To determine the minimum amount of Poa pratensis allergen extract producing a positive skin reaction.

• Conditions: Allergy to Poa pratensis.; MedDRA version: 14.0Level: LLTClassification code 10036019Term: Pollen allergySystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-023950-35-ES
• Lead Sponsor: aboratorios Leti, S.L.Unipersonal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-05
• Last Update Posted: 15 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• 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 > 18 years and < 50 years at the study inclusion day.
-Positive skin prick test with a standardized commercially available preparation of Lolium perenne allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. 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 Lolium perenne (CAP-RAST ? 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
-Allergic symptoms during the pollen season of Lolium perenne.
-Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ? 3 mm.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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 (e.g., grass group extracts).
-Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1
-Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, ?-blockers or corticosteroids (> 10 mg/day of prednisone or equivalent).
-Pregnancy.
-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.
-Participation in another clinical trial within the last month.
-Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension, ..)

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 Lolium perenne 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