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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthmatics | Experimental | Patients receive anti-IL5 treatment as part of their prescribed routine. Immunological and clinical parameters will be evaluated at the start of the treatment and after 6 months of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab Injection [Nucala] | Drug | Patients receive monthly injection with 100 mg mepolizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Airway inflammation | 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). | Day 1 and after 6 months |
| Change in Forced Expiratory Volume in 1 seconds (FEV1) | The forced expiratory Volume in 1 second will be measured using spirometry | Day 1 and after 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine pattern in the airways | Cytokines concentrations (pg/ml) will also be determined in sputum supernatant using a U-plex assay. | Day 1 and after 6 months |
| Cytokine pattern in the bloodstream |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatjana Decaesteker | KU Leuven | Principal Investigator |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
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Cytokines concentrations (pg/ml) will also be determined in serum using a U-plex assay.
| Day 1 and after 6 months |
| Change in asthma control | 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. | Day 1 and after 6 months |
| Biomarkers for airway inflammation | 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) | Day 1 and after 6 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |