NCT03375775

Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis, Allergic
• Conjunctivitis, Allergic
• Asthma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-01
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2017-12-18
• Last updated: 2022-04-05

Locations

1 site across 1 country: Sweden