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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
According to standardized clinical protocol
These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.
Karolinska University Hospital
Stockholm, Sweden
Response to a Conjunctival Allergen Challenge
Change in the dose of allergen needed to elicit a clinical response following ocular administration of the allergen
Time frame: Before treatment and after 12,24 and 36 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: Baseline and after 12,24 and 36 months of immunotherapy