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.

Study Overview

• Status: Recruiting
• Conditions: Allergy in Children
• Intervention / Treatment: Drug: Allergen Immunotherapy Extract

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Josefine Gradman, PhD; Phone Number: 0045 29241375; Email: josefine.gradman@rsyd.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Recruiting
    • Hans Christian Andersen Children's Hospital
    • Contact: Josefine Gradman, PhD; Phone Number: 0045 29241375; Email: josefine.gradman@rsyd.dk
  • Odense C
    • Odense, Odense C, Denmark, 5000
      • Recruiting
      • Hans Christian Andersen Children's Hospital
      • Contact: Josefine Gradman; Phone Number: 004529241375; Email: j.gradman@dadlnet.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children with moderate to severe allergy to grass pollen, birch, house dust mites or venom who are prescribed allergen immunotherapy

Description

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

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Josefine Gradman, PhD, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): May 1, 2037

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: HCA-AIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No