Clinical trial NCT02640014: Oral Immunotherapy in Food Allergy in Finland
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Hypersensitivity
Immune System Diseases
Anaphylaxis
Keywords: 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)
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Long-term effectiveness as a measure of milk consumption (dl/day).
timeFrame: Ten years
Secondary outcomes:
measure: General health-related quality of life
timeFrame: One year
measure: Disease specific health-related quality of life
timeFrame: One year
measure: Cost-utility analysis and health benefits by measuring quality-adjusted life-years (QALYs).
timeFrame: One year
measure: Incidence of Treatment - Emergent Adverse Events
timeFrame: Ten years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Skin and Allergy Hospital
Study officials:
affiliation: Chief Physician, Helsinki University Hospital
name: Mika J Mäkelä, MD, PhD
role: STUDY_DIRECTOR
References: