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NCT Number: NCT03375775

Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

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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Key information

Conditions

Rhinitis, Allergic Asthma Bronchial Diseases Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy

Drug

According to standardized clinical protocol

Other names: Subcutaneous immunotherapy with grass and/or birch

No immunotherapy, symptomatic treatment

Other

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

Primary outcomes

  1. Response to a Conjunctival Allergen Challenge

    Time frame: 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 outcomes

  1. PADQLQ (pediatric allergic disease quality of life questionnaire) in Swedish LILA

    Time frame: 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

  2. Questionnaire regarding use of pharmacologic treatment for allergy and asthma during pollen season

    Time frame: 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

  3. Questionnaire regarding quality of life

    Time frame: 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

  4. Change in level of IgE-antibodies

    Time frame: Baseline and after 12,24 and 36 months of immunotherapy

    Difference in change between intervention and control group will be assessed

  5. Change in level of IgG-antibodies

    Time frame: Baseline and after 12,24 and 36 months of immunotherapy

    Difference in change between intervention and control group will be assessed

  6. Change in level of IgG4-antibodies

    Time frame: Baseline and after 12,24 and 36 months of immunotherapy

    Difference in change between intervention and control group will be assessed

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 18, 2017
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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