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Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT03375775
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
57
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
  • Other: No immunotherapy, symptomatic treatment
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Open controlled studyOpen controlled study
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of Clinical and Immunological Parameters in Children Treated With Subcutaneous Immunotherapy Towards Pollen - a Controlled Study
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Jan 31, 2022
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy

Drug: Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
According to standardized clinical protocol
Other Names:
  • Subcutaneous immunotherapy with grass and/or birch

    		•
    Active Comparator: Control group

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

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    6. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karolinska University Hospital Stockholm Sweden

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

    • Principal Investigator: Maria Ingemansson, MD, PHD, Karolinska Institutet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maria Ingemansson, Principal Investigator, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT03375775
    Other Study ID Numbers:
    • DNR 2015/3:8 EPN Stockholm
    First Posted:
    Dec 18, 2017
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Rhinitis
    Rhinitis, Allergic
    Conjunctivitis
    Conjunctivitis, Allergic
    Immunologic Factors

    Study Results

    No Results Posted as of Apr 5, 2022