Monitoring Allergen Immunotherapy in Allergic Rhinitis

Immunotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621356
• Other study ID #: 2021-1924
• Secondary ID: NL78278.091.21
• Status: Recruiting
• Start date: October 25, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2022
• Source: Rijnstate Hospital
• Contact: Janneke Ruinemans-Koerts
• Phone: 0031 88 005 8888
• Email: j.ruinemans-koerts[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 31, 2023
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunotherapy
• Rhinitis
• Rhinitis, Allergic
• Treatment Outcome

Intervention

Other:
• A nasal fluid Basophil Activation Test (BAT)
a BAT technique for monitoring the inhibitory effect of nasal fluid on basophil activation.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BAT outcome nasal fluid		8 weeks
Primary	BAT outcome nasal fluid		16 weeks
Primary	BAT outcome serum		8 weeks
Primary	BAT outcome serum		16 weeks
Secondary	IgG4/IgA-associated inhibitory activity in nasal fluid		8 weeks
Secondary	IgG4/IgA-associated inhibitory activity in nasal fluid		16 weeks
Secondary	IgG4/IgA-associated inhibitory activity in serum		8 weeks
Secondary	IgG4/IgA-associated inhibitory activity in serum		16 weeks