Severe eosinophilic asthma
Conditions
Interventions
Mepolizumab en benralizumab
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age = 18 • Diagnosis of severe refractory eosinophilic asthma • Eligible for mepolizumab or benralizumab therapy according the national recommendations for severe asthma of the Dutch society for lung diseases and tuberculosis (NVALT guideline 2013): Patients with asthma, for whom alternative diagnoses are excluded, comorbidity optimally treated, provoking factors minimized and therapy compliance optimized, but despite this still have insufficient asthma control (= 1.5 ACQ-7 or other questionnaire) or frequent (=2 annually) severe exacerbations (systemic CS needed) while routinely using high-dose asthma medication (= 1000 mcg/day fluticasone propionate equivalent and/or daily OCS in combination with LABA or other controller medication); or patients who can achieve asthma control only with systemic CS and are therefore are risk for adverse effects or the corticosteroids. • Treated with mepolizumab or benralizumab for at least 4 months. • Before treatment with biologics a blood eosinophilia (= 150 eosinophils/?l blood) irrespective of steroid use
Exclusion criteria
Exclusion criteria: • Any infection (eg. HIV, Hepatitis, STDs) • Insulin dependent diabetes • Smoking at present or in the last 12 months and/or a past history of more than 10 pack years • Proven allergic bronchopulmonary aspergillosis • Auto-immune diseases • Use of medication, excluding: o Anticonceptives o Pain killers, if used less than once a week • exuberant alcohol consumption (for males > 36 glasses per week, for females >24 glasses per week) • Drug use • History of cancer • Use of biologicals other than mepolizumab or benralizumab • daily oral steroid therapy during the three months preceding inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of eosinophils per high power field in rectal tissue | — |
Secondary
| Measure | Time frame |
|---|---|
| Kinetics of tissue eosinophils determined by metabolic labeling with deuterated glucose | — |
Contacts
Public ContactLeo Koenderman
UMC Utrecht
Outcome results
None listed