To Determine the Minimum Amount of Alternaria Alternata Allergen Extract Producing a Positive Skin Reaction.

Biological Standardization of Alternaria Alternata Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP).

The objetive of this study is to determine the minimum amount of Alternaria alternata allergen extract producing in a positive skin reaction.

Study Overview

• Status: Completed
• Conditions: Allergy to Alternaria Fungus
• Intervention / Treatment: Biological: four differente concentrations of Alternaria alternata allergen extract, positive control and negative control

Detailed Description

This is an open, unblinded and non-randomized biological assay. The primary objective is to assess the concentration of alternaria alternata allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Clínico Universitario Virgen de la Arrixaca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Positive clinical history of inhalatory allergy to Alternaria alternata. Subject has provided written informed consent, appropriately signed and dated by the subject.

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.

Positive skin prick test with a standardized commercially available preparation of Alternaria alternata 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 wheal area ≥ 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 alternaria alternata (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.

The mean wheal diameters of the obtained with histamine dihydrochloride (10 mg / ml) in the forearm ≥ 3 mm.

Exclusion Criteria:

Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (for example: fungal extracts) Use of drugs that may interfere with the skin reactions (e.g., antihistamines). Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent).

Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 1 or 2.

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 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. Subjects who have received anti-IgE (Omalizumab).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prick Test; Alternaria alternata allergen extract Positve control Negative control	Biological: four differente concentrations of Alternaria alternata allergen extract, positive control and negative control; This concentrations will be tested in every patient in duplicate on the volar surface of the forearm.; Other Names: Four concentratios of Alternaria alternata together with a positive and negative control.

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.	Test sited chould be inspected and recorded 15-20 min after appliction

Collaborators and Investigators

• Sponsor: Laboratorios Leti, S.L.
• Investigators: Principal Investigator: Santiago Quirce, MD, Hospital Universitario La Paz; Principal Investigator: José Damian López, MD, HOSPITAL CLÍNICO UNIVERSITARIO VIRGEN DE LA

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 8, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (Estimate): November 14, 2013

Study Record Updates

• Last Update Posted (Estimate): January 5, 2015
• Last Update Submitted That Met QC Criteria: January 2, 2015
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Immunotherapy; Skin prick test; Standardization; Alternaria alternata
• Other Study ID Numbers: 301-PR-PRI-198; 2013-001308-13 (EudraCT Number)