DUAL HOMING MECHANISMS OF EOSINOPHILS TO THE SPUTUM; ONLY ONE OF WHICH IS SENSITIVE FOR MEPOLIZUMAB

Completed

Conditions: asthma
shortness of breath
10006436

Registration Number: NL-OMON45761

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

* Age > 18 and younger than 70 years
* Diagnosis of eosinophil asthma despite use of corticosteroids
* Suitable for sputum induction
* >2.5% sputum eosinophils OR blood eosinophils > 0.25x10^9/L

Exclusion Criteria

* Any acute or chronic infection (eg. HIV, Hepatitis, STDs, pneumonia, influenza etc.)
* 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 immune modulating medication (such as NSAID's, monoclonal antibodies, purine antagonistis etc.) excluding:
o Steroids used to treat asthma
* exuberant alcohol consumption (for males > 36 glasses per week, for females >24 glasses per week)
* Drug use
* Active cancer or a cancer diagnosed < 5 years ago.
* Unstable disease despite high dose of systemic steroids (20 mg prednisolon or more)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: the main study parameter is enrichment of<br /><br>2H-DNA in the DNA of eosinophils obtained at different time points after<br /><br>labelling. The patients will be asked to drink 2H-glucose (1 g/kg) during 6 hrs<br /><br>at time -5 days before the start of the treatment. After 5 days labelled<br /><br>eosinophils will leave the bone marrow and the pulse of 2H-DNA can be followed<br /><br>in blood and sputum. The kinetics of the pulse relates with the half-life of<br /><br>the cells </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary parameters are:<br /><br><br /><br>1. Th17/Th2 cytokine profile in peripheral blood. Data will be determined by<br /><br>multiplex technology (Luminex)<br /><br>2. Profile of eosinophil degranulation products in sputum samples.</p><br>