Clinical trial NCT03375775: Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children
Official title: Evaluation of Clinical and Immunological Parameters in Children Treated With Subcutaneous Immunotherapy Towards Pollen - a Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinitis, Allergic
Conjunctivitis, Allergic
Asthma
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open controlled study
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response to a Conjunctival Allergen Challenge
timeFrame: Before treatment and after 12,24 and 36 months
Secondary outcomes:
measure: PADQLQ (pediatric allergic disease quality of life questionnaire) in Swedish LILA
timeFrame: Baseline and after 12,24 and 36 months of immunotherapy
measure: Questionnaire regarding use of pharmacologic treatment for allergy and asthma during pollen season
timeFrame: Baseline and after 12,24 and 36 months of immunotherapy
measure: Questionnaire regarding quality of life
timeFrame: Baseline and after 12,24 and 36 months of immunotherapy
measure: Change in level of IgE-antibodies
timeFrame: Baseline and after 12,24 and 36 months of immunotherapy
measure: Change in level of IgG-antibodies
timeFrame: Baseline and after 12,24 and 36 months of immunotherapy
measure: Change in level of IgG4-antibodies
timeFrame: Baseline and after 12,24 and 36 months of immunotherapy
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Maria Ingemansson, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.