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

August 8, 2011 updated by: University of Zurich

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • Clinical Trials Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Eight different allergens will be standardized in this study
Other: Allergen extracts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

August 8, 2011

First Posted (Estimate)

August 9, 2011

Study Record Updates

Last Update Posted (Estimate)

August 9, 2011

Last Update Submitted That Met QC Criteria

August 8, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • ZU-EASY-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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