Monitoring Allergen Immunotherapy in Allergic Rhinitis

Recruiting

• Conditions: Immunotherapy; Treatment Outcome; Rhinitis, Allergic
• Interventions: Other: A nasal fluid Basophil Activation Test (BAT)

• Registration Number: NCT05621356
• Lead Sponsor: Rijnstate Hospital

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.

Study Timeline

• Study Start: 2022-10-25
• Status Verified: 2022-11
• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Study First Posted: 2022-11-18
• Last Update Posted: 2022-11-18
• Primary Completion: 2022-12-23
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
allergen-specific immunotherapy (AIT)	A nasal fluid Basophil Activation Test (BAT)	Adults with birch pollen allergy, who are treated with allergen-specific immunotherapy (AIT)
control	A nasal fluid Basophil Activation Test (BAT)	Adults with birch pollen allergy, who are treated with immunosuppressive medication

Primary Outcome Measures

Name	Time	Method
BAT outcome serum	16 weeks
BAT outcome nasal fluid	16 weeks

Secondary Outcome Measures

Name	Time	Method
IgG4/IgA-associated inhibitory activity in serum	16 weeks
IgG4/IgA-associated inhibitory activity in nasal fluid	16 weeks

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands