Status:
COMPLETED
Study to Evaluate the Potential of Air Structuring Protein to Elicit Allergic Reactions in Mold Sensitized People
Lead Sponsor:
Unilever SEAC
Conditions:
Allergy to Mold
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT01494194
Start Date
December 1 2011
End Date
July 1 2012
Last Update
June 8 2015
Active Locations (1)
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1
National Heart and Lung Institute, MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, Centre for Respiratory Infection, Imperial College London
London, United Kingdom, W2 1PG