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

NCT ID: NCT01147159

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-04-30

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 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

Conditions

Allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Skin Prick Test

Group Type: OTHER

Extracts of allergens

Intervention Type: OTHER

Skin prick test of extracts of allergens in 4 tenfold dilutions. Assessment wheal size after 15 minutes

Interventions

Extracts of allergens

Skin prick test of extracts of allergens in 4 tenfold dilutions. Assessment wheal size after 15 minutes

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

Roxall Medicina España S.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

Zentrum für klinische Forschung Clinical Trials Center, University Hospital and University Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

BIA-STD-001

Identifier Type: -

Identifier Source: org_study_id