Long Term Effect of AIT in Children

Allergy in Children Clinical Trial

Official title:

Long Term Effect of AIT in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06421415
• Other study ID #: HCA-AIT
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: May 1, 2037

Study information

• Verified date: May 2024
• Source: Odense University Hospital
• Contact: Josefine Gradman, PhD
• Phone: 0045 29241375
• Email: josefine.gradman[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2037
• Est. primary completion date: December 1, 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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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Related Conditions & MeSH terms

• Allergy in Children

Intervention

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

Locations

Country	Name	City	State
Denmark	Hans Christian Andersen Children's Hospital	Odense	Odense C
Denmark	Hans Christian Andersen Children's Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of immunotherapy 5 years after end of treatment	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)	5 years
Secondary	Effect of immunotherapy 10 years after end of treatment	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)	10 years