1. To identify -omics biomarkers and possible relationships/interactions between them that allow the classification the different phenotype of non-response to standard ICS asthma therapy.2. To construct computational algorithms that effectively…
ID
Source
Brief title
Condition
- Allergic conditions
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in biomarker profiles (breathomics, microbiomics, metabolomics,
epigenomics and [pharmaco]genomics), between children responding to treatment
and children not responding to treatment.
Secondary outcome
We will compare the biomarkers profiles of cases during an exacerbation and
controls, as well as the profiles within subjects (during and after
exacerbation). Construction of the -omics algorithm to predict ICS response
Background summary
Asthma is the most common chronic disease in children and affects ~1 out of 10
children. Children respond reasonably well to standard therapy with inhaled
corticosteroids (ICS), however, there is large inter-individual variability,
and a substantial proportion of children reaches only partly control of the
disease (40-70%). Moreover, approximately 10-15% of patients will suffer from
severe symptoms despite regular use of ICS. It is important to characterize
biomarkers that identify children at risk for uncontrolled asthma in an early
stage so they can be referred to specialized care. In this project we will
apply an innovative systems medicine approach in saliva, blood, urine, feces,
and exhaled breath samples in well-phenotyped well-controlled asthmatic
children and asthmatic children that do not respond to standard therapy with
ICS (non-responders).
Study objective
1. To identify -omics biomarkers and possible relationships/interactions
between them that allow the classification the different phenotype of
non-response to standard ICS asthma therapy.
2. To construct computational algorithms that effectively predict phenotype of
ICS response by using a set of system-wide biomarkers and their interactions
with environmental and clinical factors.
Study design
Observational study. Data analysis will be performed within an international
research consortium.
Study burden and risks
The burden of the children and parents is low. There is one invasive
measurement: a venapunction (20mL). EMLA cream (a topical anesthetic) will be
used to decrease the sensation of pain associated with the venapunction. The
venapuction has a small risk of haemorrhage. This will be reduced by the fact
that we will work with trained researchers or research nurses. Furthermore,
there are no risks for the participation in the study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
General:
- Between 6-18 years of age
- Doctor diagnosis of asthma;In addition to the general criteria, a case with uncontrolled asthma (case group A) should meet:
- Asthma treatment Global INitiative of Asthma (GINA) step 3 or higher
- * 1of the following criteria (based on the guideline *Childhood Asthma* of the section paediatric pulmonology of the Dutch Society of Pediatricians, 2007):
- Frequent exacerbations requiring OCS use (*1 in the past year) and/or
- Severe exacerbations requiring hospitalization or ER visits in the past year and/or
- ACQ/ACT scores indicating uncontrolled asthma ;In addition to the general criteria, a case with an acute exacerbation (case group B) should meet:
- Asthma treatment Global INitiative of Asthma (GINA) step 2 or higher
- Current severe asthma exacerbation requiring hospitalization ;In addition to the general inclusion criteria, a control should meet the following criteria:
- Asthma treatment Global INitiative of Asthma (GINA) step 3 or higher
- Lack of severe exacerbations requiring OCS use or hospitalizations or ER visits in the past year
Exclusion criteria
- Recent use of a course of antibiotics (< 1 month). This will affect the microbiome analyses.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55788.041.15 |