NCT01407835

Biological Standardization of Dactylis Glomerata Allergen Extract

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (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 Dactylis glomerata 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 Dactylis glomerata 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 (Dactylis Glomerata)

Interventions

Type	Name	Description
BIOLOGICAL	Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control	Four concentrations of Dactylis glomerata 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: 2011-08-02
• Last updated: 2012-08-09

Locations

2 sites across 1 country: Spain