Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

Study Overview
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Brief Summary
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The objective is to prospectively explore associations between immunological parameters in blood and clinical effect of subcutaneous immunotherapy (SCIT) in children with severe allergy towards pollen. Half of the children will receive SCIT while the other half will start SCIT after the study is finished. Clinical evaluations of symptoms and an immunological survey will be performed before start of SCIT and after one year of treatment. Some of the immunological parameters will also be checked after 6 months of treatment

Detailed Description
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Before start of SCIT, with Alutard pollenextract/s from  Allergologisk Laboratorium Köbenhavn (ALK), and after one year of treatment, immunoglobulin E (IgE)-antibody levels towards the crude allergen and important allergen components in birch and grasspollen (timothy) will be measured in blood. While IgE- antibodies are considered to be an indicator of allergy IgG- and IgG4-antibodies are considered to be blocking antibodies in IgE-mediated allergy. Therefore the investigators will measure the IgG- and IgG4-antibody levels to crude allergens and applicable allergen components before start, when maintenance dose is reached (after 6 months) and after one year of treatment. In order to evaluate quality of life, a validated form (DISABKIDS) will be used. Symptom score will be rated by a validated form (LILA). The need for medication to treat allergic rhinitis and asthma will be assessed using questionnaires. A conjunctival provocation with the applicable allergen(s) will be performed before start of SCIT and after one year of treatment.

Official Title
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Evaluation of Clinical and Immunological Parameters in Children Treated With Subcutaneous Immunotherapy Towards Pollen - a Controlled Study

Conditions
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Rhinitis, Allergic, Conjunctivitis, Allergic, Asthma

Intervention / Treatment
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* Drug: Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
* Other: No immunotherapy, symptomatic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seasonal Rhinoconjunctivitis caused by grass and/or birch pollen allergy Insufficient clinical effect of symptomatic treatment (antihistamine, nasal corticosteroids) IgE antibodies to grass and/or birch pollen antigens Exclusion Criteria: severe comorbidity, severe asthma, pregnancy

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy | Drug: Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy<br>* According to standardized clinical protocol<br>* Other names: Subcutaneous immunotherapy with grass and/or birch;|
| Active Comparator: Control group<br>No immunotherapy, symptomatic treatment These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis. | Other: No immunotherapy, symptomatic treatment<br>* These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to a Conjunctival Allergen Challenge | Change in the dose of allergen needed to elicit a clinical response following ocular administration of the allergen | Before treatment and after 12,24 and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PADQLQ (pediatric allergic disease quality of life questionnaire) in Swedish LILA | Includes 26 questions regarding allergic symptoms scored from 0 (no symptoms) to 6 (very severe symptoms) during pollen season. Difference in change of total score between intervention and control group will be assessed | Baseline and after 12,24 and 36 months of immunotherapy | 
| Questionnaire regarding use of pharmacologic treatment for allergy and asthma during pollen season | Frequency of use of 8 different drugs will be scored from 0(never) to 5 (daily). Difference in change of total score between intervention and control group will be assessed | Baseline and after 12,24 and 36 months of immunotherapy | 
| Questionnaire regarding quality of life | DISABKIDS, a european quality of life questionnaire used in children with chronic diseases consisting of 37 quality of life questions with answers rated from ever (0=best) to never (5= worst). Difference in change of total score between intervention and control group will be assessed | Baseline and after 12,24 and 36 months of immunotherapy | 
| Change in level of IgE-antibodies | Difference in change between intervention and control group will be assessed | Baseline and after 12,24 and 36 months of immunotherapy | 
| Change in level of IgG-antibodies | Difference in change between intervention and control group will be assessed | Baseline and after 12,24 and 36 months of immunotherapy | 
| Change in level of IgG4-antibodies | Difference in change between intervention and control group will be assessed | Baseline and after 12,24 and 36 months of immunotherapy |