To determine whether variation of PEF and FEV1 in children, using an electronic home spirometer, adds to the confirmation or rejection of the diagnosis asthma in children when suspected.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Daily variation of PEF and FEV1 between the asthma and non asthma group and
within the asthma group before and after the start of inhaled corticosteroids.
Secondary outcome
The cut-off point with the highest likelyhood ratio (sensitivity/1-specificity)
for the golden standard of asthma diagnosis
(pediatrician/pediatric-pulmonologist diagnosed asthma) wil be determined by
performing receiver operating ratio (ROC)-analyses. This analysis is primarily
'pilot' based. The estimated power will be to low for definit conclusions.
Background summary
The diagnosis asthma in school-aged children is primarily based on history and
physical examination. In a clinical practice lung function measurements are
commonly used to support the diagnosis. The downside of lung function tests is
that they only provide a snapshot impression of the lung function, rather than
reflect the variability of lung function in a variable disease as asthma. This
variability of lung function can be measured using portable peak flow
(PEF)-meters. In the past, this was done using mechanical PEF-meters and
hand-written diaries. Due to large overlap between healthy and asthmatic
children, PEF variation is not commonly used anymore as a diagnostic tool in
asthma. Research has shown, however, that mechanical PEF-meters and
hand-written diaries are unreliable. Previous work from our group showed that
healthy children using electronic PEF meters (recording value, time and date on
a micro-chip) had significantly lower reference values for PEF variability than
previously described, while well treated children with mild to moderate
persistent asthma showed quite high variability in lung function. From these
data, the hypothesis emerged that electronic home spirometers can be helpful in
diagnosing asthma in children.
Study objective
To determine whether variation of PEF and FEV1 in children, using an electronic
home spirometer, adds to the confirmation or rejection of the diagnosis asthma
in children when suspected.
Study design
This study will investigate the diagnostic value of PEF and FEV1 variation
(diagnostic test) in childhood asthma. The gold standard for the diagnosis
asthma will be: asthma diagnosed by a pediatrician or pediatric pulmonologist
based on international guidelines (GINA), using results from history, physical
examination and lung function tests (flow-volume curves before and after
broncho-dilators, fractional exhaled nitric oxide and methacholine challenge),
as is usual practice in the Isala Klinieken. The pediatrician or pediatric
pulmonologist will be blinded for the results of the home spirometry. After the
diagnosis asthma is confirmed (or rejected), the influence of inhaled
corticosteroids (when appropriate) on home spirometry will be assessed.
Intervention
During the first phase none. When asthma is diagnosed, inhaled corticosteroids
will be prescribed.
Study burden and risks
A slight worsening of symptoms may occur during the wash-out phase in some
children. However, due to the strict inclusion and exclusion criteria, this is
very unlikely to occur.
dokter van Heesweg 2
8000 GK Zwolle
Nederland
dokter van Heesweg 2
8000 GK Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
- schoolchildren reffered to the pediatric out-patient clinic for diagnostics of exclusion of asthma
- age 6-16 years
- 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
- refferal of children with an established diagnosis of asthma, who remain symptomatic despite treatement with inhaled corticosteroids.
- respiratory tract infection or use of systemic corticosteroids 4 weeks prior to the start of the study
- participation in another study
- use of systemic corticosteroids or 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 | NL14801.075.06 |