Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children
Primary Purpose
Rhinitis, Allergic, Conjunctivitis, Allergic, Asthma
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
No immunotherapy, symptomatic treatment
Sponsored by
About this trial
This is an interventional other trial for Rhinitis, Allergic
Eligibility 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
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment group
Control group
Arm Description
Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
No immunotherapy, symptomatic treatment These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.
Outcomes
Primary Outcome Measures
Response to a Conjunctival Allergen Challenge
Change in the dose of allergen needed to elicit a clinical response following ocular administration of the allergen
Secondary Outcome Measures
PADQLQ (pediatric allergic disease quality of life questionnaire) in Swedish LILA
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
Questionnaire regarding use of pharmacologic treatment for allergy and asthma during pollen season
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
Questionnaire regarding quality of life
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
Change in level of IgE-antibodies
Difference in change between intervention and control group will be assessed
Change in level of IgG-antibodies
Difference in change between intervention and control group will be assessed
Change in level of IgG4-antibodies
Difference in change between intervention and control group will be assessed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03375775
Brief Title
Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children
Official Title
Evaluation of Clinical and Immunological Parameters in Children Treated With Subcutaneous Immunotherapy Towards Pollen - a Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
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
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Conjunctivitis, Allergic, Asthma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open controlled study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
No immunotherapy, symptomatic treatment These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.
Intervention Type
Drug
Intervention Name(s)
Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
Other Intervention Name(s)
Subcutaneous immunotherapy with grass and/or birch
Intervention Description
According to standardized clinical protocol
Intervention Type
Other
Intervention Name(s)
No immunotherapy, symptomatic treatment
Intervention Description
These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.
Primary Outcome Measure Information:
Title
Response to a Conjunctival Allergen Challenge
Description
Change in the dose of allergen needed to elicit a clinical response following ocular administration of the allergen
Time Frame
Before treatment and after 12,24 and 36 months
Secondary Outcome Measure Information:
Title
PADQLQ (pediatric allergic disease quality of life questionnaire) in Swedish LILA
Description
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
Time Frame
Baseline and after 12,24 and 36 months of immunotherapy
Title
Questionnaire regarding use of pharmacologic treatment for allergy and asthma during pollen season
Description
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
Time Frame
Baseline and after 12,24 and 36 months of immunotherapy
Title
Questionnaire regarding quality of life
Description
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
Time Frame
Baseline and after 12,24 and 36 months of immunotherapy
Title
Change in level of IgE-antibodies
Description
Difference in change between intervention and control group will be assessed
Time Frame
Baseline and after 12,24 and 36 months of immunotherapy
Title
Change in level of IgG-antibodies
Description
Difference in change between intervention and control group will be assessed
Time Frame
Baseline and after 12,24 and 36 months of immunotherapy
Title
Change in level of IgG4-antibodies
Description
Difference in change between intervention and control group will be assessed
Time Frame
Baseline and after 12,24 and 36 months of immunotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Ingemansson, MD, PHD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26141262
Citation
Schmid JM, Wurtzen PA, Dahl R, Hoffmann HJ. Pretreatment IgE sensitization patterns determine the molecular profile of the IgG4 response during updosing of subcutaneous immunotherapy with timothy grass pollen extract. J Allergy Clin Immunol. 2016 Feb;137(2):562-70. doi: 10.1016/j.jaci.2015.05.023. Epub 2015 Jun 30.
Results Reference
result
PubMed Identifier
21771081
Citation
Borres MP, Ebisawa M, Eigenmann PA. Use of allergen components begins a new era in pediatric allergology. Pediatr Allergy Immunol. 2011 Aug;22(5):454-61. doi: 10.1111/j.1399-3038.2011.01197.x.
Results Reference
result
PubMed Identifier
23498595
Citation
Burks AW, Calderon MA, Casale T, Cox L, Demoly P, Jutel M, Nelson H, Akdis CA. Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus report. J Allergy Clin Immunol. 2013 May;131(5):1288-96.e3. doi: 10.1016/j.jaci.2013.01.049. Epub 2013 Mar 14.
Results Reference
result
PubMed Identifier
20874810
Citation
Kiotseridis H, Cilio CM, Bjermer L, Aurivillius M, Jacobsson H, Tunsater A. Swedish translation and validation of the Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ). Acta Paediatr. 2011 Feb;100(2):242-7. doi: 10.1111/j.1651-2227.2010.02028.x. Epub 2010 Oct 18.
Results Reference
result
PubMed Identifier
16713521
Citation
Schmidt S, Debensason D, Muhlan H, Petersen C, Power M, Simeoni MC, Bullinger M; European DISABKIDS Group. The DISABKIDS generic quality of life instrument showed cross-cultural validity. J Clin Epidemiol. 2006 Jun;59(6):587-98. doi: 10.1016/j.jclinepi.2005.09.012. Epub 2006 May 2.
Results Reference
result
PubMed Identifier
27430124
Citation
Fauquert JL, Jedrzejczak-Czechowicz M, Rondon C, Calder V, Silva D, Kvenshagen BK, Callebaut I, Allegri P, Santos N, Doan S, Perez Formigo D, Chiambaretta F, Delgado L, Leonardi A; Interest Group on Ocular Allergy (IGOA) from the European Academy of Allergy and Clinical Immunology. Conjunctival allergen provocation test : guidelines for daily practice. Allergy. 2017 Jan;72(1):43-54. doi: 10.1111/all.12986. Epub 2016 Aug 18.
Results Reference
result
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Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children
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