Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

April 3, 2022 updated by: Maria Ingemansson, Karolinska Institutet

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before treatment and after 12,24 and 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and after 12,24 and 36 months of immunotherapy
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
Baseline and after 12,24 and 36 months of immunotherapy
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
Baseline and after 12,24 and 36 months of immunotherapy
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
Baseline and after 12,24 and 36 months of immunotherapy
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
Baseline and after 12,24 and 36 months of immunotherapy
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
Baseline and after 12,24 and 36 months of immunotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 3, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNR 2015/3:8 EPN Stockholm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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