1. To identify breathprints of volatile organic compounds which are associated with loss of asthma control (deterioration in symptoms and lung function) after interruption of inhaled steroid therapy.2. To examine the critical VOCs of these…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in eNose breathprint at loss of control compared to stable condition,
after completion of 8 weeks steroid withdrawal phase.
Secondary outcome
1. Individual biomarkers in sputum, blood ann exhaled breath condensate (EBC)
that are associated with asthma control and with electronic nose ann GC-MS
breathprints.
2. Hemostatic activity.
Background summary
In asthma, symptoms and lung function are only moderately associated with a
change in airways inflammation, as in a period of loss of control or
exacerbation. Therefore, there is a need for biomarkers that reflect
inflammation more directly and that are easy to obtain. Direct on-line
assessment of exhaled air volatile organic compounds (VOCs) may avoid the need
of special tests in expert centres and will particularly be suitable in primary
care and for the so-called poor-perceivers of exacerbation symptoms.
The current study will assess the ability of exhaled breath molecular profiling
using an electronic nose and gas chromatography and mass spectrometry to
discriminate breath molecular profiles (breathprints) from asthma patients
during controlled and uncontrolled periods. For this purpose, an exacerbation
will be induced by interruption of inhaled corticosteroids.
Study objective
1. To identify breathprints of volatile organic compounds which are associated
with loss of asthma control (deterioration in symptoms and lung function) after
interruption of inhaled steroid therapy.
2. To examine the critical VOCs of these breathprints in exhaled air by gas
chromatography and mass spectrometry (GC-MS).
3. To identify individual biomarkers in sputum, blood and EBC that are
associated with asthma control and electronic nose and GC-MS breathprints.
4. To examine the effect of loss of asthma control by interruption of inhaled
steroids on haemostatic activity.
5. To examine whether there is an association between markers of coagulation,
inflammation and exhaled molecular profiles assessed by electronic nose and
GC-MS.
Study design
14 weeks prospective follow-up study. Reduction of clinical control and
re-establishment of control will be obtained by cessation and restoration of
inhaled steroids.
Intervention
Breath measurements by electronic nose platform and GC-MS and sputum and blood
biomarkers will be monitored at baseline, and during withdrawal and restoration
of inhaled steroids.
Study burden and risks
Patients will interrupt regular inhaled corticosteroids. This will cause a
transient loss of asthma control. The model that is used in this study proved
to be safe.
Direct benefits for the patients lie within the increased awareness they will
get of their asthma symptoms and symptom fluctuations, which will increase the
self-management of the disease.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Age: at least 18 years.
- Mild to moderately severe persistent asthma according to the GINA criteria.
- Using at least a daily dose of inhaled corticosteroids (* 500 ug ICS fluticasone or equivalent).
- Controlled or partly controlled asthma according to the criteria by GINA.
- Exacerbations: one or more in the past 2 years.
- Non-smoking or stopped smoking more than 12 months ago and a total maximum of 5 pack years.
- No other clinically significant abnormality on history and clinical examination.
- Able to give written and dated informed consent prior to any study-specific procedures.
Exclusion criteria
- Change in the dose of inhaled corticosteroids within 4 weeks prior to screening.
- A course of oral corticosteroids, antibiotics or a respiratory infection within 4 weeks prior to the study.
- Use of ipratropium, anti-IgE or oral corticosteroids.
- Pregnancy.
- Concomitant disease or condition which could interfere with the conduct of the study, or which treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study.
- Unwillingness or inability to comply with the study protocol for any other reason.
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 | NL36067.018.11 |