Inhalation 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…
ID
Bron
Verkorte titel
Aandoening
Exercise Induced Asthma
Inspanningsastma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To 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).
Achtergrond van het onderzoek
Exercise 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.
Doel van het onderzoek
Inhalation 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.
Onderzoeksopzet
1. Patients inclusion: September - December 2013;
2. ECT's: October - January 2014.
Onderzoeksproduct en/of interventie
1. Interview with investigator about history, complaints and medication use;
2. Anthropometric measurements (height, weight);
3. Physical examination (pulmonary auscultation);
4. Two ECT’s, 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 µgr 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.
Publiek
Departement of pediatrics<br>
Haaksbergerstraat 55
R. Visser
Enschede 7513 ER
The Netherlands
+31 (0)53 4872310
R.Visser@mst.nl
Wetenschappelijk
Departement of pediatrics<br>
Haaksbergerstraat 55
R. Visser
Enschede 7513 ER
The Netherlands
+31 (0)53 4872310
R.Visser@mst.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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%.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3810 |
NTR-old | NTR3976 |
CCMO | NL44755.044.13 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |