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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03079206
Other study ID # 2016-02152
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 22, 2017
Est. completion date November 10, 2020

Study information

Verified date November 2020
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components.


Description:

Accurate diagnosis of food allergy depends on food challenge outcome. The proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components to evaluate the diagnostic utility of basophile activation testing. With a view towards improved in vitro diagnostic methods, the investigators intend to evaluate the diagnostic potential of basophile activation testing in patients with hazelnut allergy confirmed by a positive provocation or supported by a convincing history of anaphylactic reaction(s) to hazelnut in the past, patients with pollinosis but no symptoms of hazelnut allergy and non-atopic control subjects.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date November 10, 2020
Est. primary completion date November 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: Primary Inclusion criteria: - Male and female subjects, age = 14 years - Informed Consent as documented by signature Secondary inclusion criterion - Group A: positive case history of allergic reaction(s) to hazelnut positive double-blind placebo-controlled food challenge with hazelnut or positive titrated open food challenge with hazelnut or unambiguous case history of an anaphylactic reaction after hazelnut will be included without provocation - Group B:positive skin test (SPT) with birch pollen and hazelnut and negative food provocation with hazelnut. - Group C: negative case history of hazelnut and birch allergy and negative skin test (SPT) with hazelnut and birch pollen and negative food provocation with hazelnut Exclusion Criteria: - Drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge): corticosteroids systemically (2 weeks), antihistamines (3 days), beta blocker (1 day), angiotensin converting enzyme (ACE) inhibitors (2 days), omalizumab (2 months) - Women who are pregnant - Lack of safe contraception - Uncontrolled asthma, forced expiratory volume (1 second) <70% predicted value - Acute allergic disease - Chronic urticaria - Mastocytosis - Other clinically significant concomitant disease states - Known or suspected non-compliance, drug or alcohol abuse, - Inability to follow the procedures of the study - Participation in another study with investigational drug within the 30 days preceding and during the present study

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Food challenge
food challenge with hazelnut
skin testing
Skin testing with hazelnut extract
blood sampling
blood sampling to perform basophile activation tests

Locations

Country Name City State
Switzerland Allergy Unit, Department of Dermatology, University Hospital Zürich

Sponsors (2)

Lead Sponsor Collaborator
University of Zurich ADR-AC Laboratory, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with challenge confirmed food allergy to hazelnut and a positive basophile activation test outcome of food challenge in hazelnut allergic patients will be compared to the outcome of basophile activation using hazelnut extract and allergens up to 3 years
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