Monitoring Allergen Immunotherapy in Allergic Rhinitis

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Janneke Ruinemans-Koerts; Phone Number: 0031 88 005 8888; Email: j.ruinemans-koerts@rijnstate.nl

Study Locations

• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Recruiting
    • Rijnstate Hospital
    • Contact: Janneke Ruinemans-Koerts; Phone Number: 0031 88 005 8888

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
allergen-specific immunotherapy (AIT); Adults with birch pollen allergy, who are treated with allergen-specific immunotherapy (AIT)	Other: A nasal fluid Basophil Activation Test (BAT); 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	Other: A nasal fluid Basophil Activation Test (BAT); a BAT technique for monitoring the inhibitory effect of nasal fluid on basophil activation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BAT outcome nasal fluid	8 weeks
BAT outcome nasal fluid	16 weeks
BAT outcome serum	8 weeks
BAT outcome serum	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
IgG4/IgA-associated inhibitory activity in nasal fluid	8 weeks
IgG4/IgA-associated inhibitory activity in nasal fluid	16 weeks
IgG4/IgA-associated inhibitory activity in serum	8 weeks
IgG4/IgA-associated inhibitory activity in serum	16 weeks

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: Wageningen University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Anticipated): December 23, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: 2021-1924; NL78278.091.21 (Other Identifier: CCMO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No