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Biological Standardization of Dactylis Glomerata Allergen Extract

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01407835
First Posted: August 2, 2011
Last Update Posted: August 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laboratorios Leti, S.L.
  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: None (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

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 ]

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

Information from the National Library of Medicine

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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:

  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
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): 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

Responsible Party: Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier: NCT01407835     History of Changes
Other Study ID Numbers: 6038-PR-PRI-181
2010-023948-33 ( EudraCT Number )
First Submitted: August 1, 2011
First Posted: August 2, 2011
Last Update Posted: August 9, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases