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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy |
|
| Control group | Active Comparator | No immunotherapy, symptomatic treatment These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy | Drug | According to standardized clinical protocol |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Ingemansson, MD, PHD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26141262 | Result | Schmid JM, Wurtzen PA, Dahl R, Hoffmann HJ. Pretreatment IgE sensitization patterns determine the molecular profile of the IgG4 response during updosing of subcutaneous immunotherapy with timothy grass pollen extract. J Allergy Clin Immunol. 2016 Feb;137(2):562-70. doi: 10.1016/j.jaci.2015.05.023. Epub 2015 Jun 30. | |
| 21771081 | Result |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D003233 | Conjunctivitis, Allergic |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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Open controlled study
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| No immunotherapy, symptomatic treatment | Other | These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis. |
|
| 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 |
| Borres MP, Ebisawa M, Eigenmann PA. Use of allergen components begins a new era in pediatric allergology. Pediatr Allergy Immunol. 2011 Aug;22(5):454-61. doi: 10.1111/j.1399-3038.2011.01197.x. |
| 23498595 | Result | Burks AW, Calderon MA, Casale T, Cox L, Demoly P, Jutel M, Nelson H, Akdis CA. Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus report. J Allergy Clin Immunol. 2013 May;131(5):1288-96.e3. doi: 10.1016/j.jaci.2013.01.049. Epub 2013 Mar 14. |
| 20874810 | Result | Kiotseridis H, Cilio CM, Bjermer L, Aurivillius M, Jacobsson H, Tunsater A. Swedish translation and validation of the Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ). Acta Paediatr. 2011 Feb;100(2):242-7. doi: 10.1111/j.1651-2227.2010.02028.x. Epub 2010 Oct 18. |
| 16713521 | Result | Schmidt S, Debensason D, Muhlan H, Petersen C, Power M, Simeoni MC, Bullinger M; European DISABKIDS Group. The DISABKIDS generic quality of life instrument showed cross-cultural validity. J Clin Epidemiol. 2006 Jun;59(6):587-98. doi: 10.1016/j.jclinepi.2005.09.012. Epub 2006 May 2. |
| 27430124 | Result | Fauquert JL, Jedrzejczak-Czechowicz M, Rondon C, Calder V, Silva D, Kvenshagen BK, Callebaut I, Allegri P, Santos N, Doan S, Perez Formigo D, Chiambaretta F, Delgado L, Leonardi A; Interest Group on Ocular Allergy (IGOA) from the European Academy of Allergy and Clinical Immunology. Conjunctival allergen provocation test : guidelines for daily practice. Allergy. 2017 Jan;72(1):43-54. doi: 10.1111/all.12986. Epub 2016 Aug 18. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |