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

Withdrawn

• Conditions: asthma; shortness of breath; 10001708; 10006436

• Registration Number: NL-OMON49549
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• 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, for whom 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
high-dose 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

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
* 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>