Allergic Rhinitis
Conditions
Interventions
No intervention. We collect blood through venapuncture and nasal fluid through nasal swabs.
Sponsors
Franciscus Gasthuis & Vlietland
Imperial College London
Eligibility
Inclusion criteria
Inclusion criteria: - 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. - Minimum of 16 years of age and a confirmed clinical diagnosis of allergic rhinitis. - Clinical indication for AIT (according to EAACI guidelines). Signed and dated informed consent (IC) form by a legally competent participant.
Exclusion criteria
Exclusion criteria: History of chronic autoimmune disease (aside from asthma, atopic dermatitis or allergic rhinitis) which may interfere with results. Use of an antihistamines or decongestant therapy 7 days prior to screening visit. Prior exposure to any monoclonal antibody treatment within the past 12 months. Contraindication to sublingual or subcutaneous AIT. Current immunosuppressive treatment. Previous immunotherapy with grass pollen, tree pollen or house dust mite extract.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response to AIT will be considered as a binary outcome (yes/no) and will be monitored by: -Control of Allergic Rhinitis and Asthma Test (CARAT) (Appendix 1). -Requirement of medication related rhinitis and/or asthma treatment. This includes oral first- and second-generation anti-histamine, nasal corticosteroid, bronchodilators, inhaled corticosteroid (ICS), and ICS + long-acting ¦Â2-agonist (LABA); -Asthma Control Questionnaire (ACQ) (Appendix 2). The MCID of the ACQ is 0.5 points. -Frequency of asthma exacerbations. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will explore the prevalence the use of allergen-specific IgG4 (sIgG4) as a biomarker for compliance. Apart from the suggested candidate biomarkers the project will focus on novel candidate biomarkers both for clinical follow up as well as unravelling the mechanism of AIT. For this exploratory research novel techniques, such as for example genomics and proteomics, will be used to explore for new candidate markers. Biomarkers that can be explored may include: - Humoral biomarkers - Cytokine markers. | — |
Outcome results
None listed