## Protocol Section
### Identification Module
**NCT ID:** NCT06421415

**Brief Title:** Long Term Effect of AIT in Children

**Official Title:** Long Term Effect of AIT in Children

#### Organization Study ID Info
**ID:** HCA-AIT
#### Organization
**Class:** OTHER
**Full Name:** Odense University Hospital
### Status Module
#### Completion Date
**Date:** 2037-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2036-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Odense University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Allergy in Children

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 14 Years

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** Allergen Immunotherapy Extract

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Effect of immunotherapy 5 years after end of treatment

**Time Frame:** 5 years

#### Secondary Outcomes

**Description:** 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)

**Measure:** Effect of immunotherapy 10 years after end of treatment

**Time Frame:** 10 years

### Eligibility Module

**Eligibility Criteria:** 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

-

**Maximum Age:** 18 Years

**Minimum Age:** 4 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** josefine.gradman@rsyd.dk

**Name:** Josefine Gradman, PhD

**Phone:** 0045 29241375

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Odense

**Contacts:**

***Contact 1:***

- **Email:** j.gradman@dadlnet.dk

- **Name:** Josefine Gradman

- **Phone:** 004529241375

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Hans Christian Andersen Children's Hospital

**State:** Odense C

**Status:** RECRUITING

**Zip:** 5000

**Location 2:**

**City:** Odense

**Contacts:**

***Contact 1:***

- **Email:** josefine.gradman@rsyd.dk

- **Name:** Josefine Gradman, PhD

- **Phone:** 0045 29241375

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Hans Christian Andersen Children's Hospital

**Status:** RECRUITING

**Zip:** 5000

#### Overall Officials

**Official 1:**

**Affiliation:** Odense University Hospital

**Name:** Josefine Gradman, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: HIGH

- As Found: CAR-

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000091369

- Term: Immunomodulating Agents

### Misc Info Module

- Version Holder: 2024-05-31
