Monitoring Allergen Immunotherapy in Allergic Rhinitis
2 other identifiers
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2022
CompletedFirst Submitted
Initial submission to the registry
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedNovember 18, 2022
November 1, 2022
2 months
November 10, 2022
November 10, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
BAT outcome nasal fluid
8 weeks
BAT outcome nasal fluid
16 weeks
BAT outcome serum
8 weeks
BAT outcome serum
16 weeks
Secondary Outcomes (4)
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
Study Arms (2)
allergen-specific immunotherapy (AIT)
Adults with birch pollen allergy, who are treated with allergen-specific immunotherapy (AIT)
control
Adults with birch pollen allergy, who are treated with immunosuppressive medication
Interventions
a BAT technique for monitoring the inhibitory effect of nasal fluid on basophil activation.
Eligibility Criteria
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).
You may qualify if:
- IgE-sensitized birch pollen allergy
- Start of Itulazax therapy or immunosuppressive therapy (nasal corticosteroid and/or antihistamine eye drops)
- Signed informed consent
You may not qualify if:
- Other underlying chronic conditions (immunological (autoimmune or immunodeficiency), oncological)
- Unstable uncontrolled asthma
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rijnstate Hospitallead
- Wageningen Universitycollaborator
Study Sites (1)
Rijnstate Hospital
Arnhem, 6815 AD, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2022
First Posted
November 18, 2022
Study Start
October 25, 2022
Primary Completion
December 23, 2022
Study Completion
March 31, 2023
Last Updated
November 18, 2022
Record last verified: 2022-11