Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus

April 28, 2017 updated by: Roxall Medicina España S.A

Biological Standardization of Allergen Extracts of Pollens of Betula Pendula, Phleum Pratense and Mite Extract of Dermatophagoides Pteronyssinus in Patients With Rhinoconjunctivitis With/ Without Asthma Sensitized to Betula Pendula, Dermatophagoides Pteronyssinus and Phleum Pratense An Open-label, Single-center Study

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 and subsequent handling of allergens can affect the final composition, potency, and stability of allergen preparations. Genetic diversity of affected people adds another level of complexity. 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. Therefore, the system for biological standardization mainly used in Europe still is the biological calibration of in-House Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT) value. The aim of this procedure is to estimate the biological activity of allergen extracts. The activity of an allergen extract is defined as 10,000 Diagnostic Biological Units (DBU) per ml (1 SPT per ml), when the extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned.

The present study aims to standardize the allergen extracts of Betula pendula, Phleum pratense and Dermatophagoides pteronyssinus by using this method.

  • Trial with medicinal product

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

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, CH-8091
        • Zentrum für klinische Forschung Clinical Trials Center, University Hospital and University Zurich

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Skin Prick Test
Other: Extracts of allergens
Skin prick test of extracts of allergens in 4 tenfold dilutions. Assessment wheal size after 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wheal size area
Time Frame: 15 minutes after skin prick test
The primary efficacy variable will be the wheal size area of the immediate phase reaction in mm2
15 minutes after skin prick test

Collaborators and Investigators

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

Sponsor

Roxall Medicina España S.A

Collaborators

University Hospital, Zürich

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

December 1, 2010

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

June 17, 2010

First Posted (ESTIMATE)

June 22, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • BIA-STD-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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