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Diagnostic value diurnal peak flow and FEV1 variation assessed electronically with home spirometry in childhood asthma.

Diagnostic value diurnal peak flow and FEV1 variation assessed electronically with home spirometry in childhood asthma. - Electronical Peak flow and Lung function Monitoring 6 (EPLM 6)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30702
Enrollment
60
Registered
2007-02-01
Start date
2007-03-06
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma

Interventions

During the first phase none. When asthma is diagnosed, inhaled corticosteroids will be prescribed.

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)