Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

Karolinska Institute

Status: Completed

Conditions: Asthma; Conjunctivitis, Allergic; Rhinitis, Allergic

Treatments: Drug: Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy; Other: No immunotherapy, symptomatic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03375775

DNR 2015/3:8 EPN Stockholm

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Treatment group

Experimental group

Description:

Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy

Treatment:

Drug: Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy

Control group

Active Comparator group

Description:

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

Treatment:

Other: No immunotherapy, symptomatic treatment