1. Optimize breath collection settings for optimal use in children.2. Evaluate the use of breath biomarkers for the prediction of therapeutic response in asthmatic children.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in exhaled biomarker profile, between children responding to
treatment and children not responding to treatment.
Secondary outcome
Target biomarker concentrations of different breath fractions of the same
patient will be compared and aggregated at a group level. Assessed parameters
will include the reproducibility and the breath fraction that carries the
highest chemical information content, highest level of target biomarkers and
allows the shortest collection time. Taking these various factors into account
an optimal sampling strategy will be selected. This strategy will be used to
study the secondary and main study aim.
Background summary
Asthma is the most common chronic respiratory disease in childhood. A subset of
asthma patients does not reach adequate levels of control despite being on high
dose treatment. These patients are responsible for a disproportionate fraction
of 1) reduced school attendance and 2) asthma related deaths 3) the health
costs pressurizing healthcare infrastructure. Therefore there is an urgent need
to develop non-invasive diagnostic tools that match the right patient to the
right treatment from the outset of their treatment. Current tests for
stratification of asthma patients are not optimal. This has prevented asthma
stratification from being widely implemented resulting in over- and under
treatment of patients.
Previous research has revealed the existence of exhaled biomarkers (VOCs) that
differentiate between various inflammatory processes in the airway. VOC*s are
easily accessible candidate biomarkers for therapy stratification and response
monitoring and have been shown to be applicable in asthma patient
stratification.
In order to bring VOC based stratification to the clinic, standardization of
sample collection and the analysis of the VOCs is required. We recently
co-developed the ReCIVA breath sampler as part of Breathe Free Open Source
Breath sampler Consortium. This device enables highly standardized, quick and
easy breath collection and allows targeted selection of breath fractions
allowing a focus on those fractions carrying the highest concentration of
target biomarkers (www.breathe-free.org).
Study objective
1. Optimize breath collection settings for optimal use in children.
2. Evaluate the use of breath biomarkers for the prediction of therapeutic
response in asthmatic children.
Study design
This study is designed as a prospective cohort study integrated into clinical
practice (see protocol, section 3 Methods).
Study burden and risks
Sampling of breath is extremely non-invasive. The method does not impose any
resistance to inspiration or expiration. Previously this device has been
validated and in addition evaluated for patient discomfort in a population of
5-7 year-old children. We found that children did not experience any discomfort
while breathing in this breath sampling device. No extra visits/procedures
outside breath collection will be part of this study.
The STRATA study is a low risk study that does not interfere with normal
clinical treatment pathways. According to the *CRU risicoinschatting* this
study has a risk of negligible risk.
We will perform clinical data monitoring, technical monitoring and monitoring
of patient acceptance.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Asthma diagnosis: established clinician diagnosis of asthma according to GINA guidelines
Treatment: patients receiving GINA step 3,4 or 5 treatment
Age: *6 - < 18 years
Exclusion criteria
Established other pulmonary disease
Recent IMP study within 5.5 half lives of the study drug to the date of last drug administration.
Not being able to perform lung function measurements due to neurologic disease or developmental delay
Design
Recruitment
Medical products/devices used
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 | NL59286.018.16 |