Status:
TERMINATED
Phase II Study to Standardize Allergen Extracts: Determination of Biological Activity in HEP Units
Lead Sponsor:
University of Zurich
Conditions:
Allergy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Today a variety of diagnostic tools to detect allergenic agents are available such as skin tests, provocation tests and blood tests. Due to its high sensitivity and low costs the skin prick test is th...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 18-65 years old,
- a positive clinical history for inhalant allergy to at least one of the allergens to be tested,
- at least one positive prick test (mean wheal diameter = 3mm) when tested with already standardized extracts of the allergens under investigation.
- a mean wheal size of = 7mm2 obtained in a prick test with histamine dihydrochloride (10mg/ml).
- Written informed consent
- Exclusion criteria: -currently suffering from allergy symptoms,
- history of systemic reactions to allergens,
- severe diseases influencing the results of the present study by discretion of the investigator,
- immunotherapy with an allergen preparation known to interfere with the allergens under investigation during the past two years,
- skin lesions in the skin test areas
- pregnancy or nursing,
- treatment with prohibited concomitant medications (antihistamines, corticosteroids, anti-depressants, neuroleptics or specific immunotherapy)
- alcohol or drug abuse,
- impaired in understanding nature, meaning and the scope of the study or are incapable of giving written informed consent,
- Participation in another clinical trial within the last 30 days.
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01412528
Start Date
August 1 2009
End Date
January 1 2011
Last Update
August 9 2011
Active Locations (1)
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1
Clinical Trials Center
Zurich, Switzerland