Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2022-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Rhinitis, Allergic Conjunctivitis, Allergic Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Open controlled study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment group

Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy

Group Type EXPERIMENTAL

Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy

Intervention Type DRUG

According to standardized clinical protocol

Control group

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

Group Type ACTIVE_COMPARATOR

No immunotherapy, symptomatic treatment

Intervention Type OTHER

These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.

Interventions

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Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy

According to standardized clinical protocol

Intervention Type DRUG

No immunotherapy, symptomatic treatment

These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.

Intervention Type OTHER

Other Intervention Names

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Subcutaneous immunotherapy with grass and/or birch

Eligibility Criteria

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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