Biological Standardization of Lolium Perenne Allergen Extract

NCT01394289 | Completed Phase 2

• 2 other identifiers: 6041-PR-PRI-1822010-023949-29
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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).

Conditions

Allergy to Grass Pollen

Keywords

Standardization; Immunotherapy; Skin prick test

Outcome Measures

Primary Outcomes (1)

• Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.

  30 minutes per subject

Study Arms (1)

Biological/Vaccine: Lolium allergen extract

EXPERIMENTAL

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.

Biological: Lolium allergen extract

Interventions

Lolium allergen extract 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.

Biological/Vaccine: Lolium allergen extract

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorios Leti, S.L.: lead

Study Sites (2)

Hospital Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

Study Officials

• María José Gómez

  Laboratorios LETI, S.L.U

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 14, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 27, 2012

Record last verified: 2011-08

Locations

ES (2)