Biological Standardization of Platanus Acerifolia Allergen Extract

NCT ID: NCT01739322

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-07-31

Brief Summary

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).

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.

Conditions

Allergy to Platanus Acerifolia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Prick test Platanus acerifolia allergen extract

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Platanus acerifolia allergen extract.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Leti, S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Clinic

Barcelona, , Spain

Hospital Universitario Gregorio Marañón

Madrid, , Spain

Countries

Spain

Other Identifiers

6022-PR-PRI-194

Identifier Type: -

Identifier Source: org_study_id