Pharmacogenetics Use For Further treatment Improvement in childreN

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21847

Enrollment

310

Registered

2017-09-29

Start date

2018-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Uncontrolled asthma, LABA response heterogeneity Ongecontroleerd astma, LABA respons heterogeniteit

Interventions

Participants will be randomized to 1) a genotype-guided treatment arm or 2) a usual care (non-genotype guided) control arm. In the genotype guided arm, children will be treated based on their genotype

Eligibility

Inclusion criteria

Inclusion criteria: - Between 6-18 years of age - Doctor's diagnosis of asthma based on FEV1 reversibility >= 12% ever and/or bronchial hyperresponsiveness ever - Current asthma symptoms (based on ACT (>= 12 years) or C-ACT (= 3 months before inclusion (start dosage ICS, treatment step 2 according to childhood asthma guideline NVK) - Adequate inhalation technique - Self-assessed good adherence to maintenance asthma treatment - Understanding of the Dutch language - Internet access at home, willing to fill in internet questionnaires

Exclusion criteria

Exclusion criteria: - Active smoking - Congenital heart disease - Serious lung disease other than asthma (Cystic Fibrosis, Primairy Ciliary Dyskinesia, congenital lung disorders, severe immune disorders, severe trancheamalacia) - LABA use in past 6 months - Omalizumab use - ICU admission in the previous year

Design outcomes

Primary

Measure	Time frame
Improvement of asthma control based on repeated measurement analysis of (childhood)-Asthma Control Test after 3 months	—

Secondary

Measure	Time frame
- Improvement of asthma control based on repeated measurement analysis of (childhood)-Asthma Control Test after 6 months - time to ACT >= 20 - change in asthma-related quality of life scores - change in fatigue score - school absences - exacerbations (oral corticosteroids use, ER visits, hospital admissions) - time to first exacerbation - amount of changes in therapy at t=3 months - change in lung function (FEV1 pre- and postbronchodilator) at t=3 and t=6 months - change in FeNO at t=3 and t=6 months - change in nasal gene expression and nasal gene methylation in relation to the treatment effect at t=3 and t=6 months - Incremental cost per Quality Adjusted Life Year (QALY) - Incremental costs per avoided exacerbation	—

Measure

Time frame

- Improvement of asthma control based on repeated measurement analysis of (childhood)-Asthma Control Test after 6 months - time to ACT >= 20 - change in asthma-related quality of life scores - change in fatigue score - school absences - exacerbations (oral corticosteroids use, ER visits, hospital admissions) - time to first exacerbation - amount of changes in therapy at t=3 months - change in lung function (FEV1 pre- and postbronchodilator) at t=3 and t=6 months - change in FeNO at t=3 and t=6 months - change in nasal gene expression and nasal gene methylation in relation to the treatment effect at t=3 and t=6 months - Incremental cost per Quality Adjusted Life Year (QALY) - Incremental costs per avoided exacerbation

—

Contacts

Public ContactA.H. Maitland-van der Zee

a.h.maitland@amc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)