NCT01821716

Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract

Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract to Determine the Biological Activity in HEP Units.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the biologic activity of a Dermatophagoides pteronyssinus 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. Three concentrations of Dermatophagoides pteronyssinus 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 Dermatophagoides Pteronyssinus
• Allergic Rhinitis
• Allergic Asthma

Interventions

Type	Name	Description
BIOLOGICAL	Prick test Dermatophagoides pteronyssinus allergen extract	This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dichloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-04-01
• Last updated: 2018-02-23

Locations

2 sites across 1 country: Spain