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.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
FEV1 and PEF when children have respiratory symptoms and take bronchodilators.
Secondary outcome
n/a
Background summary
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.
Study objective
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.
Study design
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.
Study burden and risks
n/a
dokter van Heesweg 2
8000 GK Zwolle
Nederland
dokter van Heesweg 2
8000 GK Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
- 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
Exclusion criteria
- 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14896.075.06 |