|- candidate number||14952|
|- NTR Number||NTR4021|
|- ISRCTN||ISRCT wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-jun-2013|
|- Secondary IDs|| |
|- Public Title||De bescherming van salbutamol tegen inspiratoire luchtwegobstructie ten gevolge van inspanning bij astmatische kinderen|
|- Scientific Title||The protective effect of a single dose salbutamol against exercise induced inspiratory airflow obstruction in asthmatic children |
|- hypothesis||Profylactisch 200ugr salbutamol kan tot 50% beschermen tegen de inspiratoire luchtwegobstructie gemeten in MIF50 die bij de meerderheid van de astmatische kinderen met FEV1 daling tijdens/na inspanning optreedt.|
|- Healt Condition(s) or Problem(s) studied||Exercise induced Asthma, Inspiratory airflow obstruction|
|- Inclusion criteria||- Clinical history of EIB.|
- Age 8 till 16 years old.
- Ability to jump or run and perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%.
|- Exclusion criteria||- Exacerbation in the last 4 weeks prior to the ECT (hospital admission or use of systemic corticosteroids).|
- Use of long acting bronchodilators 24 hours before testing.
- Use of short acting bronchodilators 8 hours before testing.
- Use of leukotriene antagonists 24 hours before testing.
- Other pulmonary or cardiac disorder.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2013|
|- planned closingdate||1-mei-2014|
|- Target number of participants||15|
|- Interventions||Two exercise challenge test (older children perform this test on a treadmill, younger children on a jumping castle). 15 minutes prior to the test children inhale either 200ugr salbutamol or a placebo.|
|- Primary outcome||The protective effect of a single regular dose of salbutamol compared with a placebo against inspiratory airflow obstruction in asthmatic children aged 8 till 16 years old. |
|- Secondary outcome||The relation between the protective effect of salbutamol against inspiratory airflow obstruction and EIB. |
|- Timepoints||t= 0: exercise challenge test 1.
t= 1week later: exercise challenge test 2.
Placebo or salbutamol in randomized order.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. R. Visser|
|- CONTACT for SCIENTIFIC QUERIES||Drs. R. Visser|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Stichting pediatrisch onderzoek Enschede|
|- Brief summary||Exercise induced bronchoconstriction (EIB) is a highly frequent and specific symptom of asthma and also the most bothersome as reported by asthmatic children. Exercise challenge tests (ECT) can identify EIB and are therefore frequently used to diagnose and evaluate asthma. Salbutamol provides excellent protection against EIB, however in daily life prophylactic salbutamol does not always prevent exercise induced symptoms in asthmatic children. A recent study demonstrated that the majority of children with EIB have besides expiratory also inspiratory airflow obstruction. This means that exercise can induce narrowing of the larger airways, possibly as a response to EIB. It is not known to what extent salbutamol can reduce this inspiratory airflow obstruction. Main objective of this study is to investigate if salbutamol protects against inspiratory airflow obstruction. |
|- Main changes (audit trail)|
|- RECORD||4-jun-2013 - 16-sep-2013|