To determine the minimum amount of Platanus acerifolia allergen extractproducing a positive skin reaction.

• Conditions: Allergy to Platanus acerifolia; MedDRA version: 15.0Level: LLTClassification code 10036019Term: Pollen allergySystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-001938-34-ES
• Lead Sponsor: aboratorios Leti, S.L.Unipersonal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-23
• Last Update Posted: 9 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to assess the concentration of Platanus acerifolia allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.;Secondary Objective: In this study there are no secondary objectives;Primary end point(s): Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.;Timepoint(s) of evaluation of this end point: The primary endpoint will be determined after the last patient last visit(end of study).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): No secondary endpoints in this study;Timepoint(s) of evaluation of this end point: Not applicable