Biological Standardization of Blomia Tropicalis Allergen Extract

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT01597752
First received: May 10, 2012
Last updated: November 29, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Allergy to Mites
Biological: Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Biological Standardization of Blomia Tropicalis 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Blomia tropicalis allergen extract (four concentrations: 5, 0.5, 0.05, 0.005 mg/ml)

Positive control

Negative control

Biological: Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control
Four concentrations of Blomia tropicalis 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 Blomia tropicalis 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 Blomia tropicalis.
  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 Blomia tropicalis 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 Blomia tropicalis(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 season of Blomia tropicalis.
  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., mites 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597752

Locations
Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Canarias, Spain, 35012
Complejo Hospitalario Universitario Insular Materno-Insular
Las Palmas de Gran Canarias, Canarias, Spain, 35016
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: NCT01597752     History of Changes
Other Study ID Numbers: 107-PR-PRI-185, 2011-003634-14
Study First Received: May 10, 2012
Last Updated: November 29, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on August 01, 2014