|- candidate number||6560|
|- NTR Number||NTR2045|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-okt-2009|
|- Secondary IDs||Stepdown1 Medisch Spectrum Twente|
|- Public Title||The effect of stepping down asthma therapy in clinically stable children on exercise induced asthma.|
|- Scientific Title||The effect of Stepping-down from LABA/ICS combination therapy to ICS monotherapy on exercise and mannitol challenge tests in asthmatic children.|
|- ACRONYM||step-down exercise studie|
|- hypothesis||We hypothesized that in a subgroup of patients EIBH would improve after the cessation of LABA.
|- Healt Condition(s) or Problem(s) studied||Asthma, Exercise induced Asthma|
|- Inclusion criteria||1. Children aged 8-16 yrs;|
2. History of allergic asthma and EIBH;
3. Clinically stable asthma;
4. Treatment with a combination LABA/ICS;
5. FEV1 70% of predicted normal value.
|- Exclusion criteria||1. Asthma exacerbation in past 3 months;|
2. FEV 1 < 70% of predicted normal value.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||11-jan-2009|
|- planned closingdate||1-jan-2010|
|- Target number of participants||20|
|- Interventions||Patients who's medication is stepped down from LABA/ICS combinationtherapy to ICS monotherapy are monitored by an exercise challenge test before and after the medication change.|
|- Primary outcome||Fall in FEV1 after exercise.
|- Secondary outcome||Score on asthma control questionnaire
|- Timepoints||An exercise challenge test and asthma control questionnaire are performed before and four weeks after the medication change.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Elin Kersten|
|- CONTACT for SCIENTIFIC QUERIES|| Elin Kersten|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Medisch Spectrum Twente, Enschede|
|- Brief summary||The Netherlands.|
The effect of stepping down therapy from ICS/LABA combination therapy to ICS monotherapy on exercise induced asthma is studied. 20 children whose medication is stepped down according to clinical practice guidelines are monitored with an exercise challenge test before and 4 weeks after their medication change. Baseline FEV1 and fall in FEV1 after the exercise challenge are measured and compared.
|- Main changes (audit trail)|
|- RECORD||7-okt-2009 - 4-nov-2009|