Pharmacogenetics Use For Further treatment Improvement in childre
- Conditions
- ncontrolled asthma, LABA response heterogeneity<br /><br />Ongecontroleerd astma, LABA respons heterogeniteit
- Registration Number
- NL-OMON21847
- Lead Sponsor
- Academic Medical Center (AMC)
- Brief Summary
Vijverberg SJ, Pijnenburg MW, Hövels AM, Koppelman GH, Maitland-van der Zee AH. The need for precision medicine clinical trials in childhood asthma: rationale and design of the PUFFIN trial. Pharmacogenomics. 2017;18(4):393-401.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 310
Inclusion Criteria
Between 6-18 years of age
- Doctor's diagnosis of asthma based on FEV1 reversibility >= 12% ever and/or bronchial hyperresponsiveness ever
Exclusion Criteria
- Active smoking
- Congenital heart disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of asthma control based on repeated measurement analysis of (childhood)-Asthma Control Test after 3 months
- Secondary Outcome Measures
Name Time Method - Improvement of asthma control based on repeated measurement analysis of (childhood)-Asthma Control Test after 6 months<br /><br>- time to ACT >= 20<br /><br>- change in asthma-related quality of life scores<br /><br>- change in fatigue score<br /><br>- school absences<br /><br>- exacerbations (oral corticosteroids use, ER visits, hospital admissions)<br /><br>- time to first exacerbation<br /><br>- amount of changes in therapy at t=3 months<br /><br>- change in lung function (FEV1 pre- and postbronchodilator) at t=3 and t=6 months<br /><br>- change in FeNO at t=3 and t=6 months<br /><br>- change in nasal gene expression and nasal gene methylation in relation to the treatment effect at t=3 and t=6 months<br /><br>- Incremental cost per Quality Adjusted Life Year (QALY) <br /><br>- Incremental costs per avoided exacerbation