An observational study in Immunotherapy, Rhinitis, Allergic and Treatment Outcome, sponsored by Rijnstate Hospital. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.
Sponsored by Rijnstate Hospital · Observational
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.
This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood.
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 reflect therapy effect (inhibition of an IgE-mediated allergic reaction) as the nose is the main target organ for AIT in allergic rhinitis.
This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood. Nasal fluid and blood samples are collected at baseline 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.
15 adults with birch pollen allergy, who are treated with AIT (Itulazax birch pollen tablet) and 10 adults with birch pollen allergy, who are treated with immunosuppressive medication (control group) will be included in the study.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's planned enrollment of 25 is below the median of 141 across 172 observational studies indexed under Rhinitis.
Browse Rhinitis studies →Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Birch pollen allergic patients who are treated with Itulazax (birch pollen SLIT-tablet) and birch pollen allergic patients who are treated with immunosuppressive medication (control group).
Exclusion Criteria:
Adults with birch pollen allergy, who are treated with allergen-specific immunotherapy (AIT)
Other: A nasal fluid Basophil Activation Test (BAT)
Adults with birch pollen allergy, who are treated with immunosuppressive medication
Other: A nasal fluid Basophil Activation Test (BAT)
a BAT technique for monitoring the inhibitory effect of nasal fluid on basophil activation.
BAT outcome nasal fluid
Time frame: 8 weeks
BAT outcome nasal fluid
Time frame: 16 weeks
BAT outcome serum
Time frame: 8 weeks
BAT outcome serum
Time frame: 16 weeks
IgG4/IgA-associated inhibitory activity in nasal fluid
Time frame: 8 weeks
IgG4/IgA-associated inhibitory activity in nasal fluid
Time frame: 16 weeks
IgG4/IgA-associated inhibitory activity in serum
Time frame: 8 weeks
IgG4/IgA-associated inhibitory activity in serum
Time frame: 16 weeks
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rijnstate Hospital