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What is the effect of an antibody directed against IL-5 (Mepolizumab) in the inflammatory reaction in asthmatic patients


- candidate number26985
- NTR NumberNTR6354
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mrt-2017
- Secondary IDs2016-001636-35 
- Public TitleWhat is the effect of an antibody directed against IL-5 (Mepolizumab) in the inflammatory reaction in asthmatic patients
- Scientific TitleDual homing mechanisms of eosinophils to the sputum; only one of which is sensitive for mepolizumab
- ACRONYMFOOTSTEP
- hypothesisEosinophils play an important role in the inflammatory processes in the lung of asthmatic patients. Mepolizumab inhibits homing of these cells. The hypothesis is tested that mepolizumab affects the kinetics of these cells in blood and sputum.
- Healt Condition(s) or Problem(s) studiedEosinophilic asthma, Action of mepolizumab on lung inflammation
- Inclusion criteriaAge>18 and younger than 70 years
Diagnosis of eosinophil asthma despite use of corticosteroids suitable for sputum induction
>2.5 % sputum eosinophils
- Exclusion criteriaAny infection (e.g. HIV, hepatitis, STD's)
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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 14-feb-2017
- planned closingdate31-dec-2018
- Target number of participants20
- InterventionsMepolizumab
- Primary outcomechange in kinetics of eosinophils in the sputum
- Secondary outcomechange in kinetics of eosinophils in the sputum
change in systemic cytokines
change in sputum markers for presence of eosinohils
- Timepointsthree time points for sputum induction/analysis
10 time points for blood sampling/analysis
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. L. Koenderman
- CONTACT for SCIENTIFIC QUERIESProf. Dr. L. Koenderman
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD31-mrt-2017 - 5-jun-2017


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