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The effect of stepping down asthma therapy in clinically stable children on exercise induced asthma.


- candidate number6560
- NTR NumberNTR2045
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-okt-2009
- Secondary IDsStepdown1 Medisch Spectrum Twente
- Public TitleThe effect of stepping down asthma therapy in clinically stable children on exercise induced asthma.
- Scientific TitleThe effect of Stepping-down from LABA/ICS combination therapy to ICS monotherapy on exercise and mannitol challenge tests in asthmatic children.
- ACRONYMstep-down exercise studie
- hypothesisWe hypothesized that in a subgroup of patients EIBH would improve after the cessation of LABA.
- Healt Condition(s) or Problem(s) studiedAsthma, Exercise induced Asthma
- Inclusion criteria1. 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 criteria1. Asthma exacerbation in past 3 months;
2. FEV 1 < 70% of predicted normal value.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 11-jan-2009
- planned closingdate1-jan-2010
- Target number of participants20
- InterventionsPatients 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 outcomeFall in FEV1 after exercise.
- Secondary outcomeScore on asthma control questionnaire baseline FEV1.
- TimepointsAn exercise challenge test and asthma control questionnaire are performed before and four weeks after the medication change.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Elin Kersten
- CONTACT for SCIENTIFIC QUERIES Elin Kersten
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente, Enschede
- PublicationsN/A
- Brief summaryThe 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)
- RECORD7-okt-2009 - 4-nov-2009


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