NCT06421415

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
133mo left

Started May 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
May 2024May 2037

Study Start

First participant enrolled

May 1, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2036

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2037

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

12.6 years

First QC Date

May 14, 2024

Last Update Submit

July 7, 2025

Conditions

Allergy in Children

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Effect of immunotherapy 10 years after end of treatment

    10 years

Interventions

Allergen Immunotherapy ExtractDRUG

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

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hans Christian Andersen Children's Hospital

Odense, Odense C, 5000, Denmark

RECRUITING

Hans Christian Andersen Children's Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Interventions

Desensitization, Immunologic

Intervention Hierarchy (Ancestors)

Immunosuppression TherapyImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Josefine Gradman, PhD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Josefine Gradman, PhD

CONTACT

0045 29241375josefine.gradman@rsyd.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 20, 2024

Study Start

May 1, 2024

Primary Completion (Estimated)

December 1, 2036

Study Completion (Estimated)

May 1, 2037

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)