Identify phenotypes using clinical characteristics and non-invasive biomarkers that can guide treatment.
ID
Source
Brief title
Condition
- Allergic conditions
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in clinical characteristics and biomarker profiles between children
that remain difficult to treat upon standardized clinical care (based on
symptoms, exacerbations and lung function) and children that are controlled.
Secondary outcome
reduction in number of exacerbations
improvement in severe asthma questionnaire score
improvement in fatigue
unsupervised cluster analyses on the -omics data
Background summary
Pediatric asthma is a heterogeneous disease. With the emergence of novel
targeted-treatments for severe pediatric asthma (such as mepolizumab), it is
important to develop accurate and objective tests to discriminate between
different asthma phenotypes and guide treatment
Study objective
Identify phenotypes using clinical characteristics and non-invasive biomarkers
that can guide treatment.
Study design
Observational multicenter study. Children will be treated according to a
standardized clinical care protocol. Addition study measurements consist of:
questionnaires (to obtain patient-reported outcomes, such as fatigue and
quality of life), exhaled breath measurements (in case patients report to the
hospital) and nasal brushes (during inclusion). Patients are followed for 6
months.
Study burden and risks
The burden of the children and parents is low to moderate. Collection of
biosamples (exhaled breath, nasal brushes, DNA isolation from saliva) will be
combined with regular clinical care visits and have a limited burden. In the
future, the results of this study could lead to improved treatment for
paediatric patients.
Meibergdreef 9
Amsterdam-Zuidoost 1105AZ
NL
Meibergdreef 9
Amsterdam-Zuidoost 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Between 6-17 years of age
- Doctor*s diagnosis of asthma
- Treated on asthma GINA treatment step 3 or higher
- Signed informed consent from parents (guardians) and children (when
applicable)
- Dutch speaking
Exclusion criteria
Serious lung disease other than asthma (cystic fibrosis, primary ciliary
dyskinesia, congenital lung disorders, severe immune disorders).
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 | NL67105.018.18 |