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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05621356
Other study ID # 2021-1924
Secondary ID NL78278.091.21
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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