severe asthma
Conditions
Interventions
Fasenra is available as a solution for injection in pre-filled syringes and
pre-filled pens. It can only be obtained with a prescription and treatment
should be started by doctors with experience in
Sponsors
Longziekten
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients eligible for treatment with benralizumab will be aged 18 - 75 years and have a confirmed diagnosis of severe eosinophilic asthma according to ERS/ATS guidelines. 2. Pre-bronchodilator FEV1 of * 80% predicted and 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. 3. All patients will show persistent blood eosinophilia of >0.3 x 10E9/L despite treatment with high doses of inhaled corticosteroids (>500 ug/day fluticasone equivalent), or >0.15 x 10E9/L despite chronic oral corticosteroid treatment at baseline. 4. At least 2 documented asthma exacerbations in the 12 months prior to the date informed consent. 5. Females of childbearing potential must have a negative pre-treatment urine pregnancy test
Exclusion criteria
Exclusion criteria: 1. Current smokers or former smokers with a smoking history of >=15 pack years. A former smoker is defined as a subject who quit smoking at least 6 months prior to Visit 1 2. Chronic pulmonary disorders other than asthma 3. Current malignancy or previous malignancy in remission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in specific airway volume (siVaw) at FRC & TLC during treatment with benralizumab after 4 and 12 weeks · Absolute change in specific airway resistance (siRaw) at FRC & TLC during treatment with benralizumab after 4 and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in other FRI parameters (absolute change in values or percent predicted at baseline, after 4 and 12 weeks of treatment): • airway wall volume • air trapping • Internal Lobar Airflow Distribution • Image based lobe volumes 2. Change in spirometry parameters: FEV1, FVC,FEF 25-75, tiffeneau index (FEV1/FVC ratio), IC 3. Change in body plethysmography parameters: RV, TLC, FRC, Raw, Sraw, Sgaw 4. Change in FeNO (Fractional concentration of exhaled nitric oxide) 5. Change in FOT (Forced oscillation technique= measurement of airway impedance) 5. Change in Patient reported outcomes: ACQ, SGRQ 6. Change in exercise tolerance: 6MWT 7. Change in blood eosinophil count All other parameters will be evaluated at baseline, after 1 week, 4 weeks and 12 weeks of treatment, and correlated with changes in FRI parameters: | — |
Countries
Netherlands
Outcome results
None listed