asthma shortness of breath
Conditions
Interventions
Intervention (if applicable): the intervention is treatment with Nucala® (100
mg subcutaneously every 4 weeks/4 doses) or with placebo (saline, every 4
weeks/4 doses).
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age > 18 and younger than 70 years * Diagnosis of eosinophil asthma despite use of corticosteroids * Suitable for sputum induction * >2.5% sputum eosinophils OR blood eosinophils > 0.25x10^9/L
Exclusion criteria
Exclusion criteria: * Any acute or chronic infection (eg. HIV, Hepatitis, STDs, pneumonia, influenza etc.) * 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 immune modulating medication (such as NSAID's, monoclonal antibodies, purine antagonistis etc.) excluding: o Steroids used to treat asthma * exuberant alcohol consumption (for males > 36 glasses per week, for females >24 glasses per week) * Drug use * Active cancer or a cancer diagnosed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: the main study parameter is enrichment of 2H-DNA in the DNA of eosinophils obtained at different time points after labelling. The patients will be asked to drink 2H-glucose (1 g/kg) during 6 hrs at time -5 days before the start of the treatment. After 5 days labelled eosinophils will leave the bone marrow and the pulse of 2H-DNA can be followed in blood and sputum. The kinetics of the pulse relates with the half-life of the cells | — |
Secondary
| Measure | Time frame |
|---|---|
| The secundary parameters are: 1. Th17/Th2 cytokine profile in peripheral blood. Data will be determined by multiplex technology (Luminex) 2. Profile of eosinophil degranulation products in sputum samples. | — |
Countries
Netherlands
Outcome results
None listed