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Biological Standardization of Dactylis Glomerata Allergen Extract

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT01407835
First received: August 1, 2011
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Allergy to Grass Pollen (Dactylis Glomerata)
 Biological: Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Biological Standardization of Dactylis Glomerata Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Laboratorios Leti, S.L.:

Primary Outcome Measures:
  • Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. [ Time Frame: Test sites should be inspected and recorded 15-20 min after application ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: October 2011
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
  • Dactylis glomerata allergen extract at 4 different concentrations
  • Positive control
  • Negative control
 Biological: Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control
Four concentrations of Dactylis glomerata allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.

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.

Four concentrations of Dactylis glomerata 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Dactylis glomerata.
  2. Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
  3. Subject can be male or female of any race and ethnic group.
  4. Age > 18 years and < 50 years at the study inclusion day.
  5. Positive skin prick test with a standardized commercially available preparation of Dactylis glomerata 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
  6. A positive test for specific IgE to Dactylis glomerata(CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
  7. Allergic symptoms during the pollen season of Dactylis glomerata.
  8. Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm.

Exclusion Criteria:

  1. Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts).
  2. Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1
  3. Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (> 10 mg/day of prednisone or equivalent).
  4. Pregnancy.
  5. Dermographism affecting the skin area at the test site at either study visit.
  6. Atopic dermatitis affecting the skin area at the test site at either study visit.
  7. Urticaria affecting the skin area at the test site at either study visit.
  8. Participation in another clinical trial within the last month.
  9. Subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension,..)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407835

Locations
Spain
Hospital Universitario La Princesa
Madrid, Madrid / Madrid, Spain, 28005
Hospital El Tomillar - Area Hospitalaria de Valme
Sevilla, Sevilla / Andalucía, Spain, 41700
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
Study Chair: María José Gómez Laboratorios LETI, S.L.Unipersonal
  More Information

No publications provided

Responsible Party: Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier: NCT01407835     History of Changes
Other Study ID Numbers: 6038-PR-PRI-181, 2010-023948-33
Study First Received: August 1, 2011
Last Updated: August 8, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013