Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 10:43 AM
Study NCT ID:
NCT01494194
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2011-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Potential of Air Structuring Protein to Elicit Allergic Reactions in Mold Sensitized People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-05', 'studyFirstSubmitDate': '2011-12-12', 'studyFirstSubmitQcDate': '2011-12-14', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive skin prick test response to test material', 'timeFrame': '15 minutes after application', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The number of positive Double Blind Placebo Controlled Food Challenge reactions in those with positive skin prick test result', 'timeFrame': '2 hours after administration', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mold sensitized'], 'conditions': ['Allergy to Mold']}, 'descriptionModule': {'briefSummary': '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.\n\nToxicological 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.\n\nAs 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:\n\n* Whether ASP has the potential to elicit a positive skin prick test (SPT) in a population of participants with proven sensitivity to mould.\n* Whether ASP is responsible for any positive SPT reactions, should they occur.\n* And if any positive SPT reactions to ASP occur, whether such reactions are clinically relevant with respect to food allergy.\n\nThe 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.\n\nIn 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.\n\nThis is a multi centre study which is taking place in the UK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 18-60 years.\n* Mould sensitised subjects diagnosed according to the EAACI/Ga2len guidelines.\n* Written informed consent from the subject.\n* Normally active and otherwise judged to be in good health on the basis of medical history and screening assessment.\n* No allergic symptoms on the day of investigation.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Failure to comply with the protocol.\n* Medication that may interfere with wheal formation in the skin or response to DBPCFC\n* Participation in another clinical study involving a SPT within 30 days prior to Visit 1 or DBPCFC within 30 days prior to DBPCFC.\n* Current skin disease of any type (eczema, acne, dermatitis, etc.) on the test site(s).\n* 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.'}, 'identificationModule': {'nctId': 'NCT01494194', 'briefTitle': 'Study to Evaluate the Potential of Air Structuring Protein to Elicit Allergic Reactions in Mold Sensitized People', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unilever SEAC'}, 'officialTitle': 'Evaluation of the Potential of Air Structuring Protein, a Novel Protein Preparation Derived From Trichoderma Reesei, to Elicit Allergic Reactions in Mold Sensitized People', 'orgStudyIdInfo': {'id': 'KQC100140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo for food challenge', 'interventionNames': ['Other: Placebo sorbet']}, {'type': 'EXPERIMENTAL', 'label': 'ASP Skin prick solution', 'interventionNames': ['Other: Air Structuring Protein']}, {'type': 'EXPERIMENTAL', 'label': 'ASP sorbet', 'interventionNames': ['Other: Air Structuring Protein']}], 'interventions': [{'name': 'Air Structuring Protein', 'type': 'OTHER', 'description': 'A novel food protein preparation', 'armGroupLabels': ['ASP Skin prick solution', 'ASP sorbet']}, {'name': 'Placebo sorbet', 'type': 'OTHER', 'description': 'Placebo sorbet for double blind placebo controlled food challenge', 'armGroupLabels': ['placebo for food challenge']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'National Heart and Lung Institute, MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, Centre for Respiratory Infection, Imperial College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unilever SEAC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}