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"Monitoring inhalation technique"


- candidate number17631
- NTR NumberNTR4555
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mei-2014
- Secondary IDsNL48729.044.14 
- Public Title"Monitoring inhalation technique"
- Scientific Title“What is the effect of filming and reviewing using an iPad in asthma management in children aged 6-18 years?”
- ACRONYM"Monitoring inhalation technique"
- hypothesisVideotaping and reviewing inhalation tecnique with the aid of an iPad improves asthma control in children from 6-18 years old.
- Healt Condition(s) or Problem(s) studiedAsthma, Inhalation technique
- Inclusion criteriaClinical history of asthma symptoms
Age 6-18 years
Ability to record and send videoclips of inhalation technique with an iPad.
Significant drop in FEV1 during an exercise challenge test (25-30%)
- Exclusion criteriaInability to operate an iPad
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- controlActive
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 10-mei-2014
- planned closingdate31-dec-2014
- Target number of participants40
- InterventionsThe use of an iPad to film and review the inhalation technique.
- Primary outcomeThe fall in FEV1 during an ECT, on a trampoline (6-12 year) or a treadmill (12-18 year), will be measured . The endpoint is the fall in FEV1at the ECT . The ECT performed on a treadmill is according to ATS/ERS recommendations. The ECT’s will be performed at the paediatric department. Children will run, nose clipped, on a treadmill with a 10% to 19, 5% slope, for 3 min period (7 times) with a heart rate at 80% of predicted maximum (210-age). The children less than 12 years perform the ECT on a trampoline. Children will be asked to jump 3 times 2 minutes on a trampoline with a heart rate at 80% of the predicted maximum (210-age).
- Secondary outcome• The use of Salbutamol in both groups, the children receive during visit 1 a Salbutamol inhaler for symptoms of breathlessness during the 4 weeks. This inhaler contains a counter that counts how many times the inhaler is used.
• The scores in critical errors of inhalation technique after 4 weeks treatment. Inhalation technique will be scored according to standardized inhalation protocols designed by the Lung Alliance Netherlands (LAN) for every inhalation device (see appendix).
• The symptom score endpoint will be the measured by the ACT; this is a questionnaire that is answered by caregivers(s) and the child. The first 4 questions must be answered by the child, the last three by the caregiver(s). Score below 20 points; the asthma is not likely to have been under control for the past 4 weeks. 20 points or more; the asthma was probably well under control over the last 4 weeks.
- TimepointsIf children do not send their videoclips for more than three consequetive days they have to return their iPad.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. B.J. Thio
- CONTACT for SCIENTIFIC QUERIESDr. B.J. Thio
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Stichting Pediatric Research Enschede
- Publications-
- Brief summaryThe main objective of this study is: to investigate the effect of filming and reviewing with an ipad of the inhalation technique on EIB and compare the results with standard care/treatment in children aged 6-18 years with uncontroled moderate to severe asthma. Furthermore we study the Salbutamol use, symptom score between the treatments groups and the relation between demonstrated inhalation technique in the clinic and the videotaped inhalation technique.
- Main changes (audit trail)
- RECORD1-mei-2014 - 26-mei-2014


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