Paediatric Patients with Severe Eosinophilic Asthma Asthma is a long-term lung disorder that causes airways (the tubes that carry air in and out of the lungs) to become inflamed. Patients with severe asthma are likely to have high levels of eosinophils in their blood. Eosinophils are a type of white blood cell that can cause inflammation and can increase the number of asthma attacks and contribute to the decline of lung function.
Conditions
Brief summary
Time to first asthma exacerbation defined as a worsening of asthma requiring: • Use of systemic corticosteroid (or a temporary increase) for at least 3 days; a single depo-injectable dose, OR • An emergency room visit due to asthma OR • Hospitalisation due to asthma
Detailed description
Change from baseline, during the DB treatment period, in the following measures: ACQ-IA, Asthma symptom score, Rescue medication use, Night-time awakenings due to asthma, PEF, • Serum benralizumab trough concentration • Anti-benralizumab antibodies, Change from baseline, during the DB treatment period, in PAQLQ-IA total score, Change from baseline, during the DB treatment period, in spirometry, including pre-dose/pre-bronchodilator FEV1 and post-bronchodilator FEV1, The AAER in the DB treatment period, Safety: AEs/SAEs : Occurrence/frequency ; Relationship to the IP as assessed by the investigator ; Intensity ; Seriousness ; Death ; AEs leading to discontinuation of IP ; Vital signs ; Clinical laboratory parameters, the Open-Label Extension;Period: AEs and SAEs, the Open-Label Extension: The AAER in the OLE period
Interventions
DRUGBenralizumab
DRUGPlacebo for Benralizumab 30 mg/ml for clinical trials is a sterile liquid solution
presented in an accessorized prefilled syringe (APFS) for subcutaneous injection.
The Placebo accessories are the same as the commercial APFS configuration.
Each syringe contains 1.0 mL (nominal).
DRUGPlacebo for Benralizumab for clinical trials is a sterile liquid solution presented in
an accessorized prefilled syringe (APFS) for subcutaneous injection.
Sponsors
Astrazeneca AB
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first asthma exacerbation defined as a worsening of asthma requiring: • Use of systemic corticosteroid (or a temporary increase) for at least 3 days; a single depo-injectable dose, OR • An emergency room visit due to asthma OR • Hospitalisation due to asthma | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline, during the DB treatment period, in the following measures: ACQ-IA, Asthma symptom score, Rescue medication use, Night-time awakenings due to asthma, PEF, • Serum benralizumab trough concentration • Anti-benralizumab antibodies, Change from baseline, during the DB treatment period, in PAQLQ-IA total score, Change from baseline, during the DB treatment period, in spirometry, including pre-dose/pre-bronchodilator FEV1 and post-bronchodilator FEV1, The AAER in the DB treatment period, Safety: AEs/SAEs : Occurrence/frequency ; Relationship to the IP as assessed by the investigator ; Intensity ; Seriousness ; Death ; AEs leading to discontinuation of IP ; Vital signs ; Clinical laboratory parameters, the Open-Label Extension;Period: AEs and SAEs, the Open-Label Extension: The AAER in the OLE period | — |
Countries
France, Germany, Italy, Poland, Spain
Outcome results
None listed