We postulate that exhaled molecular profiling obtained from *breathprints* by electronic nose:1. Will discriminate eosinophilic asthma from non-eosinophilic asthma2. Is associated with individual biomarkers and specific proteomic profiles in induced…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
eNose breathprints of eosinophilic and non-eosinophilic asthmatic subjects.
Secondary outcome
* Specific molecular components that are associated with eosinophilic and
non-eosinophilic asthma as determined by gas-chromatography and
mass-spectrometry
* Individual biomarkers and proteomic profiles in sputum, blood, urine, nasal
lavage and nasal biopsies predictive for eosinophilic and non-eosinophilic
asthma
Background summary
Based on the presence of eosinophilia in sputum, asthma can be divided into
eosinophilic and non-eosinophilic types. There is recent evidence from clinical
follow-up studies that inflammatory (sub)phenotyping of patients can help to
optimize therapy and disease outcome. Sputum induction by hypertonic saline is
generally considered a reliable non-invasive method to assess and monitor
airways inflammation. However, the application of sputum analysis is somewhat
limited by the requirement of lab facilities and the not-directly available
results, so adequate surrogate markers of airway inflammation in asthma are
required. Electronic nose (eNose) technology combines the non-invasiveness of
measuring exhaled breath with real-time analysis of the complete spectrum of
volatiles. We recently showed that the electronic nose is able to discriminate
exhaled breath from well-characterized subjects with asthma, COPD and controls.
This indicates that an electronic nose offers the opportunity to simplify and
improve the monitoring of patients with asthma.
Study objective
We postulate that exhaled molecular profiling obtained from *breathprints* by
electronic nose:
1. Will discriminate eosinophilic asthma from non-eosinophilic asthma
2. Is associated with individual biomarkers and specific proteomic profiles in
induced sputum, blood, urine, nasal lavage and nasal biopsy specimen
Study design
Cross-sectional study with two visits. Visit 1: screening of clinical
characteristics. Visit 2: Collecting measurements by sputum induction,
collecting exhaled air, blood withdrawal, nasal lavage and up to 4 nasal
biopsies, and collecting urine.
Study burden and risks
For this study there are no major risks involved and the eventual occurrence of
a discomfort for the patient will be minimized by the involvement of qualified
professionals in the procedures. The only invasive methods in this study
include blood withdrawal and 4 nasal biopsies. The patients themselves will not
benefit directly from this investigation. However, the group of asthmatic
patients may benefit from this study in the future. Gaining further knowledge
on the subphenotypes of asthma will aid future discovery of novel diagnostic
procedures (like eNose and GC-MS) and therapeutic targets. As such, we consider
the balance between risks and discomfort for the patients (low) and the
possible benefit for these patient groups in the future (potentially high)
acceptable.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Age >18 years
* Clinical presentation of asthma
* Airway hyperresponsiveness, indicated by a positive methacholine challenge with PC20 * 8 mg/ml OR
* reversibility in FEV1 of * 12% predicted
* Requiring inhaled corticosteroids at high doses (* 500 ug ICS fluticasone or equivalent)
* Non-smoking or stopped smoking more than 12 months ago and 10 pack years or less
* No condition or treatment which may increase the risk of bleeding
* No other clinically significant abnormality on history and clinical examination
* Able to give written and dated informed consent prior to any study-specific procedures
- sputum eosinophils > 3% * eosinophilic asthma
- sputum eosinophils < 1% * non-eosinophilic asthma
Exclusion criteria
* Change in the dose of ICS in 4 weeks prior to screening
* A course of oral corticosteroids, antibiotics or a respiratory infection within 4 weeks prior to the study
* Use of anti-leukotrienes, chromoglycates, anti-cholinergics within 4 weeks prior to the study
* 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 | NL30897.018.09 |