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Rhinitis, AllergicNCT03375775

Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

A study testing Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy and No immunotherapy, symptomatic treatment in people with Rhinitis, Allergic and Conjunctivitis, Allergic, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 years
What is being tested?
Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy and No immunotherapy, symptomatic treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSweden
Study dates
1 May 2017to 31 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • severe comorbidity, severe asthma, pregnancy

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska University Hospital

    Stockholm

Other trials in Sweden

About this study

Official title: 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

Read the 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.

Being tested
Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy, No immunotherapy, symptomatic treatment
Medical subject headings
Rhinitis, Allergic, Conjunctivitis, Allergic, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothyDrug

    Also called Subcutaneous immunotherapy with grass and/or birch

    According to standardized clinical protocol

  • No immunotherapy, symptomatic treatmentOther

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

Study groups in NCT03375775
Study groupRoleWhat they receive
Treatment groupExperimentalSubcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
Receives: Drug: Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy
Control groupActive comparatorNo immunotherapy, symptomatic treatment These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.
Receives: Other: No immunotherapy, symptomatic treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Before treatment and after 12,24 and 36 months

Secondary outcomes (6)

  1. 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

    Measured: Baseline and after 12,24 and 36 months of immunotherapy

  2. 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

    Measured: Baseline and after 12,24 and 36 months of immunotherapy

  3. 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

    Measured: Baseline and after 12,24 and 36 months of immunotherapy

  4. Change in level of IgE-antibodies

    Difference in change between intervention and control group will be assessed

    Measured: Baseline and after 12,24 and 36 months of immunotherapy

  5. Change in level of IgG-antibodies

    Difference in change between intervention and control group will be assessed

    Measured: Baseline and after 12,24 and 36 months of immunotherapy

  6. Change in level of IgG4-antibodies

    Difference in change between intervention and control group will be assessed

    Measured: Baseline and after 12,24 and 36 months of immunotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2017
  2. Study start1 May 2017
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Open controlled study
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03375775
Sponsor's protocol ID
DNR 2015/3:8 EPN Stockholm
Status last verified
Apr 2022
First submitted
3 Nov 2017
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26141262

  • 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.

    PubMed 21771081

  • 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.

    PubMed 23498595

  • 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.

    PubMed 20874810

  • 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.

    PubMed 16713521

  • 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.

    PubMed 27430124

Questions about this trial

What is this clinical trial studying?

A study testing Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy and No immunotherapy, symptomatic treatment in people with Rhinitis, Allergic and Conjunctivitis, Allergic, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to a Conjunctival Allergen Challenge (time frame: Before treatment and after 12,24 and 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03375775, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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