Biomarkers in ALlergic diseases and allergen Immunotherapy
- Conditions
- allergyimmunotherapy10001708
- Registration Number
- NL-OMON45948
- Lead Sponsor
- Franciscus Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
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.
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Predictive value of candidate biomarkers sIgE/tIgE and IgE-FAB on<br /><br>treatment-effect.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Correlate the biomarker sIgG4 with compliance.<br /><br>• Identify novel candidate biomarkers involved in the mechanisms of AIT.<br /><br>• Correlate novel candidate biomarkers with treatment response.<br /><br>• Compare local vs systemic biomarkers</p><br>