NCT01408238

Biological Standardization of Secale Cereale Allergen Extract

Biological Standardization of Secale Cereale Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 Secale cereale 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.

Conditions

• Allergy to Grass Pollen (Secale Cereale)

Interventions

Type	Name	Description
BIOLOGICAL	Four different concentrations of Secale cereale allergen extract, positive control and negative control	4 concentrations of Secale cereale allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-03-01
• Completion: 2012-06-01
• First posted: 2011-08-03
• Last updated: 2012-08-09

Locations

2 sites across 1 country: Spain