Biological Standardization of Lolium Perenne Allergen Extract

NCT ID: NCT01394289

Last Updated: 2012-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-11-30

Brief 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).

Detailed 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.

Conditions

Allergy to Grass Pollen

Keywords

Standardization; Immunotherapy; Skin prick test

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Biological/Vaccine: Lolium allergen extract

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.

Group Type: EXPERIMENTAL

Lolium allergen extract

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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, β-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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Leti, S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

María José Gómez

Role: STUDY_CHAIR

Laboratorios LETI, S.L.U

Locations

Hospital Universitario de Salamanca

Salamanca, Salamanca, Spain

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Countries

Spain

Other Identifiers

2010-023949-29

Identifier Type: -

Identifier Source: secondary_id

6041-PR-PRI-182

Identifier Type: -

Identifier Source: org_study_id