The study will be divided into two projects: Reproducibility study: To assess reproducibility of analysis of EBC by means of Orbitrap MS, in asthmatic children, with and without atopy.Correlation study: To correlate the results of Orbitrap MS…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reproducibility study: In this study first the reproducibility of EBC profiles
will be assessed. Second, we expect to find different patterns in asthmatic and
healthy subjects and in atopic versus nonatopic subjects.
Correlation study: Correlation between EBC and BALF is the primary study
parameter.
Secondary outcome
n.v.t.
Background summary
Diagnosing asthma is not simple. Symptoms are non-specific, making it difficult
to distinguish asthma from other respiratory diseases. Diagnosing asthma in
preschool children is even more difficult because lung function tests can not
be performed.
Therefore there is a need for a noninvasive, validated method to phenotype the
airway pathology in early childhood wheezing, to rationalize and to improve
treatment and avoid unnecessary treatment.
A new method for diagnosing airway disease is collection and analysis of
exhaled breath condensate (EBC). EBC analysis provides a non-invasive insight
in biochemical and inflammatory activity in pulmonary diseases.
With a new analysing method, Orbitrap MS, a new proteomics technology with very
high resolution to derive information on biomolecules, we expect to detect the
low concentrations of biomarkers in EBC more easily.
Study objective
The study will be divided into two projects:
Reproducibility study: To assess reproducibility of analysis of EBC by means of
Orbitrap MS, in asthmatic children, with and without atopy.
Correlation study: To correlate the results of Orbitrap MS analysis of EBC with
bronchoalveolar lavage fluid (BALF) in children.
Study design
This project is a pilot study on reproducibility of EBC analysis and
correlation between EBC and BALF by Orbitrap MS. It is a prospective
cross-sectional study on asthmatic and healthy children, non-interventional and
non-therapeutical.
Study burden and risks
Reproducibility study: Patients and parents will be asked to visit the
outpatient clinic for three times. During the first visit EBC will be
collected two times; FENO-measurement and a flow volume curve will be done.
During the second and third visit, EBC will be collected only once. Patients
will be asked to keep a diary for a week during the study. No risks are
associated with participation.
Correlation study: Bronchoscopy and bronchoalveolar lavage are performed in
subjects who have an indication for bronchoscopy for clinical reasons as
indicated by the pediatric pulmonologist. The extra burden is that children
will have to perform EBC collection once during a routine outpatient clinic
visit.
Dr. Molewaterplein 60
3015 GJ Rotterdam
Nederland
Dr. Molewaterplein 60
3015 GJ Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Reproducibility study:
- Patients between 4 and 18 years
- Able to perform EBC collection/ FENO analysis
- Atopic patients: RAST class 2 or higher for at least one aeroallergen ever
- Healthy controls between 4-18 years with a negative ISAAC questionnaire for asthma, eczema and rhinitis, and normal FENO and flow-volume curve.
- Written informed consent;Correlation study:
- Patients under the age of 18
- Indication for bronchoscopy for clinical reasons as indicated by the pediatric pulmonologist
- Written informed consent
Exclusion criteria
Reproducibility and correlation study:
- Extrapulmonary diseases
- Mental retardation
- Active smoking
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 | NL17198.078.07 |