Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03375775
Recruitment Status : Active, not recruiting
First Posted : December 18, 2017
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Ingemansson, Karolinska Institutet

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
Rhinitis, Allergic Conjunctivitis, Allergic Asthma Drug: Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy Other: No immunotherapy, symptomatic treatment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open 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
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375775


Locations
Layout table for location information
Sweden
Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Principal Investigator: Maria Ingemansson, MD, PHD Karolinska Institutet

Publications of Results:

Layout table for additonal information
Responsible Party: Maria Ingemansson, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03375775     History of Changes
Other Study ID Numbers: DNR 2015/3:8 EPN Stockholm
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Immunologic Factors
Rhinitis
Rhinitis, Allergic
Conjunctivitis
Conjunctivitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Physiological Effects of Drugs