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Het beschermende effect van een enkele gangbare dosis inhalatiesteroid op inspanningsastma uitgevoerd met verschillende lichaamshoudingen tijdens inhalatie.


- candidate number14813
- NTR NumberNTR3976
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-apr-2013
- Secondary IDsNL44755.044.13 CCMO
- Public TitleHet beschermende effect van een enkele gangbare dosis inhalatiesteroid op inspanningsastma uitgevoerd met verschillende lichaamshoudingen tijdens inhalatie.
- Scientific TitleThe protective effect of a single dose inhaled steroid with different body postures against exercise induced bronchoconstriction.
- ACRONYMBody postures
- hypothesisInhalation of a single regular dose steroid (200ugr Qvar autohaler) with a stretched upper airway (achieved by leaning forward and flexing the head backwards) will protect more against exercise induced asthma compared to inhalation of a single regular dose steroid with the standard inhalation technique.
- Healt Condition(s) or Problem(s) studiedExercise induced Asthma
- Inclusion criteria1. Clinical history of asthma symptoms;
2. Age 6 till 16 years;
3. Documented EIB <4weeks prior to the study as measured with an exercise challenge test;
4. Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%.
- Exclusion criteria1. Exacerbation in the last 4 weeks prior to the ECT (hospital admission or use of systemic corticosteroids);
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;
6. Use of oral/ nasal/inhaled corticosteroids <2months prior to the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate1-mei-2014
- Target number of participants38
- Interventions1. Interview with investigator about history, complaints and medication use;
2. Anthropometric measurements (height, weight);
3. Physical examination (pulmonary auscultation);
4. Two ECTís, which consists of either running on a treadmill for the older children or jumping on a jumping castle for the younger children for at least 4 minutes (maximum 6 minutes);
5. Four hours prior to each ECT children will inhale a single regular dose of 200 Ķgr BDP; one time with the standard body posture and head position and one time with the alternative forward leaning body posture with the head flexed backwards. Before inhalation they will perform baseline lungfunction measurements;
6. Pulmonary function measurements (flow volume curve) before (duplicated), during (twice) and after exercise at t= 1,2,3,5,7,10 and 15 minutes;
7. Parents or child will answer a short questionnaire regarding to the body posture during inhalation of their child.
- Primary outcomeTo investigate the protective effect of a single regular dose of an ICS inhaled with different body postures and head positions against EIB as measured with an ECT with pulmonary lung function measurements (FEV1 and FEV0.5).
- Secondary outcome1. Investigate if body posture and head position during medication inhalation effects inspiratory flow obstruction as measured with spirometry during and after an ECT in asthmatic children of > 12 years old;
2. Investigate with the aid of a questionnaire which body postures and head positions children commonly use during medication inhalation at home.
- Timepoints1. Patients inclusion: September - December 2013;
2. ECT's: October - January 2014.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. R. Visser
- CONTACT for SCIENTIFIC QUERIESDrs. R. Visser
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Stichting Pediatric Research of the Medisch Spectrum Twente
- PublicationsN/A
- Brief summaryExercise induced bronchoconstriction (EIB) is a highly specific and frequent 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 asthma and evaluate asthma treatment. EIB can be treated with inhaled medication; inhaled corticosteroids (ICS) offer long term and pre-exercise bronchodilators short term protection. However, a single high dose ICS has been observed to offer protection against EIB on a short term base as well. It is well known that the vast majority of inhaled particles do not reach their target, ie the small airways, but impact in the upper airway. Main objective of this study is to investigate if body posture and head position can influence clinical effects of inhaled medication.
- Main changes (audit trail)
- RECORD26-apr-2013 - 16-sep-2013


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