Asthma MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
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 from 18 to 75 years, inclusively 3. History of physician-diagnosed asthma requiring treatment with medium dose ICS and a LABA 4. Elevated level of peripheral blood eosinophil 5. Documented treatment with high-dose ICS and LABA for at least 6 months prior to Visit 1 6. Chronic oral prednisone or prednisolone therapy for at least 6 continuous months directly preceding Visit 1, and on a stable dose for at least one month prior to Visit 1 7.Patients with documented failures of OCS reduction within 6 months prior to Visit 1 will not be required to proceed through the dose optimization phase during run-in. 8. Morning pre-bronchodilator (Pre-BD) FEV1 of =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts. 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 5. History of life-threatening asthma 6. Asthma control reached at an OCS dose of =5mg during run-in/OCS optimization phase 7. Qualifies for 3 consecutive dose reductions at Visits 2-4 and continues to meet OCS dose reduction criteria at Visit 5 8. Receipt of oral dexamethasone as the maintenance oral steroid controller for asthma symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The effect of 2 dosing regimens of benralizumab on percentage reduction of Oral Corticosteroid dose in the terms of percentage reduction in final Oral Corticosteroid dose compared with week 0, while maintaining asthma control;Secondary Objective: To assess the effect of 2 dosing regimens of benralizumab on: -OCS dose in adult patients with uncontrolled asthma -parameters associated with asthma exacerbations -pulmonary function -asthma symptoms and other asthma control metrics ;Primary end point(s): Percentage reduction in final OCS dose compared with baseline (Visit 6), while maintaining asthma control;Timepoint(s) of evaluation of this end point: Week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The effect of 2 dosing regimens of benralizumab on: -OCS dose in terms of proportion of patients with =50% reduction in average daily OCS dose at week 28 compared with dose at week 0 while maintaining asthma control average final OCS dose =5.0 mg daily at week 28, while maintaining asthma control. -OCS dose in terms of proportion of patients with =5.0 mg reduction on daily OCS dose at week 28 compared with dose at week 0, while maintaining asthma control. -Proportion of patients with =1 asthma exacerbation after randomization, time to the first asthma exacerbation after randomization and annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization after randomization -pulmonary function in terms of change from week 0 in prebronchodilator Forced Expiratory Volume in 1 second (FEV1) and in prebronchodilator Inspiratory Capacity (IC), Expiratory Reserve Volume (ERV) and Inspiratory Reserve Volume (IRV). -asthma symptoms and other asthma control metrics in the terms of change from week 0 in asthma symptom score (total, daytime, and night time) and in rescue medication use. -asthma symptoms and other asthma control metrics in the terms of change from week 0 in the number of nights with awakening due to asthma requiring rescue medication. - asthma symptoms and other asthma control metrics in the terms of change from week 0 in Asthma Control Questionnaire 6 (ACQ-6). -asthma related health related quality of life in the terms of change from week 0 in Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12). -The pharmacokinetics (PK) of 2 dosing regimens of benralizumab in the terms of PK parameters -The immunogenicity of 2 dosing regimens of benralizumab in the terms of Anti-drug antibodies (ADA) presence or absence -The safety and tolerability of 2 dosing regimens of benralizumab in terms of Adverse Event (AE)/Serious Adverse Event (SAE) -The safety and tolerab | — |
Countries
Argentina, Bulgaria, Canada, Chile, France, Germany, Poland, Spain, United States
Contacts
Public ContactClinical Trial Transparency
AstraZeneca AB
Outcome results
None listed