Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

Not Applicable

Completed

• Conditions: Rhinitis, Allergic; Conjunctivitis, Allergic; Asthma
• Interventions: Drug: Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy; Other: No immunotherapy, symptomatic treatment

• Registration Number: NCT03375775
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-18
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-03
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• severe comorbidity, severe asthma, pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy	Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
Control group	No immunotherapy, symptomatic treatment	No immunotherapy, symptomatic treatment These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 IgG4-antibodies	Baseline and after 12,24 and 36 months of immunotherapy	Difference in change 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
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
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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden