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Monitoring Allergen Immunotherapy in Allergic Rhinitis

Monitoring Allergen Immunotherapy in Allergic Rhinitis; is Nasal Fluid the Way to Precision Medicine?

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05621356
Enrollment
25
Registered
2022-11-18
Start date
2022-10-25
Completion date
2023-03-31
Last updated
2022-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunotherapy, Rhinitis, Allergic, Treatment Outcome

Brief summary

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.

Detailed description

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.

Interventions

OTHERA nasal fluid Basophil Activation Test (BAT)

a BAT technique for monitoring the inhibitory effect of nasal fluid on basophil activation.

Sponsors

Wageningen University
CollaboratorOTHER
Rijnstate Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* IgE-sensitized birch pollen allergy * Start of Itulazax therapy or immunosuppressive therapy (nasal corticosteroid and/or antihistamine eye drops) * Signed informed consent

Exclusion criteria

* Other underlying chronic conditions (immunological (autoimmune or immunodeficiency), oncological) * Unstable uncontrolled asthma * Smoking

Design outcomes

Primary

MeasureTime frame
BAT outcome nasal fluid8 weeks
BAT outcome serum8 weeks

Secondary

MeasureTime frame
IgG4/IgA-associated inhibitory activity in nasal fluid8 weeks
IgG4/IgA-associated inhibitory activity in serum8 weeks

Countries

Netherlands

Contacts

Primary ContactJanneke Ruinemans-Koerts
j.ruinemans-koerts@rijnstate.nl0031 88 005 8888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026