Study to Evaluate the Potential of Air Structuring Protein to Elicit Allergic Reactions in Mold Sensitized People

Study Overview
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Brief Summary
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Air Structuring Protein (ASP) is a small protein derived from a fungus which is already widely used to produce enzymes that are added to foods. ASP has the possibility of stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential ice-cream ingredient. Toxicological tests have also been carried out to further confirm the safety of the material and no evidence of genotoxicity or acute toxicity has been observed in any of the tests. As part of the safety evaluation of a new protein for use in foods, the potential allergenicity is also investigated and Unilever is sponsoring a study to evaluate this aspect of ASP. This study will investigate: Whether ASP has the potential to elicit a positive skin prick test (SPT) in a population of participants with proven sensitivity to mould. Whether ASP is responsible for any positive SPT reactions, should they occur. And if any positive SPT reactions to ASP occur, whether such reactions are clinically relevant with respect to food allergy. The study is divided in three stages. In Stage 1 and Stage 2, the SPT is open label, which means that both the participant and the study doctor will know which materials are being tested. In Stage 3, the food challenge has a crossover design, meaning that participants will take one of the products (ASP or placebo [food containing no ASP]) during the first half of the study and the other treatment during the second half. The order of ASP and placebo will be decided randomly, like tossing a coin. To make the comparison between ASP and placebo as fair as possible, the food challenge is double blinded. This means that neither the participant nor the study doctor will know which kind of products (ASP or placebo) the participant is taking. This is a multi centre study which is taking place in the UK.

Official Title
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Evaluation of the Potential of Air Structuring Protein, a Novel Protein Preparation Derived From Trichoderma Reesei, to Elicit Allergic Reactions in Mold Sensitized People

Conditions
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Allergy to Mold

Intervention / Treatment
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* Other: Air Structuring Protein
* Other: Placebo sorbet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 18-60 years. Mould sensitised subjects diagnosed according to the EAACI/Ga2len guidelines. Written informed consent from the subject. Normally active and otherwise judged to be in good health on the basis of medical history and screening assessment. No allergic symptoms on the day of investigation. Exclusion Criteria: Pregnancy or lactation. Failure to comply with the protocol. Medication that may interfere with wheal formation in the skin or response to DBPCFC Participation in another clinical study involving a SPT within 30 days prior to Visit 1 or DBPCFC within 30 days prior to DBPCFC. Current skin disease of any type (eczema, acne, dermatitis, etc.) on the test site(s). Subjects with a condition the Investigator believes would interfere with the evaluation of the subject, including proceeding to DBPCFC, or may put the subject at undue risk, e.g., a history of anaphylactic reactions and history of reactions to any component of the DBPCFC matrix other than ASP.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo for food challenge<br> | Other: Placebo sorbet<br>* Placebo sorbet for double blind placebo controlled food challenge<br>|
| Experimental: ASP Skin prick solution<br> | Other: Air Structuring Protein<br>* A novel food protein preparation<br>|
| Experimental: ASP sorbet<br> | Other: Air Structuring Protein<br>* A novel food protein preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive skin prick test response to test material | The number and size of positive SPTs will be recorded together with data of concomitant allergies and the minimum eliciting concentration (SPT-min) in the skin. | 15 minutes after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of positive Double Blind Placebo Controlled Food Challenge reactions in those with positive skin prick test result | The number of positive DBPCFC reactions will be recorded together with pre and post challenge blood pressure, pulse rate, peak expiratory flow (PEF) and forced expiratory volume (FEV1), data of concomitant allergies, any symptoms elicited including any late onset reactions, timing of symptoms and the minimum eliciting dose of ASP. | 2 hours after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mold sensitized