Diagnostic value diurnal peak flow and FEV1 variation assessed electronically with home spirometry in childhood asthma.
Completed
- Conditions
- asthma10006436
- Registration Number
- NL-OMON30702
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Daily variation of PEF and FEV1 between the asthma and non asthma group and<br /><br>within the asthma group before and after the start of inhaled corticosteroids. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The cut-off point with the highest likelyhood ratio (sensitivity/1-specificity)<br /><br>for the golden standard of asthma diagnosis<br /><br>(pediatrician/pediatric-pulmonologist diagnosed asthma) wil be determined by<br /><br>performing receiver operating ratio (ROC)-analyses. This analysis is primarily<br /><br>'pilot' based. The estimated power will be to low for definit conclusions.</p><br>