The aims of our study are:1. To use electronic nose measurements to discriminate between well-defined groups of children with different levels of asthma control. 2. To use electronic nose measurements to distinguish between different levels of FeNO…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- asthma control score
- VOC*s of breath prints in exhaled air by gas chromatography mass spectrometry
(GC-MS) and electronic nose (eNose).
- Fractional exhaled Nitric Oxide
- FEV1, PEF
Secondary outcome
not applicable
Background summary
The electronic nose seems to be able to discriminate between different
respiratory diseases. For asthma and COPD this discriminating capacity has
already been demonstrated. In children, the possibility of electronic nose
measurements has been less investigated. The electronic nose can be a usefull,
objective and non-invasive diagnostic tool in the respiratory clinic.
There is a group of patients with inconsistencies between their rapported
symptoms and the presence of airway inflammation. These patient are often
difficult to treat.
With this study we want to explore the possibility of the electronic nose to
discriminate between subgroups of children with different levels of asthma
control.
Hypothesis:
We hypothesize that analysis of exhaled breath by electronic nose measurements
can discriminate between subgroups of children with different levels of asthma
control.
Study objective
The aims of our study are:
1. To use electronic nose measurements to discriminate between well-defined
groups of children with different levels of asthma control.
2. To use electronic nose measurements to distinguish between different levels
of FeNO as a possible marker of airway inflammation.
3. To evaluate whether electronic nose measurements can capture subgroups of
children with asthma with a mismatch in between symptoms and inflammation.
Study design
This is a cross-sectional study. Data will be collected once per patient in a
period of 6 months, in the same occasion as their routine visit in the
outpatient clinics of the Academic Medical Centre and the VU University Medical
Centre. The research will take a maximum of 30 minutes per patient.
For logistical reasons part of the data (asthma control score, lung function
and FeNO and electronic nose values) to be used in this study will be extracted
from a database of a concomitant study running in the department (UBIOPRED METC
2011_039)). These patients will be asked to give separate permission for the
use of their anonymous data.
Asthma control will be evaluated by questionnaire. Afterwards exhaled breath,
FeNO and spirometry measurements will be performed. Spirometry will be measured
at last by hand-held spirometer (pikometer).
Study burden and risks
All procedures are non-invasive, safe and bring no discomfort to the
participants.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
General inclusion criteria:
- Males and females aged 6 to 17 years
- Parent / guardian must be able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to undertaking any study procedures.
- Assent should be obtained from all children in the study where appropriate.;For patients with asthma:
- Diagnosis of asthma given by specialists (data documented in patient records) according to the GINA guidelines.
Exclusion criteria
- Known underlying respiratory tract disease like congenital airway abnormalities, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia or bronchiectasis.
- Known systemic or inflammatory diseases.
- 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).
- The child has had a 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).
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 |
|---|---|
| Other | in aanvraag |
| CCMO | NL39477.018.12 |