We aim to identify the predictive value of the candidate biomarkers suggested by the EAACI taskforce for response to AIT. Additionally, we aim to explore novel candidate biomarkers both for clinical follow up as well as contribute to unravelling the…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Predictive value of candidate biomarkers sIgE/tIgE and IgE-FAB on
treatment-effect.
Secondary outcome
• Correlate the biomarker sIgG4 with compliance.
• Identify novel candidate biomarkers involved in the mechanisms of AIT.
• Correlate novel candidate biomarkers with treatment response.
• Compare local vs systemic biomarkers
Background summary
Allergen Immunotherapy (AIT) has been proven to have disease-modifying
properties and long-term clinical benefit after cessation in patients with or
without allergic asthma. However, some patients do not respond optimally. To
date there is no consensus on candidate biomarkers that are predictive of the
clinical response to AIT. In addition, a recent position paper by an EAACI
taskforce advises to start research initiatives in order to correlate candidate
biomarkers to responders and non-responders.
Study objective
We aim to identify the predictive value of the candidate biomarkers suggested
by the EAACI taskforce for response to AIT. Additionally, we aim to explore
novel candidate biomarkers both for clinical follow up as well as contribute to
unravelling the mechanism of AIT.
Study design
This research project is twofold. Firstly: an observational, prospective cohort
design to test the predictive value of the suggested biomarkers. Secondly: a
case-control design to explore novel candidate biomarkers and obtain more
insight in the mechanism involved in AIT.
Study burden and risks
Patients will be asked to donate 200ml of full blood per visit (7 visits in
total). This can cause a bruise or hematoma at the site of the venepuncture
which is considered a low risk event. Feeling light-headedness which in some
cases can lead to syncope is also a possibility. Furthermore, patients will be
asked to fill out two questionnaires per visit (CARAT and ACQ), requiring ten
minutes total per visit for both questionnaires.
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
1. Positive Skin Prick Test (SPT) response of >= 8 mm wheal diameter and/or serum allergen-specific IgE levels higher than 0.70 kU/L to grass pollen, tree pollen and/or house dust mite (HDM) extract.
2. Minimum of 18 years of age and a confirmed clinical diagnosis of allergic rhinitis.
3. Clinical indication for AIT.
4. Signed and dated informed consent (IC) form by a legally competent participant.
Exclusion criteria
1. History of chronic autoimmune disease (aside from asthma, atopic dermatitis or allergic rhinitis) which may interfere with results.
2. Use of an antihistamines or decongestant therapy 7 days prior to screening visit.
3. Prior exposure to any monoclonal antibody treatment within the past 12 months.
4. Contraindication to sublingual or subcutaneous AIT.
5. Current immunosuppressive treatment.
6. Current pregnancy or breastfeeding, active pregnancy wish.
7. Previous immunotherapy with grass pollen, tree pollen or house dust mite extract.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67580.100.18 |
| OMON | NL-OMON28588 |