*Differences in effect of treatment with mepolizumab and benralizumab on resident and inflammatory eosinophils

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 72

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, forwhom 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
highdose 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

Inclusion criteria healthy controls
• Age >= 18 and matching age and sex of the population of asthma patients

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
o acetylsalicylic acid 0-2 days before the start of the study
• 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of eosinophils per high power field in rectal biopsies</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Number of eosinophils in the peripheral blood (million/ml)<br /><br>2. Kinetics of eosinophils in tissue and blood.</p><br>

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