Goals1. To investigate whether analysis of antibodies directed against active Beta1 and Beta 2-integrins (CD29/CD18) and FcγRII (CD32) of primed eosinophils allows the diagnosis of eosinophilic asthma as compared to analysis of sputum…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate whether analysis of antibodies directed against active β1/β2-
integrins (CD29/CD18) and FcγRII (CD32) of primed eosinophils allows the
diagnosis of eosinophilic asthma as compared to analysis of sputum
eosinophilia.
Secondary outcome
1. Measurement of antibodies against active β1/β2-integrins
and FcγRII
2. Measuring specific protein profiles in serum of asthma patients by
proteomics
3. FeNO measurement
Background summary
Asthma is a heterogeneous disease and can be classified by level of control,
disease severity and the inflammatory phenotype. However, these different
domains overlap and classification of patients according to these
characteristics has caused confusion in the literature. Concerning the
inflammatory phenotype international consensus is present regarding the
diagnostic power of induced sputum. This methodology is, however, difficult to
implement in general practice. Local inflammation is associated with a complex
combination of systemic pro- and anti-inflammatory signals that induce changes
in responsive leukocytes. These changes can be used as read-out for type and
degree of inflammatory disease.
Hypothesis: in asthma the analysis of type and degree of inflammation in
peripheral blood by changes in phenotypes of leukocytes is at least as reliable
as analysis of induced sputum. This will facilitate the diagnosis of
inflammatory phenotypes in asthma, as general application of induced sputum is
not feasible.
Study objective
Goals
1. To investigate whether analysis of antibodies directed against active
Beta1 and Beta 2-integrins (CD29/CD18) and FcγRII (CD32) of primed
eosinophils allows the diagnosis of eosinophilic asthma as compared to analysis
of sputum eosinophilia.
2. To evaluate the applicability of antibodies against active β1/β2-integrins
and FcγRII in symptomatic asthma patients as a test to diagnose eosinophilic
and neutrophilic asthma.
3. To determine specific protein profiles in serum of asthma patients by
proteomics for the development of a diagnostic test.
4. To evaluate the effectiveness of this new test in comparison with FeNO.
Study design
- Diagnostic study
- Cross-sectional cohort
Study burden and risks
The only SAE that could possibly occur is acute bronchoconstriction caused by
the hypertonic saline administrated during sputum induction. This could lead
acute hospitalisation if the patient does not respond well to the inhalation of
bronchodilating medication. This is however a very rare complication and only
one case report describing a fatal case has been published which was presumably
caused by sputum induction. If the guideline of the European Task Force for
sputum induction is followed, this risk is narrowed down to a marginal
proportion.
Heidelberglaan 100
3584CX Utrecht
NL
Heidelberglaan 100
3584CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
• Patients with adult asthma
• Age 18-75
• Visiting the outpatient clinic of the UMC and CMH Utrecht
• Suitable for sputum induction
Exclusion criteria
• smoking at present or in the last 12 months and/or a past history of more than 10 pack years
• antibiotic treatment for a respiratory tract infection <4 weeks prior to the study
• proven allergic bronchopulmonary aspergillosis.
• Other (chronic) Inflammatory disease(s) such as rheumatoid arthritis and inflammatory bowel disease
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 | NL37707.041.11 |