Effect of Anti-interleukin 5 (IL5) Therapy on Sputum Cells and Cytokines

Study Overview
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Brief Summary
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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.

Conditions
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Asthma

Intervention / Treatment
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* Drug: Mepolizumab Injection [Nucala]


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asthmatics<br>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 | Drug: Mepolizumab Injection [Nucala]<br>* Patients receive monthly injection with 100 mg mepolizumab<br>* Other names: Anti-IL5 treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |