Asthma
Conditions
Brief summary
22 asthmatics, in which mepolizumab was to be started, gave permission for inclusion and were followed up prospectively. Clinical and lung functional data, sputum analyses and cytokine measurements were analyzed.
Interventions
DRUGMepolizumab Injection [Nucala]
Patients receive monthly injection with 100 mg mepolizumab
Sponsors
KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* FEV1 \< 80% in the last 12 months * use of high dose inhaled corticosteroids (ICS) in combination with other additional medication or continuous use of oral corticosteroids (OCS) * at least 2 exacerbations in the last 12 months * at least 300 blood eosinophils/µl once in the last 12 months and at the time of inclusion * Anti-IL5 treatment prescribed by the physician
Exclusion criteria
* Not completing all visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airway inflammation | Day 1 and after 6 months | Bronchial airway inflammation. Differential cell count will be performed on sputum samples, determining eosinophilic (\>3% eosinophils, \<61% neutrophils), neutrophilic (\<3% eosinophils and \>61% neutrophils), pauci-granulocytic (\<3% eosinophils and \<61% neutrophils) and mixed granulocytic airway inflammation (\>3% eosinophils and \>61% neutrophils). |
| Change in Forced Expiratory Volume in 1 seconds (FEV1) | Day 1 and after 6 months | The forced expiratory Volume in 1 second will be measured using spirometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cytokine pattern in the airways | Day 1 and after 6 months | Cytokines concentrations (pg/ml) will also be determined in sputum supernatant using a U-plex assay. |
| Cytokine pattern in the bloodstream | Day 1 and after 6 months | Cytokines concentrations (pg/ml) will also be determined in serum using a U-plex assay. |
| Change in asthma control | Day 1 and after 6 months | Asthma control will be determined using the Asthma Control Questionnaire (ACQ-6), including 6 questions. Each question will be scored from 0-6 and added together. This final score will be divided by the number of questions. If ACQ-6 \< 0.75 = controlled asthma, ACQ-6 from 0.75-1.5 = partly controlled asthma and ACQ-6 \> 1.5 = uncontrolled asthma. |
| Biomarkers for airway inflammation | Day 1 and after 6 months | Fraction exhaled Nitric Oxid (FeNO) will be used as biomarker for eosinophilic airway inflammation. FeNO \< 25 ppb = eosinophilic inflammation less likely, FeNO between 25 and 50 ppm = need further interpretation with additional clinical information, FeNO \> 50 ppm = indication of eosinophilic airway inflammation (according to the American Thoracic Society guidelines) |
Outcome results
None listed