Biological Standardization of Platanus Acerifolia Allergen Extract

Biological Standardization of Platanus Acerifolia Allergen Extract to Determine the Biological Activity in HEP Units.

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

Study Overview

• Status: Completed
• Conditions: Allergy to Platanus Acerifolia
• Intervention / Treatment: Biological: Prick test Platanus acerifolia allergen extract

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 Platanus acerifolia 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): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Maranon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 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.
• Positive skin prick test with a standardized commercially available preparation of Platanus acerifolia 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 Platanus acerifolia (CAP-RAST major or equal to 2). IgE results are valid if performed within oneyear prior to the inclusion of the subject in the study.
• Allergic symptoms during the pollen season of Platanus acerifolia.
• Medical history positive allergy inhalation (rhinitis and /or rhinoconjunctivitis and/or asthma) from Platanus acerifolia.

Exclusion Criteria:

• Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested due to a high degree of cross-reactivity (for example:other species of Platanus: Platanus orientalis, Platanus occidentalis).
• 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

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: 1; Four concentrations of Platanus acerifolia allergen extract (10, 1, 0.1, 0.01 mg/ml) Positive control (10 mg/ml histamine dihydrochloride) Negative control (glycerinated phenol saline solution)

Biological: Prick test Platanus acerifolia allergen extract; This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Four concentrations of Platanus acerifolia 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. This test will be referred to as the Titrated Skin Prick test.; Other Names: Platanus acerifolia allergen extract.

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

Collaborators and Investigators

• Sponsor: Laboratorios Leti, S.L.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimate): December 3, 2012

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: skin prick test; inmunotherapy; standarization
• Other Study ID Numbers: 6022-PR-PRI-194