Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).

June 17, 2011 updated by: Laboratorios Leti, S.L.
The main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

The skin testing procedure, based on the Nordic Guidelines is the reference method for the biological calibration of in-House Reference Preparations (IHRP). The method is not intended for routine testing of allergen extracts. The use of this procedure is the basis for the definition of biological activity units: "the activity of an allergen extract is 10,000 Biological Units (BU) per ml (10 HEP per ml), when the extract provokes an specific skin reaction in the median sensitive patient with a wheal of the same size as a wheal provoked by a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned".

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cadiz
      • Cádiz, Cadiz, Spain, 11008
        • Clinica Dr. Lobatón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Subject inclusion criteria:

  1. A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Glycyphagus domesticus.
  2. Positive skin prick test with an available preparation of the same allergen extract (a wheal major diameter of at least 3 mm) and/or a positive test for specific IgE.
  3. Mean of the areas of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 7 mm2.
  4. Age ≥ 18 years and ≤ 50 years
  5. Subject can be male or female
  6. Subject must be capable of providing written informed consent

Subject exclusion criteria:

  1. Subjects should not be excluded due to low or high sensitivity to Glycyphagus domesticus.
  2. Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.
  3. Use of drugs that may interfere with the skin reactions.
  4. Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.
  5. Any disease which prohibits the use of adrenaline (hyperthyroidism, arterial hypertension, cardiopathy, etc.)
  6. Lack of cooperation which may interfere with the study, or subjects with severe psychiatric, psychological or neurological disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Four concentrations of Glycyphagus domesticus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, was tested in every patient in duplicate on the volar surface of the forearm.
Other: Standardization of allergenic extract (Gly. domesticus)
Allergenic extract for cutaneous prick-test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Time Frame: 45 minutes per subject
45 minutes per subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Leti, S.L.

Investigators

  • Principal Investigator: Francisco Moreno, MD, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (ESTIMATE)

June 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2011

Last Update Submitted That Met QC Criteria

June 17, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108-PR-PRI-147
  • 2007-000904-33 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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