safety and tolerability;Primary end point(s): Annual asthma exacerbation rate;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Pre-dose/pre-bronchodilator FEV1 and post-bronchodilator FEV1 at the study centre 2. Asthma symptom score (total, daytime and night time), rescue medication use, home lung function (morning and evening PEF), nights with awakening due to asthma, ACQ-6 3. Annual rate of exacerbations associated with an emergency room visit or hospitalisation 4. PK parameters and anti-drug antibodies 5. AE/SAE, laboratory variables, ECG, physical examination;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Countries
Australia, Brazil, Bulgaria, Czech Republic, France, Italy, Korea, Republic of, Mexico, Peru, Poland, Russian Federation, South Africa, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactAZ Clinical Study Information
AstraZeneca AB
Outcome results
None listed