BALI-study
- Conditions
- Allergic Rhinitis
- Registration Number
- NL-OMON28588
- Lead Sponsor
- Franciscus Gasthuis & VlietlandImperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 160
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.
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response to AIT will be considered as a binary outcome (yes/no) and will be monitored by:<br /><br>-Control of Allergic Rhinitis and Asthma Test (CARAT) (Appendix 1). <br /><br>-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);<br /><br>-Asthma Control Questionnaire (ACQ) (Appendix 2). The MCID of the ACQ is 0.5 points.<br /><br>-Frequency of asthma exacerbations.<br>
- Secondary Outcome Measures
Name Time Method We will explore the prevalence the use of allergen-specific IgG4 (sIgG4) as a biomarker for compliance.<br /><br /><br><br>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.<br /><br /><br><br>Biomarkers that can be explored may include:<br /><br>- Humoral biomarkers<br /><br>- Cytokine markers.<br>