Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract

February 21, 2018 updated by: Laboratorios Leti, S.L.

Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract to Determine the Biological Activity in HEP Units.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Three concentrations of Dermatophagoides pteronyssinus 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

Enrollment (Actual)

42

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
      • La Coruña, Spain, 15001
        • Complexo Hospitalario Universitario A Coruña (Hospital Abente y Lago)
    • Alicante
      • Denia, Alicante, Spain, 03700
        • Hospital de Denia (Marina Salud)

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

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 > and =18 years and < and =60 years at the study inclusion day.
  • Medical history of allergy with respiratory symptoms (rhinitis and /or rhinoconjunctivitis and/or asthma) to Dermatophagoides pteronyssinus.
  • Positive skin prick test with a standardized commercially available preparation of Dermatophagoides pteronyssinus allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm or an area at least 7 mm2. 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 Dermatophagoides pteronyssinus (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.

Exclusion Criteria:

  • Immunotherapy in the past 5 years with a Dermatophagoides pteronyssinus allergen extract or other mites allergen extracts known to interfere with the allergen to be tested, due to a high degree of cross-reactivity.
  • Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 of the protocol.
  • Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants or IMAOs, beta-blockers, chronic use of corticosteroids or use of oral or parenteral corticosteroids in repeated and intermittent patterns (10 mg/daily of prednisone or equivalent).
  • Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the prick test.
  • 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.
  • Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
  • Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases,endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases.
  • Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.
  • Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension...)
  • Severe psychiatric, psychological or neurological disorders
  • Abuse of alcohol, drugs or medicines in the previous year.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1

Three concentrations of Dermatophagoides pteronyssinus allergen extract (10, 1, 0.1 mg/ml)

Positive control (10 mg/ml histamine dihydrochloride)

Negative control (glycerinated phenol saline solution)
Biological: Prick test Dermatophagoides pteronyssinus allergen extract

This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.

Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dichloride 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.

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: Test sites should be inspected and recorded 15-20 min after application
Test sites should be inspected and recorded 15-20 min after application

Collaborators and Investigators

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

Sponsor

Laboratorios Leti, S.L.

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

March 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

April 1, 2013

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101-PR-PRI-196

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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