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ID
Bron
Verkorte titel
Aandoening
- Bronchiale aandoeningen (excl. neoplasmata)
Synoniemen aandoening
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
FEV1 en PEF tijdens de subjectieve benauwdheidsklachten.
Secundaire uitkomstmaten
n/a
Achtergrond van het onderzoek
Inhaled corticosteroids (ICS) are the cornerstone in asthma treatement, in
adults as well as in children. When acute dyspneu occors, direct symptom relief
is obtained by using B2 agonists. It is known that children with asthma and
their parents have often difficulty in recognising symptoms of dyspneu and it
is unknown wether the use of B2 agonists at home is due to an objective
decrease in lung function.
A simple and non-invasive way to assess variation of airways obstruction is the
use of home spirometry and peak flow (PEF) measurements. In contrast to
mechanical PEF-meters and written diaries, children show high adherence to
using electronic home spirometers. Results obtained by home spirometry show
good agreement with lung function measured in hospitals and are therefore
suitable to get an impression of the dergee and the variation of lung function
at times of subjective need for bronchodilators. With this study the nature of
the acute symptoms in pediatric asthma can be properly described.
Doel van het onderzoek
To see if there is a clinically relevant and statisticallly significant
decrease in lung function when children with mild to moderate persistent asthma
feel the need to take bronchodilators.
Onderzoeksopzet
At the beginning and at the end of the study bronchial obstruction and
reversibility of lung function will be assessed and exhaled NO will be
measured. A validated disease-specific quality of life questionnaire will also
be filled in. During the study, children will record a symptomscore (VAS-scale)
twice daily and, when feeling the need to take bronchodilators, just before
taking them. At these times, they also will measure PEF and FEV1 on a portable
spirometer. Once every 2 weeks these values will be downloaded on a PC.
Inschatting van belasting en risico
n/a
Publiek
dokter van Heesweg 2
8000 GK Zwolle
Nederland
Wetenschappelijk
dokter van Heesweg 2
8000 GK Zwolle
Nederland
Landen waar het onderzoek wordt uitgevoerd
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- schoolchildren with dokters' diagnosed asthma, monitored by a pediatrician.
- age 6-16 year
- familiar with the outpatient asthma clinic in Zwolle
- capable of performing reproducible lung function measurements at home
- proper understanding of the dutch language
- informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- other chronic or acute disease capable of influencing the study results
- airway tract infection or use of systemic corticosteroïds 4 weeks prior to the start of the study
- participation in another trial
- use of systemic corticosteroids and long-acting β2 sympathicomimetics.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
CCMO | NL14896.075.06 |