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Biological Standardization of Lolium Perenne Allergen Extract

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ClinicalTrials.gov Identifier: NCT01394289
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.

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).

Condition or disease Intervention/treatment Phase
Allergy to Grass Pollen Biological: Lolium allergen extract Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biological Standardization of Lolium Perenne Allergen Extract to Determine the Biological Activity in HEP Units
Study Start Date : September 2011
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Histamine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. [ Time Frame: 30 minutes per subject ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394289


Locations
Spain
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
Study Chair: María José Gómez Laboratorios LETI, S.L.U

Responsible Party: Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier: NCT01394289     History of Changes
Other Study ID Numbers: 6041-PR-PRI-182
2010-023949-29
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: August 27, 2012
Last Verified: August 2011

Keywords provided by Laboratorios Leti, S.L.:
Standardization
Immunotherapy
Skin prick test

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs