Allergy in ChildrenNCT06421415
Long Term Effect of AIT in Children
An observational study of Allergy in Children, run by Odense University Hospital at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Allergy in Children
- What is being tested?
- Allergen Immunotherapy Extract
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2024to 1 May 2037
- How long will I take part?
- 14 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with moderate to severe allergy to grass pollen, birch, house dust mites or venom who are prescribed allergen immunotherapy
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
-
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Hans Christian Andersen Children's Hospital
Odense, Odense C, 5000
Josefine Gradman, 004529241375, j.gradman@dadlnet.dk
- Recruiting
Hans Christian Andersen Children's Hospital
Odense, 5000
Josefine Gradman, PhD, 0045 29241375, josefine.gradman@rsyd.dk
About this study
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.
Read the 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.
- Conditions
- Allergy in Children
- Being tested
- Allergen Immunotherapy Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen Immunotherapy ExtractDrug
Patients will be treated as usual. The study is an observation of the long term effect of the treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 years
Secondary outcomes (1)
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)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 May 2024
- Primary completion1 Dec 2036 (estimated)
- Study completion1 May 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 14 Years
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josefine Gradman, PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421415
- Sponsor's protocol ID
- HCA-AIT
- Status last verified
- Oct 2026
- First submitted
- 14 May 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No