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

Phase 2

Completed

• Conditions: Allergy
• Interventions: Other: Extracts of allergens

• Registration Number: NCT01147159
• Lead Sponsor: Roxall Medicina España S.A

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Study Start: 2010-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin Prick Test	Extracts of allergens	-

Primary Outcome Measures

Name	Time	Method
Wheal size area	15 minutes after skin prick test	The primary efficacy variable will be the wheal size area of the immediate phase reaction in mm2

Trial Locations

Locations (1)

Zentrum für klinische Forschung Clinical Trials Center, University Hospital and University Zurich; 🇨🇭 Zurich, Switzerland