This project will investigate whether a BAT with nasal fluid is suitable for predicting therapy effect at an early stage.
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of BAT outcomes (degree of inhibition) with nasal fluid BAT and
serum BAT of treated and control patients at baseline and during AIT at 8 and
16 weeks.
Secondary outcome
Correlation between the degree of inhibition in the BAT with the degree of
increase of IgG4/IgA-associated inhibitory activity in nasal fluid and serum on
IgE-FAB to B-cells.
Background summary
Allergic rhinitis (hay fever) can be treated successfully with
allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive
and prolonged treatment is not suitable for everyone and therefore it is
important to predict who will benefit from this therapy early after the start
of treatment. Biomarkers, like Basophil Activation Test (BAT) and
IgE-facilitated allergen binding (FAB), using nasal fluid instead of blood,
probably better reflects therapy effect (inhibition of an IgE-mediated allergic
reaction) as the nose is the main target organ for AIT in allergic rhinitis.
Study objective
This project will investigate whether a BAT with nasal fluid is suitable for
predicting therapy effect at an early stage.
Study design
A pilot observational study. Nasal fluid and blood samples are collected at
baseline (before start AIT) and after 8 and 16 weeks of treatment. A nasal
fluid inhibition BAT is developed and validated by comparison with a BAT using
serum and an IgE-FAB assay.
Study burden and risks
Nasal fluid and blood sampling will take place according to standard
procedures. Risks of participation include the regular risks involved in the
sampling procedures; i.e. irritation and a dry feeling in the nose (collection
of nasal fluid) and pain and bruises (collection blood samples).
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
a. Age >= 18 years
b. IgE-sensitized birch pollen allergic based on:
- sIgE tree pollen > 10 kU/L
- seasonal related allergic rhinitis
c. Start of Itulazax therapy or standard therapy (nasal corticosteroid and/or
antihistamine eye drops)
d. Signed informed consent.
Exclusion criteria
a. Age < 18 years
b. Other underlying chronic conditions (immunological (autoimmune or
immunodeficiency), oncological)
c. Unstable uncontrolled asthma
d. 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 | NL78278.091.21 |