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Exploring the effectiveness of Itulazax on birch-related food allergy in adults treated with Itulazax for birch pollen allergy

Exploring the effectiveness of Itulazax on birch-related food allergy in adults treated with Itulazax for birch pollen allergy - ItulaFAR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53964
Enrollment
45
Registered
2022-11-11
Start date
2023-03-13
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pollen-food-syndrome treepollen related food allergy

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Adults (18 years or older) with allergic rhinitis for treepollen who will start with Itulazax (SLIT treepollen). - Pollen-food synrome for at least one of the cross-related allergens with birchpollen (bet v1) and sensibilisation in skinpricktesting or ImmunoCAP. - The abbility to sign informed consent.

Exclusion criteria

Exclusion criteria: - Patients with allergic rhinitis without treepollensensibilisation. - Patients with allergic rhinitis, but without food allergy. - Patients with a contraindication for Itulazax (due to the SMPC) - Patients younger 65 years - Patients with chronic spontaneous urticaria and/or chronic spontaneous angiooedema. - Patients who do not speak the Dutch language. - Patients who do not want or are able to sign the informed consent - Patient with previous treatment of subcutaneous immunotherapy birchpollen in the last 3 years.

Design outcomes

Primary

MeasureTime frame
Does the use of Itulazax 12 SQ-Bet lyophilisate (a sublingual tree pollen immunotherapy) in adults with allergic rhinitis and paraberk syndrome affect the pollen-food-syndrome? Primary outcome measure In patients treated for allergic rhinitis with Itulazax who also have pollen-food-syndrome, what is the effect on food allergy-related quality of life at 1 and 3 years relative to baseline as measured by the Food Allergy Quality of Life Questionnaire - Adult Form ( FAQLQ-AF).

Secondary

MeasureTime frame
o In patients treated with Itulazax for allergic rhinitis who also have pollen-food-syndrome, what is the effect on: - The threshold of food allergy - Severity of food allergy - Time that the complaints persist - Height of specific IgE - Size of skin reaction after skin test - Possibility of ingestion of fresh/raw products in the context of pollen-food-syndrome that previously gave complaints - The basophil activation test (BAT) in hazelnut-allergic patients o Which factors (including demographic factors, skin test, sIgE in blood, severity of food allergy, type of food) are related to a good effect of Itulazax on pollen-food-syndrome? o Does the patient's expectation of the effect of Itulazax on food allergy symptoms influence the primary and secondary outcome measures?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)