Biological Standardization of Lolium Perenne Allergen Extract

Allergy to Grass Pollen Clinical Trial

Official title:

Biological Standardization of Lolium Perenne Allergen Extract to Determine the Biological Activity in HEP Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394289
• Other study ID #: 6041-PR-PRI-182
• Secondary ID: 2010-023949-29
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2011
• Last updated: August 24, 2012
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: August 2011
• Source: Laboratorios Leti, S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

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

Description:

Four concentrations of Lolium perenne 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).

• Subject can be male or female of any race and ethnic group.

• Age > 18 years and < 50 years at the study inclusion day.

• Positive skin prick test with a standardized commercially available preparation of Lolium perenne allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study

• A positive test for specific IgE to Lolium perenne (CAP-RAST = 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.

• Allergic symptoms during the pollen season of Lolium perenne.

• Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) = 3 mm.

Exclusion Criteria:

• Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts).

• Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1

• Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, ß-blockers or corticosteroids (> 10 mg/day of prednisone or equivalent).

• Pregnancy.

• Dermographism affecting the skin area at the test site at either study visit.

• Atopic dermatitis affecting the skin area at the test site at either study visit.

• Urticaria affecting the skin area at the test site at either study visit.

• Participation in another clinical trial within the last month.

Study Design

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

Related Conditions & MeSH terms

• Allergy to Grass Pollen
• Hypersensitivity

Intervention

Biological:
• Lolium allergen extract
This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Four concentrations of Lolium perenne 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. This test will be referred to as the Titrated Skin Prick test.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Virgen del Rocío	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Leti, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.		30 minutes per subject	No