Long Term Effect of AIT in Children

Recruiting

• Conditions: Allergy in Children

• Registration Number: NCT06421415
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-01
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-20
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-28
• Primary Completion: 2036-12-01
• Study Completion: 2037-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

received less than 12 months of treatment with allergen immunotherapy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of immunotherapy 5 years after end of treatment	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 Outcome Measures

Name	Time	Method
Effect of immunotherapy 10 years after end of treatment	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)

Trial Locations

Locations (1)

Hans Christian Andersen Children's Hospital; 🇩🇰 Odense, Denmark