Monitoring Allergen Immunotherapy in Allergic Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-25

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Immunotherapy Rhinitis, Allergic Treatment Outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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allergen-specific immunotherapy (AIT)

Adults with birch pollen allergy, who are treated with allergen-specific immunotherapy (AIT)

A nasal fluid Basophil Activation Test (BAT)

Intervention Type OTHER

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

control

Adults with birch pollen allergy, who are treated with immunosuppressive medication

A nasal fluid Basophil Activation Test (BAT)

Intervention Type OTHER

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

Interventions

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A nasal fluid Basophil Activation Test (BAT)

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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