Asthma, Conjunctivitis, Allergic, Rhinitis, Allergic
Conditions
Brief summary
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
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.
Interventions
DRUGSubcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
According to standardized clinical protocol
OTHERNo immunotherapy, symptomatic treatment
These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.
Sponsors
Karolinska Institutet
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open controlled study
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to a Conjunctival Allergen Challenge | Before treatment and after 12,24 and 36 months | Change in the dose of allergen needed to elicit a clinical response following ocular administration of the allergen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire regarding use of pharmacologic treatment for allergy and asthma during pollen season | Baseline and after 12,24 and 36 months of immunotherapy | 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 |
| Questionnaire regarding quality of life | Baseline and after 12,24 and 36 months of immunotherapy | 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 |
| PADQLQ (pediatric allergic disease quality of life questionnaire) in Swedish LILA | Baseline and after 12,24 and 36 months of immunotherapy | 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 |
| Change in level of IgG-antibodies | Baseline and after 12,24 and 36 months of immunotherapy | Difference in change between intervention and control group will be assessed |
| Change in level of IgG4-antibodies | Baseline and after 12,24 and 36 months of immunotherapy | Difference in change between intervention and control group will be assessed |
| Change in level of IgE-antibodies | Baseline and after 12,24 and 36 months of immunotherapy | Difference in change between intervention and control group will be assessed |
Countries
Sweden
Outcome results
None listed