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Oral Immunotherapy in Food Allergy in Finland

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ClinicalTrials.gov Identifier: NCT02640014
Recruitment Status : Active, not recruiting
First Posted : December 28, 2015
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Tiina Kauppila, MD, Helsinki University Central Hospital

Brief Summary:
The outcomes of oral immunotherapy (OIT) in food allergy study will provide more knowledge of oral immunotherapy. So far the OIT has showed in clinical experiments to be a interesting way to increase the unresponsiveness in severe food allergies. However little is known about it´s long-term outcomes, immunological mechanisms and there are no previous studies about cost-utility of OIT.

Condition or disease Intervention/treatment Phase
Food Hypersensitivity Immune System Diseases Anaphylaxis Dietary Supplement: Milk Not Applicable

Detailed Description:

The purpose of the present study is to examine the outcomes of the food oral immunotherapy on patients with severe food allergy in the three different subprojects:

Study 1: Long-term follow up after milk oral immunotherapy. The measured outcomes are long-term effectiveness (e.g. health-related quality of life), safety of desensitization and immunological changes.

Study 2: Measure health-related quality of life with disease-specific and generic questionnaire. The aim of this study is to define the suitability of the FAQLQ and the 15-D questionnaires for the Finnish food allergic patients. Another purpose of this study is to examine the relationship between FAQLQ and 15-D questionnaires.

Study 3: QALYs. This is called the cost-utility analyses and QALYs and its purpose is to calculate the cost of OIT and to define the cost-effectiveness of OIT by measuring QALYs. To our knowledge this will be the first pilot study to define the QALYs in food oral immunotherapy. The aim is to have 50-100 patients. The literature in other areas of medicine 50-100 patients in QALY-publishing is quite plain.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Specific Oral Immunotherapy in Food Allergy - Real-life Long-term Follow up (After Milk Oral Immunotherapy), Effect on Health-related Quality of Life and Cost-utility Analyses
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study 1: Milk OIT follow up
Follow up on patient with severe milk allergy how have participated to milk OIT.
Dietary Supplement: Milk
Milk Oral immunotherapy

No Intervention: Study 1: Follow up
Follow up on patient with severe milk allergy how have not participated to milk OIT.



Primary Outcome Measures :
  1. Long-term effectiveness as a measure of milk consumption (dl/day). [ Time Frame: Ten years ]
    Consumption of milk (dl/day)


Secondary Outcome Measures :
  1. General health-related quality of life [ Time Frame: One year ]
    To measure health-related quality of life by using a generic (Finnish 15-D questionnaire) before and one year after OIT.

  2. Disease specific health-related quality of life [ Time Frame: One year ]
    To measure health-related quality of life by using a disease specific questionnaires (Food Allergy Quality of Life Questionnaires, FAQLQ) before and one year after OIT.

  3. Cost-utility analysis and health benefits by measuring quality-adjusted life-years (QALYs). [ Time Frame: One year ]
    A Pilot study to define the cost of OIT and define the cost of quality-adjusted life-years (QALYs) with generic health-realted quality of life scale 15-D-questionnaire.

  4. Incidence of Treatment - Emergent Adverse Events [ Time Frame: Ten years ]
    Severe adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Study 1: All the children have been eligible to participate milk OIT during the years 2005-2015.
  • Study 2 + 3: Patients will start OIT treatment (to milk / egg / peanut).

Exclusion Criteria:

  • Not willing to participate
  • Active asthma, low lung function, pregnancy, cardiovascular or other disease that might worsen during the OIT.

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): NCT02640014


Locations
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Finland
Helsinki University Central Hospital, Skin and Allergy Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Study Director: Mika J Mäkelä, MD, PhD Chief Physician, Helsinki University Hospital

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Responsible Party: Tiina Kauppila, MD, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02640014     History of Changes
Other Study ID Numbers: U1020AL001
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tiina Kauppila, MD, Helsinki University Central Hospital:
Food allergy
Health-related quality of life (HRQL)
Quality-adjusted life-years (QALYs)
Oral immunotherapy (OIT)
Cow´s milk allergy (CMA)
Milk oral immunotherapy (MOIT)

Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Anaphylaxis
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs