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

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147159
• Other study ID #: BIA-STD-001
• Status: Completed
• Phase: Phase 2
• First received: May 25, 2010
• Last updated: April 28, 2017
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2017
• Source: Roxall Medicina España S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergy

Intervention

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

Locations

Country	Name	City	State
Switzerland	Zentrum für klinische Forschung Clinical Trials Center, University Hospital and University Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Roxall Medicina España S.A	University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wheal size area	The primary efficacy variable will be the wheal size area of the immediate phase reaction in mm2	15 minutes after skin prick test