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NCT Number: NCT06421415

Long Term Effect of AIT in Children

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.

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Key information

Conditions

Allergy in Children

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hans Christian Andersen Children's Hospital, Odense, Odense C, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Allergen Immunotherapy Extract

Drug

Patients will be treated as usual. The study is an observation of the long term effect of the treatment

Primary outcomes

  1. Effect of immunotherapy 5 years after end of treatment

    Time frame: 5 years

    Medication use for allergy and asthma and the patient's experience of effect of the AIT on a scale from 0-4 (0= no effect, 1= modest effect, 2= some effect, 3= good effect, 4= very good effect)

Secondary outcomes

  1. Effect of immunotherapy 10 years after end of treatment

    Time frame: 10 years

    Medication use for allergy and asthma and the patient's experience of effect of the AIT on a scale from 0-4 (0= no effect, 1= modest effect, 2= some effect, 3= good effect, 4= very good effect)

Study contacts

Contact information is provided by the study sponsor or research team.

Josefine Gradman, PhD

CONTACT

[email protected]

0045 29241375

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2036
Study completion
2037
First posted
May 20, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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