Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375775
• Other study ID #: DNR 2015/3:8 EPN Stockholm
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
According to standardized clinical protocol

Other:
• No immunotherapy, symptomatic treatment
These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. Review. — View 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 — View 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 Aller — View Citation

Kiotseridis H, Cilio CM, Bjermer L, Aurivillius M, Jacobsson H, Tunsäter 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.1651-2227.2010.02 — View Citation

Schmid JM, Würtzen 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( — View Citation

Schmidt S, Debensason D, Mühlan 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. Epub 2006 May 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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