Pharmacogenetics Use For Further treatment Improvement in childre
- Conditions
- Asthmachronic airway obstruction1000170810006436
- Registration Number
- NL-OMON55682
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
- Between 6-18 years of age
- Doctor's diagnosis of asthma based on patient history, FEV1 reversibility >=
12% ever and/or bronchial hyperresponsiveness ever.
- Current asthma symptoms (based on ACT (>= 12 years) or c-ACT (< 12 years)
score <= 19
- ICS use >= 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 Dutch language
- Internet access at home, willing to fill in internet questionnaires
- active smoking
- congenital heart disease
- serious lung disease other than asthma
- LABA use in the past 6 months
- omalizumab use
- ICU admission in the previous year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Improvement of asthma control based on repeated measurement analysis of<br /><br>(childhood)-Asthma Control Test scores after 3 months. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Change in asthma control score at t=6 months, time to ACT >= 20 (continuous<br /><br>variable), change in asthma related quality of life scores, change in fatigue<br /><br>score, school absences, exacerbations (oral corticosteroids use, ER visits,<br /><br>hospital admissions), time to first exacerbation, amount of changes in therapy<br /><br>at t=3 months, change in lung function (FEV1 pre-and postbronchodilator) at t=3<br /><br>and t=6, change in FeNO at t=3 and t=6. </p><br>