Biological Standardization of Poa Pratensis Allergen Extract

Allergy to Grass Pollen Clinical Trial

Official title: Biological Standardization of Poa Pratensis Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units

Status Completed

Clinical Trial Summary

The objective of this study is to determine the biologic activity of a Poa pratensis allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

Clinical Trial Description

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Four concentrations of Poa pratensis allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Allergy to Grass Pollen
• Hypersensitivity

• NCT number: NCT01430117
• Study type: Interventional
• Source: Laboratorios Leti, S.L.
• Status: Completed
• Phase: Phase 2
• Start date: October 2011
• Completion date: February 2012