Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

NCT03375775 | Completed

• 1 other identifier: DNR 2015/3:8 EPN Stockholm
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Rhinitis, Allergic; Conjunctivitis, Allergic; Asthma

Outcome Measures

Primary Outcomes (1)

• Response to a Conjunctival Allergen Challenge

  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 Outcomes (6)

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

  Baseline and after 12,24 and 36 months of immunotherapy

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

  Baseline and after 12,24 and 36 months of immunotherapy

• Questionnaire regarding quality of life

  Baseline and after 12,24 and 36 months of immunotherapy

• Change in level of IgE-antibodies

  Baseline and after 12,24 and 36 months of immunotherapy

• Change in level of IgG-antibodies

  Baseline and after 12,24 and 36 months of immunotherapy

Study Arms (2)

Treatment group

EXPERIMENTAL

Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy

Drug: Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy

Control group

ACTIVE COMPARATOR

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

Other: No immunotherapy, symptomatic treatment

Interventions

Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy DRUG

According to standardized clinical protocol

Also known as: Subcutaneous immunotherapy with grass and/or birch

Treatment group

No immunotherapy, symptomatic treatment OTHER

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

Control group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• severe comorbidity, severe asthma, pregnancy

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (6)

• 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.

  PMID: 26141262 RESULT

• 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.

  PMID: 21771081 RESULT

• 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.

  PMID: 23498595 RESULT

• 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.

  PMID: 20874810 RESULT

• 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.

  PMID: 16713521 RESULT

• 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.

  PMID: 27430124 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic; Conjunctivitis, Allergic; Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria Ingemansson, MD, PHD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open controlled study

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: December 18, 2017
• Study Start: May 1, 2017
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)