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Recruiting NCT06421415

Long Term Effect of AIT in Children

Observational Allergy in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Allergen Immunotherapy Extract.
Who it may be relevant to
Registry conditions: Allergy in Children. Basic parameters: 4 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The present study will investigate the long term effect of allergen immunotherapy in a real-life study in children with allergy undergoing subcutaneous or sublingual immunotherapy with grass pollen, birch, house dust mites or venom.

Detailed description

The study will include children aged 5- 18 years who are treated with immunotherapy at Hans Christian Andersen Children' Hospital, Odense University Hospital.

Informed consent to be registered in a database and to receive a questionnaire 5 and 10 years after end of treatment are obtained before start of immunotherapy.

Base line data include information from the patient record: symptoms, medication, blood test and skin prick test results. During treatment effect, medication use, lung function and adverse events are monitored systematically once a year.

The questionnaires 5 and 10 years after end of treatment will focus on allergy symptoms, use of medication and asthma symptoms.

Interventions

  • Drug Allergen Immunotherapy Extract
    Patients will be treated as usual. The study is an observation of the long term effect of the treatment

Primary outcome measures

  • Effect of immunotherapy 5 years after end of treatment [Time frame: 5 years]
Secondary outcome measures (1)
  • Effect of immunotherapy 10 years after end of treatment [Time frame: 10 years]

Eligibility criteria

Inclusion Criteria: treated with allergen immunotherapy at HCA Children'sHospital, Odense University Hospital -

Exclusion Criteria: received less than 12 months of treatment with allergen immunotherapy

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 2 centers
  • Hans Christian Andersen Children's Hospital — Odense
  • Hans Christian Andersen Children's Hospital — Odense

Identifiers

NCT: NCT06421415 · HCA-AIT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗