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Monitoring allergen immunotherapy in allergic rhinitis; is nasal fluid the way to precision medicine?

Recruiting
Conditions
hay fever
rhinitis
10001708
Registration Number
NL-OMON52036
Lead Sponsor
Rijnstate Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
25
Inclusion Criteria

a. Age >= 18 years
b. IgE-sensitized birch pollen allergic based on:
- sIgE tree pollen > 10 kU/L
- seasonal related allergic rhinitis
c. Start of Itulazax therapy or standard therapy (nasal corticosteroid and/or
antihistamine eye drops)
d. Signed informed consent.

Exclusion Criteria

a. Age < 18 years
b. Other underlying chronic conditions (immunological (autoimmune or
immunodeficiency), oncological)
c. Unstable uncontrolled asthma
d. Smoking.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Comparison of BAT outcomes (degree of inhibition) with nasal fluid BAT and<br /><br>serum BAT of treated and control patients at baseline and during AIT at 8 and<br /><br>16 weeks.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Correlation between the degree of inhibition in the BAT with the degree of<br />increase of IgG4/IgA-associated inhibitory activity in nasal fluid and serum on<br />IgE-FAB to B-cells.</p>
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