nbiased BIOmarkers for the Prediction of REspiratory Disease outcomes: understanding severe asthma in childre
- Conditions
- asthma10038716
- Registration Number
- NL-OMON36534
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 65
Severe school aged asthma cohort: 6-17yrs old, persistent asthma symptoms or frequent severe exacerbations or persistent airflow limitation despite the prescription of high dose ICS or prescription of maintenance OCS
Mild-moderate school aged asthma cohort: 6-17yrs old, controlled asthma symptoms (according to GINA guidelines) with the prescription of low to moderate dose ICS
Severe pre school wheeze cohort: 1-5yrs old, persistent symptoms or frequent severe exacerbations despite the prescription of high dose ICS (or failed trial) or prescription of maintenance OCS
Mild-moderate pre school wheeze cohort: 1-5yrs old, controlled symptoms (according to GINA guidelines) with the prescription of low to moderate dose ICS (or failed trial).
See protocol page 35 to 40 for protocol specific inclusion criteria.
1. As a result of medical interview, physical examination or screening investigation the responsible physician considers the child unfit for the study.
2. The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
3. Subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. If a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses
4. The child has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. Any U-BIOPRED assessments should be deferred until 3 months after the first dose or invasive procedure. Permission from the Scientific Board must be obtained to enroll or allow the continued participation of a child enrolled in another study.
5. Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
6. Prematurity *37 weeks gestation
7. The child had changed medication within 4 weeks of the screening assessment (assessment should be deferred)
8. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessment (assessment should be deferred).
9. The child has had a severe exacerbation (requiring ER attendance or hospital admission and /or a course of high dose OCS for at least 3 days duration) within 4 weeks of the baseline assessment (assessment should be deferred).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The study will assess and integrate multiple parameters in terms of clinical,<br /><br>functional, cellular, molecular and patient reported outcomes for developing<br /><br>phenotype *handprints* of severe asthma and pre school wheeze. For each<br /><br>parameter a number of endpoints have been selected which will be used for the<br /><br>following goals:<br /><br>i. The characterization into phenotypic handprints of patients with severe<br /><br>asthma and pre school wheeze and the comparison of these characteristics with<br /><br>those with mild to moderate asthma and mild to moderate pre school wheeze.<br /><br>ii. To enable the linking of molecular targets for drug intervention with the<br /><br>pathophysiology of severe asthma and pre school wheeze<br /><br>iii. Based upon the integration of data collected from severe asthma and pre<br /><br>school wheeze patients, classifiers and predictors will be developed. This will<br /><br>form the basis of the initial phenotype handprint.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Nvt</p><br>