asthma shortness of breath
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
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/microl 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 on average 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 biopsies | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of eosinophils in the peripheral blood (million/ml) 2. Kinetics of eosinophils in tissue and blood. | — |
Countries
Netherlands
Outcome results
None listed