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Exercise induced bronchoconstriction in 5 till 7 year old children with asthma.


- candidate number10278
- NTR NumberNTR3038
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-aug-2011
- Secondary IDsP11-29 METC
- Public TitleExercise induced bronchoconstriction in 5 till 7 year old children with asthma.
- Scientific TitleEIB in 5-7 year olds.
- ACRONYMEIB 5-7
- hypothesisThe aim of this study is to investigate the course of EIB in young asthmatic children, by using a newly designed exercise provocation challenge.
- Healt Condition(s) or Problem(s) studiedAsthma, Exercise induced Asthma, Exercise induced bronchoconstriction
- Inclusion criteria1. Clinical history of asthma symptoms;
2. Age 5 till 7 years;
3. Ability to perform reproducible lung function tests;
4. Clinically stable period at least 4 weeks before the study period (no hospital admission or use of systemic corticosteroids).
- Exclusion criteria1. Use of systemic corticosteroids in the last 4 weeks prior to the study;
2. Use of long acting bronchodilators 24 hours before testing;
3. Use of short acting bronchodilators 8 hours before testing;
4. Use of leukotriene antagonists 24 hours before testing;
5. Other pulmonary or cardiac disorder.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2011
- planned closingdate1-apr-2012
- Target number of participants50
- InterventionsNo intervention, other than the exercise provocation challenge, will be investigated. An exercise provocation challenge is part of the routine clinical evaluation of patients with exercise induced symptoms or asthma. However, an exercise provocation challenge in the evaluation of asthmatic children aged 5 till 7 years isnít widely used and can therefore be seen as an intervention. Moreover, our newly designed exercise provocation challenge, using a jumping castle is experimental. Thus the intervention used in our study is a newly designed exercise provocation challenge.
This exercise provocation challenge exists of jumping on a jumping castle for at least 4 minutes (target is a 6 minute lasting exercise at 80% of the predicted maximum heart rate). Before, during and after exercise, patients perform pulmonary function measurements (flow volume curves).
- Primary outcomeMain objective of this study is the measurement of pulmonary function (change in FEV1, FEV0.5 and FEF50) during and post-exercise in young children with asthmatic features. Thus the percent change in pulmonary function (FEV1, FEV0.5 and FEF50) during and post-exercise.
- Secondary outcome1. Analysis of anthropometric measures, clinical features, medication use and history (measured by extensive history) of children with a positive or negative exercise provocation challenge;
2. Analysis of the feasibility of a newly designed exercise provocation challenge using a jumping castle.
- TimepointsOne visit.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES J.C. Leeuwen, van
- CONTACT for SCIENTIFIC QUERIES J.C. Leeuwen, van
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Stichting Pediatrisch Onderzoek Enschede
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD24-aug-2011 - 25-sep-2011


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