Status:
COMPLETED
Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus
Lead Sponsor:
Roxall Medicina España S.A
Collaborating Sponsors:
University Hospital, Zürich
Conditions:
Allergy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. Many factors such as the biovariability, differences in extraction process a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Positive clinical history with inhalant allergy to at least one of the allergen to be standardized.
- At least one positive prick test (mean wheal diameter = 3mm) when tested with already standardized extracts of the allergens under investigation.
- Positive prick test (wheal diameter =3 mm) to Histamine 10 mg/ml
- Age: 18-60 years
- Written informed consent
- Exclusion criteria:
- Diseases or medications, influencing the skin tests or that contradict the correct conduct and evaluation of the study.
- Pregnancy, skin irritations, drug and alcohol abuse and participation in another clinical trial within the last 30 days
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01147159
Start Date
December 1 2010
End Date
April 1 2011
Last Update
May 2 2017
Active Locations (1)
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1
Zentrum für klinische Forschung Clinical Trials Center, University Hospital and University Zurich
Zurich, Switzerland, CH-8091