Oral Immunotherapy in Food Allergy in Finland

Immune System Diseases Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02640014
• Other study ID #: U1020AL001
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anaphylaxis
• Food Hypersensitivity
• Hypersensitivity
• Immune System Diseases

Intervention

Dietary Supplement:
• Milk
Milk Oral immunotherapy

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Skin and Allergy Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term effectiveness as a measure of milk consumption (dl/day).	Consumption of milk (dl/day)	Ten years
Secondary	General health-related quality of life	To measure health-related quality of life by using a generic (Finnish 15-D questionnaire) before and one year after OIT.	One year
Secondary	Disease specific health-related quality of life	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.	One year
Secondary	Cost-utility analysis and health benefits by measuring quality-adjusted life-years (QALYs).	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.	One year
Secondary	Incidence of Treatment - Emergent Adverse Events	Severe adverse events	Ten years