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Phase II Study to Standardize Allergen Extracts: Determination of Biological Activity in HEP Units

This study has been terminated.
(Recruitment problems)
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01412528
First received: April 28, 2010
Last updated: August 8, 2011
Last verified: January 2011
History of Changes
  Purpose

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 the most commonly used test to identify allergies in patients. By using this kind of skin test, up to 25 different agents can be tested in parallel, rendering the skin prick test a cheap, easy-to-handle and rapid diagnostic tool. However, as research proceeds, new tools appear with the intention to make future applications even more convenient -for both, the patient and the physician. For that purpose the development of the so called "Easyprick" Allergen Test System is under way, consisting of a foil that carries ready-to-use, allergen-soaked sponges which can easily be applied to the skin after pricking.

Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. In order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. The present study aims to standardize eight allergen extracts by using this method. Standardized extracts will then be applied in the Easyprick Allergen Test System which will be evaluated and compared to the conventional prick test in a second study.

  • Trial with medicinal product

Condition Intervention Phase
Allergy
 Other: Allergen extracts
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Wheal size
    15 minutes after skin prick test with a serial dilution of an allergen extracts, sizes of provoked wheals will be measured according to allergen standardization procedure.


Estimated Enrollment: 160
Study Start Date: August 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Eight different allergens will be standardized in this study Other: Allergen extracts

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412528

Locations
Switzerland
Clinical Trials Center
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Kuendig Thomas Dr., University hospital Zurich, Dermatology
ClinicalTrials.gov Identifier: NCT01412528     History of Changes
Other Study ID Numbers: ZU-EASY-001
Study First Received: April 28, 2010
Last Updated: August 8, 2011
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on May 21, 2013